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

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ClinicalTrials.gov Identifier: NCT02871635
Recruitment Status : Active, not recruiting
First Posted : August 18, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: BI 695501 Drug: HUMIRA Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : March 28, 2019
Estimated Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: BI 695501 Drug: BI 695501
Active Comparator: HUMIRA + BI 695501 Drug: BI 695501
Drug: HUMIRA



Primary Outcome Measures :
  1. Proportion of patients in each treatment group with a clinical response (Crohn's Disease Activity Index decrease of >=70 compared with baseline) at Week 4 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients who experience hypersensitivity reactions [ Time Frame: 56 weeks ]
  2. Proportion of patients with injection-site reactions [ Time Frame: 56 weeks ]
  3. Proportion of patients in each treatment group with a clinical response (Crohn's Disease Activity Index decrease of >=70 compared with baseline) at Week 24 [ Time Frame: 24 weeks ]
  4. Proportion of patients in each treatment group in clinical remission (Crohn's Disease Activity Index <150) at Week 24 [ Time Frame: 24 weeks ]
  5. Proportion of patients with adverse events, serious adverse events, and adverse events of special interests [ Time Frame: 56 weeks ]
  6. Proportion of patients with infections/serious infections (seriousness of infection defined as requirement of intravenous antibiotics for treatment and/or meeting seriousness criteria to be qualified as an serious adverse event) [ Time Frame: 56 weeks ]
  7. Proportion of patients who experience Drug Induced Liver Injury [ Time Frame: 56 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871635


  Show 130 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02871635     History of Changes
Other Study ID Numbers: 1297.4
2016-000612-14 ( EudraCT Number )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents