A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY<br>TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE<br>CROHN*S DISEASE

Phase 3

Completed

• Conditions: chronic bowel inflamation; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON47704
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

Patients must meet the following criteria for study entry:
- 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, A complete list of
inclusion criteria can be found in the protocol

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy objectives for ex-U.S. are:<br /><br>Induction Phase<br /><br>* Clinical remission at Week 14<br /><br>* Endoscopic improvement at Week 14<br /><br><br /><br><br /><br>Maintenance Phase, among patients who achieve CDAI-70 response at Week 14<br /><br>* Clinical remission at Week 66<br /><br>* Endoscopic improvement at Week 66</p><br>