A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT03104413
• Date of registration: 04/04/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
• Date of first enrolment: December 18, 2017
• Target sample size: 618
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03104413
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• 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, Hungary, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
local regulations, at the Baseline Visit. Where locally permissible, participants 16
to < 18 years of age who meet the definition of Tanner stage 5 for development at the
Baseline Visit.

- Confirmed diagnosis of CD for at least 3 months prior to Baseline.

- Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

- Demonstrated intolerance or inadequate response to biologic therapy for CD.

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

- Participants with unstable doses of concomitant Crohn's disease therapy.

- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
within 12 weeks prior to Baseline), or any investigational biologic or other agent or
procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
longer.

- Prior exposure to p19 inhibitors (e.g., risankizumab).

- Complications of Crohn's disease.

- Having an ostomy or ileoanal pouch.

- Known active Coronavirus Disease 2019 (COVID-19) infection.



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 IV

Drug: risankizumab IV

Drug: risankizumab SC

Primary Outcome(s)

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [Time Frame: Week 12]

Percentage of Participants With Endoscopic Response [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants With CDAI Clinical Response and Endoscopic Response [Time Frame: Week 12]

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [Time Frame: Week 4]

Percentage of Participants With Endoscopic Remission [Time Frame: Week 12]

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [Time Frame: Up to Week 12]

Percentage of Participants With Ulcer-Free Endoscopy [Time Frame: Week 12]

Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [Time Frame: Week 12]

Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [Time Frame: Week 12]

Percentage of Participants With Enhanced Clinical Response [Time Frame: Up to Week 12]

Percentage of Participants With Abdominal Pain (AP) Remission [Time Frame: Week 12]

Percentage of Participants With Clinical Remission [Time Frame: Up to Week 12]

Percentage of Participants With CD-Related Hospitalization [Time Frame: Up to Week 12]

Percentage of Participants With Stool Frequency (SF) Remission [Time Frame: Week 12]

Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline [Time Frame: Week 12]

Secondary ID(s)

2016-003190-17

M15-991

Source(s) of Monetary Support

Please refer to primary and secondary sponsors