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Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02405442
Recruitment Status : Terminated
First Posted : April 1, 2015
Results First Posted : March 28, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: Andecaliximab
Drug: Placebo
Enrollment 187
Recruitment Details Participants were enrolled at study sites in North America, Europe, South Africa, and Asia Pacific. The first participant was screened on 30 April 2015. The last study visit occurred on 22 December 2016.
Pre-assignment Details 315 participants were screened.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo
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Double-Blind Phase: Participants received 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Period Title: Double-Blind Phase (up to Week 8)
Started 53 53 53 28
Completed 52 48 47 27
Not Completed 1 5 6 1
Reason Not Completed
Adverse Event             0             2             4             1
Withdrew Consent             0             1             2             0
Study Disease-Related Symptoms             1             1             0             0
Investigator's Discretion             0             1             0             0
Period Title: Open-Label Phase (up to Week 52)
Started 52 48 47 26 [1]
Completed 4 3 2 2
Not Completed 48 45 45 24
Reason Not Completed
Study Terminated by Sponsor             27             28             28             13
Investigator's Discretion             14             11             11             2
Adverse Event             6             1             2             6
Study Disease-Related Symptoms             0             1             3             2
Withdrew Consent             1             2             1             1
Lack of Efficacy             0             1             0             0
Lost to Follow-up             0             1             0             0
[1]
1 participant completed Double-Blind Phase, but did not continue in Open-Label Phase.
Period Title: Extended Treatment Phase(up to Week 208)
Started 3 [1] 2 [1] 2 2
Completed 0 0 0 0
Not Completed 3 2 2 2
Reason Not Completed
Study Terminated by Sponsor             2             1             2             2
Investigator's Discretion             0             1             0             0
Study Disease-Related Symptoms             1             0             0             0
[1]
1 participant completed Open-Label Phase, but did not continue in Extended Treatment Phase.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo Total
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Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Total of all reporting groups
Overall Number of Baseline Participants 53 53 53 28 187
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 53 participants 53 participants 28 participants 187 participants
38  (12.8) 39  (13.5) 42  (11.7) 38  (13.5) 39  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 53 participants 28 participants 187 participants
Female
25
  47.2%
28
  52.8%
22
  41.5%
15
  53.6%
90
  48.1%
Male
28
  52.8%
25
  47.2%
31
  58.5%
13
  46.4%
97
  51.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 53 participants 53 participants 53 participants 28 participants 187 participants
Asian
1
   1.9%
1
   1.9%
0
   0.0%
1
   3.6%
3
   1.6%
Black or African American
3
   5.7%
4
   7.5%
3
   5.7%
1
   3.6%
11
   5.9%
White
48
  90.6%
42
  79.2%
48
  90.6%
22
  78.6%
160
  85.6%
Other
1
   1.9%
0
   0.0%
1
   1.9%
3
  10.7%
5
   2.7%
Not Permitted
0
   0.0%
6
  11.3%
1
   1.9%
1
   3.6%
8
   4.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 53 participants 53 participants 53 participants 28 participants 187 participants
Hispanic or Latino
1
   1.9%
1
   1.9%
5
   9.4%
1
   3.6%
8
   4.3%
Not Hispanic or Latino
52
  98.1%
46
  86.8%
47
  88.7%
26
  92.9%
171
  91.4%
Not Permitted
0
   0.0%
6
  11.3%
1
   1.9%
1
   3.6%
8
   4.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 53 participants 28 participants 187 participants
Hungary
2
   3.8%
1
   1.9%
0
   0.0%
2
   7.1%
5
   2.7%
United States
29
  54.7%
28
  52.8%
30
  56.6%
17
  60.7%
104
  55.6%
Czechia
1
   1.9%
2
   3.8%
1
   1.9%
1
   3.6%
5
   2.7%
United Kingdom
2
   3.8%
2
   3.8%
2
   3.8%
0
   0.0%
6
   3.2%
Spain
3
   5.7%
0
   0.0%
2
   3.8%
0
   0.0%
5
   2.7%
New Zealand
4
   7.5%
1
   1.9%
0
   0.0%
0
   0.0%
5
   2.7%
Canada
3
   5.7%
1
   1.9%
0
   0.0%
0
   0.0%
4
   2.1%
Poland
3
   5.7%
5
   9.4%
6
  11.3%
2
   7.1%
16
   8.6%
Italy
0
   0.0%
0
   0.0%
1
   1.9%
1
   3.6%
2
   1.1%
South Africa
0
   0.0%
0
   0.0%
2
   3.8%
1
   3.6%
3
   1.6%
Australia
3
   5.7%
2
   3.8%
3
   5.7%
1
   3.6%
9
   4.8%
France
0
   0.0%
6
  11.3%
1
   1.9%
1
   3.6%
8
   4.3%
Germany
3
   5.7%
5
   9.4%
5
   9.4%
2
   7.1%
15
   8.0%
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
Hide Description Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
Time Frame Week 8
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Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo
Hide Arm/Group Description:

