Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259308
Recruitment Status : Terminated (Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.)
First Posted : August 23, 2017
Results First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Ontamalimab
Drug: Placebo
Enrollment 279
Recruitment Details The study was conducted at 205 sites between 5 December 2017 (first participant first visit) and 06 October 2020 (last participant last visit).
Pre-assignment Details A total of 279 participants were enrolled and randomized in this study.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period. Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period. Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Period Title: Overall Study
Started 56 111 112
Completed 49 103 105
Not Completed 7 8 7
Reason Not Completed
Adverse Event             5             4             1
Withdrawal by Subject             2             1             3
Lost to Follow-up             0             0             1
Pregnancy             0             0             1
Protocol Deviation             0             3             0
Lack of Efficacy             0             0             1
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg Total
Hide Arm/Group Description Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period. Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period. Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period. Total of all reporting groups
Overall Number of Baseline Participants 56 111 112 279
Hide Baseline Analysis Population Description
Safety set consisted of all participants who had received at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 111 participants 112 participants 279 participants
41.6  (13.50) 43.5  (14.16) 43.9  (13.08) 43.3  (13.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 111 participants 112 participants 279 participants
Female
23
  41.1%
46
  41.4%
45
  40.2%
114
  40.9%
Male
33
  58.9%
65
  58.6%
67
  59.8%
165
  59.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 111 participants 112 participants 279 participants
Hispanic or Latino
5
   8.9%
17
  15.3%
16
  14.3%
38
  13.6%
Not Hispanic or Latino
51
  91.1%
93
  83.8%
96
  85.7%
240
  86.0%
Unknown or Not Reported
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 56 participants 111 participants 112 participants 279 participants
American Indian or Alaska Native
0
   0.0%
5
   4.5%
3
   2.7%
8
   2.9%
Asian: Japanese
6
  10.7%
5
   4.5%
6
   5.4%
17
   6.1%
Asian: Korean
4
   7.1%
5
   4.5%
8
   7.1%
17
   6.1%
Asian: Other
1
   1.8%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American
2
   3.6%
4
   3.6%
1
   0.9%
7
   2.5%
White
41
  73.2%
85
  76.6%
88
  78.6%
214
  76.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.4%
Multiple
1
   1.8%
5
   4.5%
1
   0.9%
7
   2.5%
Other (Unspecified)
1
   1.8%
1
   0.9%
5
   4.5%
7
   2.5%
1.Primary Outcome
Title Number of Participants With Remission Based on Composite Score at Week 12
Hide Description Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product (IP).
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
7
  12.5%
30
  27.0%
33
  29.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
2.Secondary Outcome
Title Number of Participants With Endoscopic Remission at Week 12
Hide Description Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
7
  12.5%
39
  35.1%
38
  33.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
3.Secondary Outcome
Title Number of Participants With Clinical Remission at Week 12
Hide Description Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
10
  17.9%
50
  45.0%
56
  50.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
4.Secondary Outcome
Title Number of Participants With Clinical Response Based on Composite Score at Week 12
Hide Description Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (>=) 1 point or a sub-score for rectal bleeding less than or equal to (<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
16
  28.6%
67
  60.4%
64
  57.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
5.Secondary Outcome
Title Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
Hide Description Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
6
  10.7%
35
  31.5%
30
  26.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ontamalimab 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.
6.Secondary Outcome
Title Number of Participants With Remission Based on Total Mayo Score at Week 12
Hide Description Remission was defined as a Total Mayo score of <=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
5
   8.9%
28
  25.2%
26
  23.2%
7.Secondary Outcome
Title Number of Participants With Clinical Response Based on Total Mayo Score at Week 12
Hide Description Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or an absolute sub-score for rectal bleeding <=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
19
  33.9%
66
  59.5%
63
  56.3%
8.Secondary Outcome
Title Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12
Hide Description The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.
