Phase 3
Completed N=618
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
Crohn's Disease
Source: ClinicalTrials.gov NCT03104413 ↗
Enrolled (actual)
618
Serious AEs
6.6%
Results posted
Jun 2022
Primary outcomePrimary: US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission — 19.8; 42.0; 40.3 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
13citations · ~4 / year
Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.
Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Linked Publications (5)
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Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.
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Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies.
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Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease.
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Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.
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Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission |
11.2; 20.9; 19.4 | 0.010 sig |
| PRIMARY US Specific: Percentage of Participants With Endoscopic Response |
11.2; 28.8; 34.2 | < 0.001 sig |
| PRIMARY Global Outside of US: Percentage of Participants With Clinical Remission |
8; 17.3; 18.3 | 0.006 sig |
| PRIMARY Global Outside of US: Percentage of Participants With Endoscopic Response |
19.3; 34.6; 39.8 | 0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Clinical Remission |
19.3; 34.6; 39.8 | 0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
30.0; 59.5; 60.7 | < 0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
30.0; 59.5; 60.7 | < 0.001 sig |
| SECONDARY US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue |
7.7; 10.5; 10.8 | 0.020 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission |
11.2; 20.9; 19.4 | 0.010 sig |
| SECONDARY US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response |
5.3; 20.5; 23.0 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Stool Frequency (SF) Remission |
28.3; 46.1; 48.7 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Abdominal Pain (AP) Remission |
36.4; 58.1; 59.2 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Endoscopic Remission |
4.3; 19.4; 20.4 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Enhanced Clinical Response |
39.1; 61.8; 59.2 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Ulcer-Free Endoscopy |
4.3; 13.8; 15.4 | 0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Enhanced Clinical Response |
39.1; 61.8; 59.2 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline |
23.7; 29.5; 37.1 | 0.377 |
| SECONDARY US Specific: Percentage of Participants With CD-Related Hospitalization |
11.2; 3.1; 2.1 | 0.002 sig |
| SECONDARY US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline |
13.3; 7.1; 43.8 | 1 |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission |
19.8; 42; 40.3 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
30.0; 59.5; 60.7 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Clinical Remission |
8; 17.3; 18.3 | 0.006 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
30.0; 59.5; 60.7 | <0.001 sig |
| SECONDARY Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue |
7.7; 10.5; 10.8 | 0.020 sig |
| SECONDARY Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
27.2; 39.6; 42.2 | 0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response |
7; 21; 24.1 | <0.001 sig |
| SECONDARY Global Outside of US:: Percentage of Participants With Endoscopic Remission |
4.3; 19.4; 20.4 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response |
39.1; 61.8; 59.2 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy |
4.3; 13.8; 15.4 | 0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response |
39.1; 61.8; 59.2 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline |
23.7; 29.5; 37.1 | 0.377 |
| SECONDARY Global Outside of US: Percentage of Participants With CD-Related Hospitalization |
11.2; 3.1; 2.1 | 0.002 sig |
| SECONDARY Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline |
13.3; 7.1; 43.8 | 1.00 |
| SECONDARY Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment |
-12.253; -19.576; -21.013 | 0.113 |
| SECONDARY Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score |
5.237; 7.458; 7.951 | 0.008 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03104413) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.