A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Overview

About this study

The study consists of 3 sub-studies, as follows: 

Sub-study 1 (Randomized, double-blind, placebo controlled study)

  • The purpose is to evaluate the effectiveness and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately-to-severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-study 2 (Randomized, exploratory maintenance study)

  • The purpose is to evaluate the effectiveness and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.

Sub-study 3 (Open-label, long-term extension study)

  • The purpose is to evaluate the long-term safety of risankizumab in subjects who completed Sub-study 1, Sub-study 2, or the Phase 2, open-label extension study, Study M15-989. Additional objectives are to further investigate long-term effectiveness and tolerability of risankizumab.

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:

  • Subjects who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
  • Subjects have completed the study M16-006 or M15-991 and have achieved clinical response.
  • Main entry criteria for Study M16-006 and Study M15-991:
    • Males and females aged ≥ 18 to ≤ 80 years of age, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible ≥ 16 to < 18 years of age who meet the definition of Tanner stage 5 development;
    • Moderately to severely active CD, defined as average daily SF ≥ 4 and/or average daily AP score ≥ 2;
    • Endoscopic evidence of mucosal inflammation (Simple Endoscopic Score for CD [SES-CD], excluding the presence of narrowing component, ≥ 3 as confirmed by a centrally read endoscopy. During the COVID-19 pandemic the final endoscopy post-induction treatment may not be conducted due to local regulation prohibiting endoscopy and subjects may be allowed to enroll in SS 3 should they meet clinical response.
  • Main entry criteria for all other subjects:
    • Patients with Crohn's disease, who have successfully completed another AbbVie risankizumab Crohn's disease study.

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 Studies M16-006, M15-991 or M15-989 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 Studies M16-006, M15-991 or M15-989.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
  • 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
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