A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with 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-GB
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-29
• Study Start: 2018-05-10
• Last Update Posted: 27 July 2020

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