A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

Phase 1

Conditions: Crohn's disease
MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-003191-50-SE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1250

Inclusion Criteria

1. Entry and completion of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study. The final endoscopy for studies M16-006 and M15-991 may be missing during the coronavirus SARS-CoV-2 pandemic due to local regulations prohibiting endoscopy and subjects may be allowed to enroll in Sub-study 3 should they meet clinical response.
2. Achieved clinical response, defined as = 30% decrease in average daily SF and/or = 30% decrease in average daily AP score, and both not worse than Baseline of the induction study, at the last visit of Study M16-006 or Study M15-991. This is not applicable for subjects enrolling from another AbbVie risankizumab Crohn's disease study.
3. If female, subject must meet the criteria as stated in protocol Contraception Recommendations.
4. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol, including self-administration or care giver administration of SC injections (if allowed per local requirements).

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Subjects should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter M16-000 or 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 006 , Study M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the subject unsuitable for this study.

Subject is not in compliance with prior and concomitant medication requirements throughout Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.

Confirmed positive urine pregnancy test at the Final Visit of Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.

Subject with any active or chronic recurring infections based on the Investigator's assessment makes the subject an unsuitable candidate for the study.

Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.