Phase 3
Completed N=931
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Crohn's Disease
Source: ClinicalTrials.gov NCT03105128 ↗
Enrolled (actual)
931
Serious AEs
6.2%
Results posted
Jul 2022
Primary outcomePrimary: US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission — 24.6; 45.2; 41.6 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
6citations · ~3 / year
Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies.
Summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Linked Publications (5)
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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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Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment.
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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.
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Content Validity and Psychometric Evaluation of the Crohn's Symptom Severity (CSS) Questionnaire 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 |
10.3; 18.4; 18.9 | 0.015 sig |
| PRIMARY US Specific: Percentage of Participants With Endoscopic Response |
12.0; 40.3; 32.1 | <0.001 sig |
| PRIMARY Global Outside of US: Percentage of Participants With Clinical Remission |
9.1; 21.0; 21.2 | <0.001 sig |
| PRIMARY Global Outside of US: Percentage of Participants With Endoscopic Response |
12.0; 40.3; 32.1 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Clinical Remission |
21.7; 43.5; 41.0 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
36.7; 59.7; 64.9 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
36.7; 59.7; 64.9 | <0.001 sig |
| SECONDARY US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue |
6.0; 11.2; 10.1 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission |
10.3; 18.4; 18.9 | 0.015 sig |
| SECONDARY US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response |
5.7; 30.0; 23.0 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Stool Frequency (SF) Remission |
29.8; 54.2; 54.0 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Abdominal Pain (AP) Remission |
38.5; 59.6; 58.1 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Endoscopic Remission |
9.1; 24.2; 23.9 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Enhanced Clinical Response |
41.9; 62.8; 64.3 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Ulcer-Free Endoscopy |
7.6; 21.0; 16.4 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Enhanced Clinical Response |
41.9; 62.8; 64.3 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at |
20.5; 38.1; 43.7 | 0.022 sig |
| SECONDARY US Specific: Percentage of Participants With CD-Related Hospitalization |
12.0; 3.3; 1.8 | <0.001 sig |
| SECONDARY US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline |
22.2; 27.8; 29.2 | 1.00 |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission |
24.6; 45.2; 41.6 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
36.7; 59.7; 64.9 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Clinical Remission |
9.1; 21.0; 21.2 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response |
36.7; 59.7; 64.9 | <0.001 sig |
| SECONDARY Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue |
6.0; 11.2; 10.1 | <0.001 sig |
| SECONDARY Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
23.6; 44.3; 43.0 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response |
8.0; 30.9; 23.2 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Endoscopic Remission |
9.1; 24.2; 23.9 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response |
41.9; 62.8; 64.3 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy |
7.6; 21.0; 16.4 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Enhanced Clinical Response |
41.9; 62.8; 64.3 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline |
20.5; 38.1; 43.7 | 0.022 sig |
| SECONDARY Global Outside of US: Percentage of Participants With CD-Related Hospitalization |
12.0; 3.3; 1.8 | <0.001 sig |
| SECONDARY Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline |
22.2; 27.8; 29.2 | 1.000 |
| SECONDARY Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment |
-8.344; -17.930; -20.485 | 0.024 sig |
| SECONDARY Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score |
5.482; 8.394; 8.756 | <0.001 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.
- Diagnosis of CD for at least 3 months prior to 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 conventional or 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 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 (NCT03105128) 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.