A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 19.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003759-23-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Subject must have completed Study M13-740 through Week 52.
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

• For any reason subject is considered by the investigator to be an unsuitable candidate
• Female subject with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
• Subject is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Study & Design

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