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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 March 2023
• Main ID: NCT03105102
• Date of registration: 04/04/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
• Date of first enrolment: April 9, 2018
• Target sample size: 1336
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03105102
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

American Samoa, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants who have entered and completed Study M16-006 or Study M15-991 or other
AbbVie risankizumab Crohn's disease study.

- Participants have completed the study M16-006 or M15-991 and have achieved clinical
response.

- Sub-Study 4:

- Participants receiving maintenance treatment in Sub-study 3 and willing to comply
with the requirements of Sub-study 4, including self-administration of
sub-cutaneous injections using the on-body injector (OBI).

- Participant has received at least 16 weeks of stable dosing with risankizumab in
Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the
72-week mark).

Exclusion Criteria:

- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia
or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie
risankizumab Crohn's disease study if the final endoscopy was performed prior to enter
Study M16-000 OR is considered by the Investigator, for any reason, to be an
unsuitable candidate for the study.

- Participant who has a known hypersensitivity to risankizumab or the excipients of any
of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an
adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab
Crohn's disease study that in the Investigator's judgment makes the participant
unsuitable for this study.

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

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

- Any active or chronic recurring infections based on the Investigator's assessment
makes the participant an unsuitable candidate for the study.



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Placebo for Risankizumab SC

Drug: Placebo for Risankizumab IV

Drug: Risankizumab On-Body Injector (OBI)

Drug: Risankizumab SC

Drug: Risankizumab IV

Primary Outcome(s)

Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [Time Frame: Week 52]

Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration [Time Frame: Up to Week 16]

Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16 [Time Frame: Up to Week 16]

Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16 [Time Frame: Up to Week 16]

Sub-Study 1: Percentage of Participants With Endoscopic Response [Time Frame: Week 52]

Sub-Study 3: Number of Participants With Adverse Events [Time Frame: Up to Week 220]

Sub-Study 4: Percentage of Participants who had no Potential Hazards [Time Frame: Up to Week 16]

Secondary Outcome(s)

Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Clinical Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline [Time Frame: Week 52]

Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Endoscopic Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52 [Time Frame: Up to Week 52]

Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0 [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Deep Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission [Time Frame: Week 52]

Secondary ID(s)

M16-000

2016-003191-50

Source(s) of Monetary Support

Please refer to primary and secondary sponsors