A

Phase 1

• Conditions: lcerative Colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-004676-22-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-13
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

Entry and completion of Study M16-067 or Study M16-065. Completion includes the final endoscopy of Study M16-067 or Study M16-065.

Achieved clinical response at the last visit of Study M16-067 or Study M16-065.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 or Study M16-065 that in the Investigator's judgment makes the subject unsuitable for this study.

Study & Design

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