A Study to Assess the Effectiveness and Safety of Risankizumab in Subjects with Ulcerative Colitis

Overview

About this study

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16-067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, subjects may be allowed to enroll in Substudy 3 should they meet clinical response. 
  • Achieved clinical response, defined as decrease in Adapted Mayo Score ≥ 2 points and ≥ 30% from Baseline, PLUS a decrease in RBS ≥ 1 or an absolute RBS ≤ 1 at the last visit of Study M16-067. For subjects with missing final endoscopy for Study M16-067 due to COVID-19 pandemic, clinical response is defined as a decrease in Partial Adapted Mayo Score ≥ 1 point and ≥ 30% from Baseline, PLUS a decrease in RBS ≥ 1 or an absolute RBS ≤ 1 at the last visit of Study M16-067.
  • If female, subject must meet the criteria as stated in Contraception Recommendations.
  • 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. In Japan, if the subject is < 20 years old, a subject's parent or legal guardian must be willing to give written informed consent.

Exclusion Criteria:

  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. Subjects should not be enrolled in Study M16-066 if high grade colonic dysplasia or colon cancer is discovered at the endoscopy performed at the final visit of Study M16-067. 
  • 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 that in the Investigator's judgment makes the subject unsuitable for this study.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-067.
  • Subject is not in compliance with prior and concomitant medication requirements throughout Study M16-067.
  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

Contact information:

IBD Clinical Research Unit

(507) 284-5908

More information

Publications

Publications are currently not available