Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 18.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-004098-26-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Study Completion: 2016-12-14
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
Men or women age 18 - 65 years at the time of screening.
Moderate-severe active CD, defined by a CDAI score of = 220 and = 450 at Day 1.
No known history of active TB.
Received at least one anti-TNFa agent for the treatment of CD and did not initially respond.

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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or breastfeeding women.
Presence of ileostomy and/or colostomy.
Short bowel syndrome.
Bowel performation or obstruction.
History of cancer.

Study & Design

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