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 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: EUCTR2015-000609-38-HU
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-24
• Study Completion: 2018-01-29
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 29

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-TNFa 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
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 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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 clinical trial of medicinal product
• Study Design: Not specified