A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

Phase 1

• Conditions: Crohn`s Disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-003824-36-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-25
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

- 18-80 years of age (inclusive)
- Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
- Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
- Use of effective contraception as defined by the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- A history of, or current conditions affecting the digestive tract, such as
ulcerative colitis, indeterminant colitis, abdominal or perianal abscess,
adenomatous colonic polyps, colonic mucosal dysplasia, and short bowel
syndrome
-Sinus tract with evidence for infection (e.g., Fistula with purulent
discharge) in the clinical judgment of the investigator. Fistulas related to
Crohn's disease are not exclusionary
- Planned surgery for CD
- Ileostomy or colostomy
- Has received non-permitted inflammatory bowel disease (IBD)
therapies (including natalizumab, vedolizumab, and efalizumab, as
stated in the protocol)
- Chronic hepatitis B or C infection, HIV, active or latent tuberculosis
(patients with prior history of BCG vaccination must pass protocoldefined
screening criteria)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified