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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02871635
• Date of registration: 15/08/2016
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
• Scientific title: BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
• Date of first enrolment: September 28, 2016
• Target sample size: 147
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02871635
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Belarus, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece, Israel, Poland, Russian Federation, Serbia, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Males and females aged >=18 and =<80 years at Screening who have a diagnosis of
moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic
evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must
have all of the following:

- Crohn's Disease Activity Index (CDAI) score of >=220 and =<450

- A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening

- Presence of mucosal ulcers in at least one segment of the ileum or colon and a
SES-CD score =7 (for patients with isolated ileal disease SES-CD score =4), as
assessed by ileocolonoscopy and confirmed by central independent reviewer(s)
before randomization

- Anti-tumor necrosis factor (TNF) patients or patients previously treated with
infliximab who had initially responded and who meet one of the following criteria:

- Responded and developed secondary resistance due confirmed anti-infliximab
anti-drug antibody formation, which caused infliximab depletion

- Responded and became intolerant

- Further inclusion criteria apply

Exclusion criteria:

- Patients with ulcerative colitis or indeterminate colitis

- Patients with symptomatic known obstructive strictures

- Surgical bowel resection performed within 6 months prior to Screening or planned
resection at any time while enrolled in the trial

- Patients with an ostomy or ileoanal pouch

- Patients with short bowel syndrome

- Patients who have previously used infliximab and have never clinically responded

- Patients who have previously received treatment with adalimumab, or who have
participated in an adalimumab or adalimumab biosimilar clinical trial

- Further exclusion criteria apply



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: BI 695501

Drug: HUMIRA

Primary Outcome(s)

Percentage of Patients With a Clinical Response (CDAI Decrease of =70 Compared With Baseline) at Week 4 [Time Frame: Week 4]

Secondary Outcome(s)

Percentage of Patients With a Clinical Response (CDAI Decrease of =70 Compared With Baseline) at Week 24 [Time Frame: Week 24]

Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 [Time Frame: at Week 24]

Percentage of Patients Who Experienced Hypersensitivity Reactions [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Percentage of Patients With Infections [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Percentage of Patients With Injection Site Reactions [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Percentage of Patients With Serious Infections [Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.]

Secondary ID(s)

2016-000612-14

1297.4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02871635