Time Frame At Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
At Week 4
6
  10.7%
26
  23.4%
23
  20.5%
At Week 8
12
  21.4%
53
  47.7%
41
  36.6%
At Week 12
10
  17.9%
49
  44.1%
52
  46.4%
9.Secondary Outcome
Title Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8
Hide Description Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Time Frame At Weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
At Week 4
4
   7.1%
28
  25.2%
22
  19.6%
At Week 8
10
  17.9%
52
  46.8%
56
  50.0%
10.Secondary Outcome
Title Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12
Hide Description Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.8%
14
  12.6%
14
  12.5%
11.Secondary Outcome
Title Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12
Hide Description Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Time Frame At Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
At Week 4
0
   0.0%
15
  13.5%
12
  10.7%
At Week 8
5
   8.9%
29
  26.1%
19
  17.0%
At Week 12
6
  10.7%
36
  32.4%
26
  23.2%
12.Secondary Outcome
Title Number of Participants With Deep Remission at Week 12
Hide Description Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score <=1 and a centrally read Geboes score of <=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.8%
11
   9.9%
9
   8.0%
13.Secondary Outcome
Title Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12
Hide Description PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.69  (0.309) -2.49  (0.218) -1.83  (0.215)
14.Secondary Outcome
Title Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
Hide Description PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.41  (0.405) -3.50  (0.286) -2.87  (0.284)
15.Secondary Outcome
Title Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12
Hide Description PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.09  (0.373) -2.87  (0.263) -2.56  (0.264)
16.Secondary Outcome
Title Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
Hide Description PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.26  (0.386) -3.32  (0.272) -2.97  (0.272)
17.Secondary Outcome
Title Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12
Hide Description PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-2.05  (0.379) -3.74  (0.267) -3.41  (0.265)
18.Secondary Outcome
Title Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12
Hide Description Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 47 104 107
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.15  (0.246) -2.32  (0.173) -2.00  (0.172)
19.Secondary Outcome
Title Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12
Hide Description IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.
Time Frame Baseline, Weeks 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 53 108 106
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
IBDQ Bowel Function Dimension Score: Change at Week 8 Number Analyzed 53 participants 108 participants 106 participants
9.59  (1.611) 16.66  (1.189) 15.36  (1.180)
IBDQ Bowel Function Dimension Score: Change at Week 12 Number Analyzed 50 participants 104 participants 106 participants
9.51  (1.707) 17.71  (1.250) 15.86  (1.232)
IBDQ Emotional Status Dimension Score: Change at Week 8 Number Analyzed 53 participants 108 participants 106 participants
8.91  (1.701) 15.18  (1.255) 14.41  (1.247)
IBDQ Emotional Status Dimension Score: Change at Week 12 Number Analyzed 50 participants 104 participants 106 participants
9.94  (1.861) 14.84  (1.359) 14.73  (1.341)
IBDQ Systemic Symptoms Dimension Score: Change at Week 8 Number Analyzed 53 participants 108 participants 106 participants
3.84  (0.759) 6.61  (0.561) 5.86  (0.557)
IBDQ Systemic Symptoms Dimension Score: Change at Week 12 Number Analyzed 50 participants 104 participants 106 participants
3.85  (0.814) 7.34  (0.596) 6.04  (0.587)
IBDQ Social Function Dimension Score: Change at Week 8 Number Analyzed 53 participants 108 participants 106 participants
5.06  (0.873) 6.97  (0.643) 6.75  (0.640)
IBDQ Social Function Dimension Score: Change at Week 12 Number Analyzed 50 participants 104 participants 106 participants
5.09  (0.926) 7.68  (0.677) 7.03  (0.668)
20.Secondary Outcome
Title Change From Baseline in IBDQ Total Scores at Weeks 8 and 12
Hide Description IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.
