Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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9 October 2023 |
Main ID: |
EUCTR2016-003191-50-DK |
Date of registration:
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18/07/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
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Scientific title:
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A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease |
Date of first enrolment:
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19/07/2017 |
Target sample size:
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1250 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003191-50 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belarus
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Belgium
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Czechia
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Denmark
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Egypt
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Estonia
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France
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Germany
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Greece
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Hong Kong
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Hungary
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Latvia
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Lithuania
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Puerto Rico
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Global Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+44 1628 561090 |
Email:
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global-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Name:
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Global Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+44 1628 561090 |
Email:
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global-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Entry and completion of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study. The final endoscopy for studies M16-006 and M15-991 may be missing during the coronavirus SARS-CoV-2 pandemic due to local regulations prohibiting endoscopy and subjects may be allowed to enroll in Sub-study 3 should they meet clinical response. 2. Achieved clinical response, defined as = 30% decrease in average daily SF and/or = 30% decrease in average daily AP score, and both not worse than Baseline of the induction study, at the last visit of Study M16-006 or Study M15-991. This is not applicable for subjects enrolling from another AbbVie risankizumab Crohn's disease study. 3. If female, subject must meet the criteria as stated in protocol Contraception Recommendations. 4. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol, including self-administration or care giver administration of SC injections (if allowed per local requirements).
Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria: Subjects should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter M16-000 or 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 Study M16 006 , Study M15-991 or another AbbVie risankizumab Crohn's disease study 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 Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
Confirmed positive urine pregnancy test at the Final Visit of Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
Subject with any active or chronic recurring infections based on the Investigator's assessment makes the subject an unsuitable candidate for the study.
Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Crohn's disease MedDRA version: 20.0
Level: LLT
Classification code 10013099
Term: Disease Crohns
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 52 Week 52
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Secondary Objective: Not applicable
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Main Objective: SS 1:Randomized, double-blind, placebo-controlled maintenance Evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with Crohn's disease (CD) who responded to risankizumab treatment in Study M16-006 or M15-991 and had a Baselineeligibility SES-CD of = 6 (= 4 for isolated ileal disease). SS 2:Randomized, exploratory maintenance Evaluate the efficacy and safety of two different regimens for risankizumab as therapy in subjects with CD who responded to treatment in Study M16-006 or Study M15-991. SS 3:Open-label long term extension Evaluate long-term safety of risankizumab in subjects and to further investigate long-term efficacy and tolerability of risankizumab. CTE: (OL) To provide SS 3 completers with uninterrupted treatment of risankizumab until commercially available and/or the subject can receive treatment locally or transition to a separate study and to continue to investigate and evaluate longterm safety data for risankizumab.
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Primary end point(s): Proportion of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52.
Proportion of participants with endoscopic response at Week 52.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: All are Week 52
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Secondary end point(s): 1. Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52 2. Proportion of subjects with clinical remission at Week 52 among the subjects with clinical remission in Week 0 3. Proportion of subjects with ulcer-free endoscopy at Week 52 4. Proportion of subjects with endoscopic remission at Week 52 5. Mean change of IBDQ total score at Week 52 from baseline of induction 6. Mean change of FACIT fatigue at Week 52 from baseline of induction 7. Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction). 8. Proportion of subjects with CDAI clinical response at Week 52 9. Proportion of subjects with clinical remission and endoscopic response at Week 52 10. Proportion of subjects with enhanced clinical response at Week 52 11. Proportion of subjects with deep remission at Week 52 12. Exposure adjusted occurrence of CD-related hospitalizations from Week 0 through Week 52 13. Change from baseline of the induction study in Short Form-36 (SF-36) Physical Component Summary score at Week 52
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Secondary ID(s)
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2016-003191-50-SK
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M16-000
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Source(s) of Monetary Support
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AbbVie.Inc.
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Ethics review
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Status: Approved
Approval date: 29/06/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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