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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ClinicalTrials.gov |
Last refreshed on:
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26 July 2021 |
Main ID: |
NCT03105128 |
Date of registration:
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04/04/2017 |
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 Participants 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 of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease |
Date of first enrolment:
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May 10, 2017 |
Target sample size:
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931 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03105128 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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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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China
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Colombia
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Croatia
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Czechia
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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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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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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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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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ABBVIE INC. |
Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: placebo for risankizumab
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Drug: risankizumab IV
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Drug: risankizumab SC
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Primary Outcome(s)
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Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
[Time Frame: Week 12]
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Percentage of Participants With Endoscopic Response
[Time Frame: Week 12]
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Secondary Outcome(s)
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Percentage of Participants With CD-Related Hospitalization
[Time Frame: Up to Week 12]
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Percentage of Participants With Endoscopic Remission
[Time Frame: Week 12]
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Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
[Time Frame: Week 4]
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Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
[Time Frame: Up to Week 12]
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Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
[Time Frame: Week 12]
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Percentage of Participants With Stool Frequency (SF) Remission
[Time Frame: Week 12]
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Percentage of Participants With Ulcer-Free Endoscopy
[Time Frame: Week 12]
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Percentage of Participants With Clinical Remission
[Time Frame: Week 12]
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Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
[Time Frame: Week 12]
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Percentage of Participants With Abdominal Pain (AP) Remission
[Time Frame: Week 12]
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Percentage of Participants With CDAI Clinical Response and Endoscopic Response
[Time Frame: Week 12]
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Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline
[Time Frame: Week 12]
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Percentage of Participants With Enhanced Clinical Response
[Time Frame: Up to Week 12]
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Secondary ID(s)
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2016-003123-32
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M16-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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