E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013099 |
E.1.2 | Term | Disease Crohns |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female aged >=18 to <= 80 years at the Baseline Visit. - Diagnosis of CD for at least 3 months prior to Baseline - Crohn's disease activity index (CDAI) score 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, subject must meet the contraception recommendations |
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E.4 | Principal exclusion criteria |
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis - Subjects with unstable doses of concomitant Crohn’s disease therapy - Receipt of Crohn’s disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline - Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab) - Complications of Crohn’s disease (strictures, stenosis, short bowel, etc) - Having an ostomy or ileoanal pouch |
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-Primary Endpoints: Proportion of participants with clinical remission (per daily stool frequency [SF] and average daily abdominal pain [AP] score) at Week 12 and percentage of participants with endoscopic response at Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of participants with enhanced clinical response at Week 4 2. Proportion of participants with clinical remission per Crohn's disease activity index (CDAI) at Week 12 3. Proportion of participants with enhanced clinical response at Week 12 4. Proportion of participants with clinical remission per average daily SF and average daily AP score at Week 4 5. Proportion of participants with enhanced clinical response and endoscopic response at Week 12 6. Proportion of participants with endoscopic healing at Week 12 7. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12 8. Proportion of subjects with endoscopic remission at Week 12 9. Proportion of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline 10. Proportion of participants with hospitalization through Week 12 11. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline 12. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 13. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 14. Proportion of participants with Crohn's disease (CD)-related surgeries through Week 12 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 4 2. Week 12 3. Week 12 4. Week 4 5. Week 12 6. Week 12 7. Week 12 8. Week 12 9. Week 12 10. Week 12 11. Week 12 12. Week 12 13. Week 12 14. Week 12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 150 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belarus |
Belgium |
Bosnia and Herzegovina |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Croatia |
Czech Republic |
Denmark |
Egypt |
Estonia |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Ireland |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Puerto Rico |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 15 |