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 |
Sub-study 1: Randomized, double-blind, placebo-controlled maintenance To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.
Sub-study 2: Randomized, exploratory maintenance To evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.
Sub-study 3: Open-label long term extension To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2 or M15-989 |
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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 |
Subjects who have completed Study M16-006 or Study M15-991 and have achieved clinical response or completion of M15-989.
Main entry criteria for Study M16-006 and Study M15-991: • Males and females 18 to 80 years of age • 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) for at least 3 months prior to Baseline. |
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E.4 | Principal exclusion criteria |
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16 006 , M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52.
Percentage of participants with endoscopic response at Week 52. |
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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 clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52 2. Proportion of participants who discontinued corticosteroid use for 90 days and achieved clinical remission per average daily SF and average daily AP score at Week 52 3. Proportion of participants who discontinued corticosteroid use at Week 52 4. Proportion of participants with sustained clinical remission 5. Proportion of participants with enhanced clinical response at Week 52 6. Proportion of participants with clinical remission and endoscopic response at Week 52 7. Proportion of participants with endoscopic healing at Week 52 8. Proportion of participants with endoscopic remission at Week 52 9. Proportion of subjects with resolution of EIMs at Week 52 10. Proportion of subjects with deep remission at Week 52 11. Proportion of participants with hospitalizations through Week 52 12. Proportion of participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study 13. Change from Week 0 in FACIT-Fatigue at Week 52 14. Change from Week 0 in short form-36 at Week 52 15. Proportion of subjects with CD-related surgeries through Week 52 16. Crohn's Symptoms Severity (CSS): Change from week 0 to week 52 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All are Week 52 unless noted: sustained clinical remission and CSS are at Week 0 and Week 52 and the FACIT and SF-36 are from Baseline of induction study and Week 52 |
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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 | 160 |
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 |
Japan |
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 | 8 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |