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Completed

NCT Number: NCT02871635

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

Primary Objective:

The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gomel Regional Clinical, Homyel, Belarus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 695501

Drug

humira

Drug

Primary outcomes

  1. Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4

    Time frame: Week 4

    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).

Secondary outcomes

  1. Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24

    Time frame: Week 24

    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.

  2. Percentage of Patients in Clinical Remission (CDAI <150) at Week 24

    Time frame: at Week 24

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

  8. 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.

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2016
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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