Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.

Phase 1

• Conditions: Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-002902-29-IE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-28
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Men or women 18-75 years at the time of consent.
- Diagnosis of Crohn's disease at least 3 months prior to screening.
- Moderate to severe active Crohn's disease, defined as CDAI >or=220 and Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Complications of Crohn's disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery.
- Presence of ileostomy or colostomy.
- Pregnant or nursing women.
- Signs or symptoms suggestive of active TB.
- History of malignancy.

Study & Design

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