Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

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: NCT02871635
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn Disease
Interventions Drug: BI 695501
Drug: HUMIRA
Enrollment 147
Recruitment Details This was an exploratory, randomized, 56-week, double-blind, parallel arm, multiple dose, active comparator trial of BI 695501 and EU-approved Humira, with a 48-week treatment period and a 10-week follow-up period (starting after last dose of trial medication at Week 46) in patients with moderately to severely active Crohn's Disease (CD)
Pre-assignment Details The trial consisted of a screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Period Title: Overall Study
Started 72 75
Completed 54 56
Not Completed 18 19
Reason Not Completed
Primary lack of efficacy             4             4
Protocol Violation             3             1
Lost to Follow-up             1             2
Pregnancy             0             2
Physician Decision             1             1
Withdrawal by Subject             3             4
Adverse Event             4             4
Secondary lack of efficacy             2             1
Arm/Group Title BI 695501 Humira EU Total
Hide Arm/Group Description

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Total of all reporting groups
Overall Number of Baseline Participants 72 75 147
Hide Baseline Analysis Population Description
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 75 participants 147 participants
37.4  (13.44) 33.2  (11.52) 35.3  (12.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 75 participants 147 participants
Female
33
  45.8%
31
  41.3%
64
  43.5%
Male
39
  54.2%
44
  58.7%
83
  56.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 75 participants 147 participants
Hispanic or Latino
1
   1.4%
0
   0.0%
1
   0.7%
Not Hispanic or Latino
69
  95.8%
67
  89.3%
136
  92.5%
Unknown or Not Reported
2
   2.8%
8
  10.7%
10
   6.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 75 participants 147 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.4%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.4%
1
   1.3%
2
   1.4%
White
69
  95.8%
74
  98.7%
143
  97.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.4%
0
   0.0%
1
   0.7%
Crohn's Disease Activity Index score at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 72 participants 75 participants 147 participants
307.3  (76.69) 303.6  (64.39) 305.4  (70.46)
[1]
Measure Description: Crohn's Disease Activity Index (CDAI) is a valid instrument to measure severity in Crohn's disease. The CDAI is composed of 8 factors (Number of liquid stools, abdominal pain, general well being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit, body weight) the score is calculated by adding up the scores after adjustment with a weighting factor. The total score ranges from 0 to approx. 600, higher scores indicates more severe disease. A score of less than or equal to 150 is evaluated as a remission while 220 and 450 indicate moderate to severely active disease.
1.Primary Outcome
Title Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
Hide Description

The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.

The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.

Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: Percentage of participants
88.0 93.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.945
Confidence Interval (2-Sided) 90%
0.870 to 1.028
Estimation Comments BI 695501 as numerator Humira EU as denominator
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.945
Confidence Interval (2-Sided) 95%
0.856 to 1.044
Estimation Comments BI 695501 as numerator Humira EU as denominator
2.Secondary Outcome
Title Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
Hide Description

The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.

The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.

Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: Percentage of participants
87.4 87.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.000
Confidence Interval (2-Sided) 90%
0.871 to 1.148
Estimation Comments BI 695501 as numerator Humira EU as denominator
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.000
Confidence Interval (2-Sided) 95%
0.848 to 1.178
Estimation Comments BI 695501 as numerator Humira EU as denominator
3.Secondary Outcome
Title Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
Hide Description

The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.

Patients with CDAI <150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: Percentage of participants
68.6 76.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.900
Confidence Interval (2-Sided) 90%
0.751 to 1.078
Estimation Comments BI 695501 as numerator Humira EU as denominator
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 695501, Humira EU
Comments Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9000
Confidence Interval (2-Sided) 95%
0.725 to 1.116
Estimation Comments BI 695501 as numerator Humira EU as denominator
4.Secondary Outcome
Title Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Hide Description Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
TEAE -Period 1 62.5 56.0
serious TEAE - Period 1 8.3 10.7
AESI TEAE - Period 1 2.8 2.7
TEAE - Period 2 43.1 45.3
serious TEAE - Period 2 2.8 12.0
AESI TEAE - Period 2 2.8 2.7
5.Secondary Outcome
Title Percentage of Patients With Infections
Hide Description The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 23.6 22.7
Period 2 19.4 22.7
6.Secondary Outcome
Title Percentage of Patients With Serious Infections
Hide Description The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 2.8 2.7
Period 2 1.4 4.0
7.Secondary Outcome
Title Percentage of Patients Who Experienced Hypersensitivity Reactions
Hide Description The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 5.6 2.7
Period 2 2.8 6.7
8.Secondary Outcome
Title Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
Hide Description The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 0.0 0.0
Period 2 0.0 0.0
9.Secondary Outcome
Title Percentage of Patients With Injection Site Reactions
Hide Description The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Arm/Group Title BI 695501 Humira EU
Hide Arm/Group Description:

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Overall Number of Participants Analyzed 72 75
Measure Type: Number
Unit of Measure: Percentage of participants
Period 1 0.0 6.7
Period 2 1.4 1.3
Time Frame From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Adverse Event Reporting Description The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
 
Arm/Group Title BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days]) Humira (Baseline - Week 24 + 10 Weeks [70 Days]) BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days]) Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
Hide Arm/Group Description

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).

Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).

Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

All-Cause Mortality
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days]) Humira (Baseline - Week 24 + 10 Weeks [70 Days]) BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days]) Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/75 (0.00%)   0/72 (0.00%)   0/75 (0.00%) 
Hide Serious Adverse Events
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days]) Humira (Baseline - Week 24 + 10 Weeks [70 Days]) BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days]) Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/72 (8.33%)   8/75 (10.67%)   2/72 (2.78%)   9/75 (12.00%) 
Gastrointestinal disorders         
Crohn's disease  1  2/72 (2.78%)  5/75 (6.67%)  1/72 (1.39%)  1/75 (1.33%) 
Anal fistula  1  1/72 (1.39%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Large intestinal haemorrhage  1  0/72 (0.00%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Small intestinal obstruction  1  0/72 (0.00%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Dyspepsia  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Pancreatitis chronic  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
General disorders         
Non-cardiac chest pain  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Infections and infestations         
Acute sinusitis  1  1/72 (1.39%)  0/75 (0.00%)  0/72 (0.00%)  0/75 (0.00%) 
Anal abscess  1  0/72 (0.00%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Postoperative wound infection  1  0/72 (0.00%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Pulmonary tuberculosis  1  1/72 (1.39%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Psoas abscess  1  0/72 (0.00%)  0/75 (0.00%)  1/72 (1.39%)  0/75 (0.00%) 
Rotavirus infection  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Upper respiratory tract infection  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications         
Joint injury  1  1/72 (1.39%)  0/75 (0.00%)  0/72 (0.00%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders         
Joint swelling  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Musculoskeletal pain  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Nervous system disorders         
Multiple sclerosis  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Pregnancy, puerperium and perinatal conditions         
Ruptured ectopic pregnancy  1  0/72 (0.00%)  1/75 (1.33%)  0/72 (0.00%)  0/75 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Palmoplantar pustulosis  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Pruritus  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Pyoderma gangrenosum  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Rash erythematous  1  0/72 (0.00%)  0/75 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days]) Humira (Baseline - Week 24 + 10 Weeks [70 Days]) BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days]) Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/72 (31.94%)   16/75 (21.33%)   13/72 (18.06%)   12/75 (16.00%) 
Gastrointestinal disorders         
Crohn's disease  1  4/72 (5.56%)  3/75 (4.00%)  0/72 (0.00%)  2/75 (2.67%) 
Abdominal pain  1  3/72 (4.17%)  2/75 (2.67%)  1/72 (1.39%)  5/75 (6.67%) 
Infections and infestations         
Respiratory tract infection  1  5/72 (6.94%)  3/75 (4.00%)  0/72 (0.00%)  3/75 (4.00%) 
Upper respiratory tract infection  1  3/72 (4.17%)  5/75 (6.67%)  2/72 (2.78%)  1/75 (1.33%) 
Nasopharyngitis  1  2/72 (2.78%)  2/75 (2.67%)  5/72 (6.94%)  3/75 (4.00%) 
Investigations         
Weight increased  1  4/72 (5.56%)  1/75 (1.33%)  3/72 (4.17%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/72 (8.33%)  0/75 (0.00%)  2/72 (2.78%)  0/75 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02871635    
Other Study ID Numbers: 1297.4
2016-000612-14 ( EudraCT Number )
First Submitted: August 15, 2016
First Posted: August 18, 2016
Results First Submitted: April 23, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020