Time Frame Baseline, Weeks 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 53 108 106
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
Change at Week 8 Number Analyzed 53 participants 108 participants 106 participants
27.56  (4.574) 45.63  (3.380) 42.58  (3.358)
Change at Week 12 Number Analyzed 50 participants 104 participants 106 participants
28.39  (4.990) 47.75  (3.649) 43.85  (3.604)
21.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12
Hide Description SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 50 104 106
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
Physical Component Summary: Change at Week 12 4.84  (0.982) 6.45  (0.721) 5.54  (0.709)
Mental Component Summary: Change at Week 12 2.09  (1.301) 7.37  (0.949) 6.68  (0.935)
22.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12
Hide Description SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 50 104 106
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
Physical Functioning: Change at Week 12 3.40  (0.901) 5.03  (0.657) 3.79  (0.646)
Role-Physical: Change at Week 12 4.47  (1.205) 7.39  (0.884) 6.90  (0.874)
Bodily Pain: Change at Week 12 5.55  (1.293) 8.18  (0.941) 7.06  (0.926)
General Health: Change at Week 12 3.93  (1.203) 7.00  (0.880) 6.34  (0.865)
Vitality: Change at Week 12 3.59  (1.381) 8.23  (1.008) 7.43  (0.993)
Social Functioning: Change at Week 12 3.59  (1.233) 7.43  (0.898) 6.54  (0.884)
Role-Emotional: Change at Week 12 1.27  (1.317) 5.79  (0.958) 5.68  (0.944)
Mental Health: Change at Week 12 3.56  (1.268) 7.90  (0.925) 6.47  (0.911)
23.Secondary Outcome
Title Number of Participants Based on Inpatient Hospitalization
Hide Description Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.
Time Frame From start of study up to follow up (Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 56 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
All-Cause Hospitalization
2
   3.6%
3
   2.7%
2
   1.8%
Gastrointestinal Related
1
   1.8%
2
   1.8%
1
   0.9%
Other Illness/Problem
1
   1.8%
2
   1.8%
2
   1.8%
Undergo Gastrointestinal Related Procedures
1
   1.8%
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Median Duration of Total Inpatient Days
Hide Description Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.
Time Frame From start of study up to follow-up (Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description:
Participants received placebo matched to ontamalimab subcutaneous (SC) injection, using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8 in a 12-week treatment period.
Participants received 25 milligrams (mg) of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Participants received 75 mg of ontamalimab SC injection, using a PFS on Week 0, Week 4 and Week 8 in a 12-week treatment period.
Overall Number of Participants Analyzed 2 3 2
Median (Full Range)
Unit of Measure: Days
10.5
(6 to 15)
7.0
(6 to 11)
2.0
(2 to 2)
Time Frame From start of study drug administration up to follow-up (Week 29)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Hide Arm/Group Description Participants received placebo matched to ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4, and Week 8. Participants received 25 milligram (mg) of ontamalimab SC injection using a PFS on Week 0, Week 4 and Week 8. Participants received 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.
All-Cause Mortality
Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)      0/111 (0.00%)      0/112 (0.00%)    
Hide Serious Adverse Events
Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/56 (7.14%)      5/111 (4.50%)      3/112 (2.68%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 1/112 (0.89%)  1
Leukopenia * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 0/112 (0.00%)  0
Cardiac disorders       
Supraventricular tachycardia * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 0/112 (0.00%)  0
Gastrointestinal disorders       
Colitis ulcerative * 1  3/56 (5.36%)  3 1/111 (0.90%)  1 1/112 (0.89%)  1
General disorders       
Asthenia * 1  0/56 (0.00%)  0 0/111 (0.00%)  0 1/112 (0.89%)  1
Infections and infestations       
Pneumonia * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 0/112 (0.00%)  0
Rash pustular * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 0/112 (0.00%)  0
Nervous system disorders       
Headache * 1  0/56 (0.00%)  0 1/111 (0.90%)  1 0/112 (0.00%)  0
Renal and urinary disorders       
Hydrocalyx * 1  1/56 (1.79%)  1 0/111 (0.00%)  0 0/112 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ontamalimab 25 mg Ontamalimab 75 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/56 (12.50%)      5/111 (4.50%)      7/112 (6.25%)    
Blood and lymphatic system disorders       
Anaemia * 1  4/56 (7.14%)  5 2/111 (1.80%)  2 7/112 (6.25%)  9
Gastrointestinal disorders       
Nausea * 1  4/56 (7.14%)  5 3/111 (2.70%)  3 2/112 (1.79%)  3
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Shire )
ClinicalTrials.gov Identifier: NCT03259308    
Other Study ID Numbers: SHP647-302
2017-000572-28 ( EudraCT Number )
First Submitted: August 21, 2017
First Posted: August 23, 2017
Results First Submitted: March 26, 2021
Results First Posted: April 26, 2021
Last Update Posted: April 26, 2021