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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8 October 2021 |
Main ID: |
EUCTR2016-003190-17-CZ |
Date of registration:
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19/07/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.
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Scientific title:
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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment |
Date of first enrolment:
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02/10/2017 |
Target sample size:
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579 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003190-17 |
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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Denmark
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Egypt
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Estonia
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Finland
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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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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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Slovenia
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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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Turkey
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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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EU 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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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Name:
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EU 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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eu-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: - Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 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 - 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 Are the trial subjects under 18? yes Number of subjects for this age range: 18 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 543 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
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
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 infusion INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre 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: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre 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 injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection/infusion 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: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 12
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Main Objective: 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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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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Secondary Objective: Not applicable.
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Secondary Outcome(s)
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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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Secondary end point(s): 1. Proportion of participants with enhanced clinical response at Week 4, defined as decrease in average daily SF and/or decrease in average daily AP score and/or clinical remission per average daily SF and average daily AP score 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, defined as defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score 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 defined as decrease in average daily SF and/or decrease in average daily AP score and endoscopic response defined as decrease from Baseline in SES-CD at Week 12 6. Proportion of participants with endoscopic healing, assessed using SES-CD, 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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Secondary ID(s)
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M15-991
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NCT03104413
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2016-003190-17-SK
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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: 02/10/2017
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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