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Overall Number of Participants Analyzed 53 53 53 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.0
(8.1 to 29.8)
13.2
(5.5 to 25.3)
11.3
(4.3 to 23.0)
14.3
(4.0 to 32.7)
2.Primary Outcome
Title Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
Hide Description Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.
Time Frame Week 8
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Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo
Hide Arm/Group Description:

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Overall Number of Participants Analyzed 53 53 53 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.3
(4.3 to 23.0)
13.2
(5.5 to 25.3)
7.5
(2.1 to 18.2)
10.7
(2.3 to 28.2)
3.Secondary Outcome
Title Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
Hide Description Clinical remission was defined as Crohn’s Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo
Hide Arm/Group Description:

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Overall Number of Participants Analyzed 53 53 53 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.8
(10.8 to 34.1)
17.0
(8.1 to 29.8)
11.3
(4.3 to 23.0)
21.4
(8.3 to 41.0)
4.Secondary Outcome
Title Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
Hide Description The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.
Time Frame Week 8
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Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly Placebo
Hide Arm/Group Description:

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.

Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.

Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Overall Number of Participants Analyzed 53 53 53 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.7
(1.2 to 15.7)
1.9
(0.0 to 10.1)
1.9
(0.0 to 10.1)
7.1
(0.9 to 23.5)
Time Frame Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Adverse Event Reporting Description Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
 
