Phase 3
Completed N=147
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Crohn Disease
Source: ClinicalTrials.gov NCT02871635 ↗
Enrolled (actual)
147
Serious AEs
8.5%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 — 88.0; 93.1 Percentage of participants
◆ Published Evidence
Established
40citations · ~8 / year
Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial.
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.
Linked Publications (4)
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Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial.
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Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials.
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Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials.
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Plain language summary of the VOLTAIRE-CD study in people with moderate-to-severe active Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 |
88.0; 93.1 | — |
| SECONDARY Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 |
87.4; 87.4 | — |
| SECONDARY Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 |
68.6; 76.2 | — |
| SECONDARY Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) |
62.5; 56.0; 8.3; 10.7; 2.8; 2.7 | — |
| SECONDARY Percentage of Patients With Infections |
23.6; 22.7; 19.4; 22.7 | — |
| SECONDARY Percentage of Patients With Serious Infections |
2.8; 2.7; 1.4; 4.0 | — |
| SECONDARY Percentage of Patients Who Experienced Hypersensitivity Reactions |
5.6; 2.7; 2.8; 6.7 | — |
| SECONDARY Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Patients With Injection Site Reactions |
0.0; 6.7; 1.4; 1.3 | — |
Eligibility Criteria
Inclusion criteria
- Males and females aged >=18 and = =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
Data sourced from ClinicalTrials.gov (NCT02871635) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.