A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn*s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha Therapy

Phase 2

Completed

• Conditions: Crohn's disease; 10017969

• Registration Number: NL-OMON46166
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Diagnosis of ileal, ileo-colonic, or colonic CD for > 3 months prior to
screening
- Men or women age 18 - 80 years at the time of screening
- Moderate to severely active CD, as defined by CDAI AND endoscopic
demonstration of inflammation
- Stable dose of medications for Crohn's disease therapy
- Prior treatment failure or intolerance with at least one anti-TNF* agent
-Effective contraception from screening, and for 26 weeks after the last
dose of investigational product
-No known history of active tuberculosis (TB) & negative assessment for
TB/latent TB

Exclusion Criteria

-Severe underlying immunosuppression
- Severe gastrointestinal complications; e.g., short bowel syndromes,
obstructing strictures, recent or planned bowel surgery, Ileostomy
and/or colostomy, recent bowel perforation
- Significant infections at screening; Infected abscess, positive for
Clostridium difficile, recent infectious hospitalization,
-Recent treatment with approved or investigational biologic therapy for
Crohn's disease
- Recent or planned live attenuated vaccine
- History of cancer, except for basal cell carcinoma or CIS of the cervix
with apparent cure * 12 months before screening
- Pregnancy/breast feeding
- Drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is CDAI remission at Week 8.</p><br>