Arm/Group Title Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W) Double-Blind Andecaliximab 150 mg Weekly (QW) Double-Blind Andecaliximab 300 mg Weekly Double-Blind Placebo Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW From Andecaliximab 150 mg QW Open-Label Andecaliximab QW From Andecaliximab 300 mg QW Open-Label Andecaliximab QW From Placebo
Hide Arm/Group Description Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 1 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks. Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Every 2 Weeks group. Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Weekly group. Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 300 mg Every 2 Weeks group. Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Placebo group.
All-Cause Mortality
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W) Double-Blind Andecaliximab 150 mg Weekly (QW) Double-Blind Andecaliximab 300 mg Weekly Double-Blind Placebo Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW From Andecaliximab 150 mg QW Open-Label Andecaliximab QW From Andecaliximab 300 mg QW Open-Label Andecaliximab QW From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/53 (0.00%)   0/53 (0.00%)   0/28 (0.00%)   0/52 (0.00%)   0/48 (0.00%)   0/47 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W) Double-Blind Andecaliximab 150 mg Weekly (QW) Double-Blind Andecaliximab 300 mg Weekly Double-Blind Placebo Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW From Andecaliximab 150 mg QW Open-Label Andecaliximab QW From Andecaliximab 300 mg QW Open-Label Andecaliximab QW From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/53 (1.89%)   6/53 (11.32%)   8/53 (15.09%)   3/28 (10.71%)   9/52 (17.31%)   10/48 (20.83%)   7/47 (14.89%)   6/26 (23.08%) 
Blood and lymphatic system disorders                 
Anaemia  1  0/53 (0.00%)  1/53 (1.89%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/26 (3.85%) 
Gastrointestinal disorders                 
Abdominal pain  1  0/53 (0.00%)  1/53 (1.89%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/26 (0.00%) 
Anal fistula  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  1/28 (3.57%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Constipation  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Crohn's disease  1  0/53 (0.00%)  3/53 (5.66%)  2/53 (3.77%)  0/28 (0.00%)  4/52 (7.69%)  5/48 (10.42%)  4/47 (8.51%)  3/26 (11.54%) 
Fistula of small intestine  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  1/52 (1.92%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Ileal stenosis  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  1/52 (1.92%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Intestinal obstruction  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  1/52 (1.92%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Intestinal perforation  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  1/52 (1.92%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Large intestinal stenosis  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Large intestine perforation  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Proctalgia  1  0/53 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Rectal haemorrhage  1  0/53 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Small intestinal obstruction  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  2/52 (3.85%)  1/48 (2.08%)  2/47 (4.26%)  0/26 (0.00%) 
Infections and infestations                 
Abdominal abscess  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  1/52 (1.92%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Anal abscess  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Appendicitis  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/26 (3.85%) 
Bacterial pyelonephritis  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/26 (3.85%) 
Clostridium difficile infection  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Cytomegalovirus infection  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/26 (0.00%) 
Enteritis infectious  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Perirectal abscess  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/28 (3.57%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Pneumonia  1  1/53 (1.89%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Injury, poisoning and procedural complications                 
Post procedural complication  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/26 (0.00%) 
Post procedural haematoma  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Post procedural haemorrhage  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Procedural pain  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders                 
Hypocalcaemia  1  1/53 (1.89%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Hypokalaemia  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Nervous system disorders                 
Paraesthesia  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/28 (3.57%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Renal and urinary disorders                 
Acute kidney injury  1  0/53 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Acute prerenal failure  1  1/53 (1.89%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Nephrolithiasis  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  1/28 (3.57%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders                 
Acne  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Vascular disorders                 
Peripheral ischaemia  1  1/53 (1.89%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W) Double-Blind Andecaliximab 150 mg Weekly (QW) Double-Blind Andecaliximab 300 mg Weekly Double-Blind Placebo Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W Open-Label Andecaliximab QW From Andecaliximab 150 mg QW Open-Label Andecaliximab QW From Andecaliximab 300 mg QW Open-Label Andecaliximab QW From Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/53 (28.30%)   25/53 (47.17%)   25/53 (47.17%)   13/28 (46.43%)   22/52 (42.31%)   21/48 (43.75%)   17/47 (36.17%)   16/26 (61.54%) 
Blood and lymphatic system disorders                 
Anaemia  1  0/53 (0.00%)  2/53 (3.77%)  6/53 (11.32%)  0/28 (0.00%)  1/52 (1.92%)  1/48 (2.08%)  1/47 (2.13%)  1/26 (3.85%) 
Gastrointestinal disorders                 
Abdominal pain  1  1/53 (1.89%)  7/53 (13.21%)  4/53 (7.55%)  3/28 (10.71%)  7/52 (13.46%)  1/48 (2.08%)  3/47 (6.38%)  1/26 (3.85%) 
Crohn's disease  1  1/53 (1.89%)  1/53 (1.89%)  2/53 (3.77%)  2/28 (7.14%)  6/52 (11.54%)  10/48 (20.83%)  4/47 (8.51%)  5/26 (19.23%) 
Nausea  1  3/53 (5.66%)  1/53 (1.89%)  7/53 (13.21%)  5/28 (17.86%)  3/52 (5.77%)  4/48 (8.33%)  1/47 (2.13%)  2/26 (7.69%) 
Vomiting  1  2/53 (3.77%)  1/53 (1.89%)  1/53 (1.89%)  1/28 (3.57%)  3/52 (5.77%)  0/48 (0.00%)  2/47 (4.26%)  0/26 (0.00%) 
General disorders                 
Fatigue  1  6/53 (11.32%)  0/53 (0.00%)  5/53 (9.43%)  1/28 (3.57%)  1/52 (1.92%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Pyrexia  1  1/53 (1.89%)  3/53 (5.66%)  0/53 (0.00%)  4/28 (14.29%)  2/52 (3.85%)  1/48 (2.08%)  2/47 (4.26%)  2/26 (7.69%) 
Infections and infestations                 
Clostridium difficile infection  1  0/53 (0.00%)  1/53 (1.89%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  2/26 (7.69%) 
Herpes zoster  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  2/28 (7.14%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Nasopharyngitis  1  2/53 (3.77%)  1/53 (1.89%)  4/53 (7.55%)  0/28 (0.00%)  4/52 (7.69%)  3/48 (6.25%)  4/47 (8.51%)  1/26 (3.85%) 
Rhinitis  1  1/53 (1.89%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  2/26 (7.69%) 
Upper respiratory tract infection  1  1/53 (1.89%)  0/53 (0.00%)  1/53 (1.89%)  2/28 (7.14%)  1/52 (1.92%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
Urinary tract infection  1  1/53 (1.89%)  2/53 (3.77%)  1/53 (1.89%)  1/28 (3.57%)  0/52 (0.00%)  3/48 (6.25%)  1/47 (2.13%)  1/26 (3.85%) 
Injury, poisoning and procedural complications                 
Contusion  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  3/52 (5.77%)  0/48 (0.00%)  0/47 (0.00%)  0/26 (0.00%) 
Investigations                 
Hepatic enzyme increased  1  0/53 (0.00%)  0/53 (0.00%)  0/53 (0.00%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  2/26 (7.69%) 
Metabolism and nutrition disorders                 
Hypokalaemia  1  1/53 (1.89%)  3/53 (5.66%)  4/53 (7.55%)  1/28 (3.57%)  2/52 (3.85%)  2/48 (4.17%)  1/47 (2.13%)  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  0/53 (0.00%)  4/53 (7.55%)  1/53 (1.89%)  2/28 (7.14%)  2/52 (3.85%)  0/48 (0.00%)  1/47 (2.13%)  2/26 (7.69%) 
Back pain  1  1/53 (1.89%)  2/53 (3.77%)  0/53 (0.00%)  2/28 (7.14%)  0/52 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  1/26 (3.85%) 
Nervous system disorders                 
Dizziness  1  0/53 (0.00%)  5/53 (9.43%)  2/53 (3.77%)  0/28 (0.00%)  0/52 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/26 (0.00%) 
Headache  1  0/53 (0.00%)  4/53 (7.55%)  5/53 (9.43%)  1/28 (3.57%)  2/52 (3.85%)  1/48 (2.08%)  1/47 (2.13%)  0/26 (0.00%) 
Renal and urinary disorders                 
Nephrolithiasis  1  0/53 (0.00%)  0/53 (0.00%)  1/53 (1.89%)  2/28 (7.14%)  2/52 (3.85%)  1/48 (2.08%)  0/47 (0.00%)  0/26 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
A prespecified topline analysis was performed after the last enrolled subject received the 8-week Double-Blind induction treatment. Based on this review, Gilead terminated the Open-Label and Extended Treatment Phases of study due to lack of efficacy.
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02405442     History of Changes
Other Study ID Numbers: GS-US-395-1663
2015-001249-10 ( EudraCT Number )
First Submitted: March 27, 2015
First Posted: April 1, 2015
Results First Submitted: March 5, 2019
Results First Posted: March 28, 2019
Last Update Posted: April 23, 2019