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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: ClinicalTrials.gov
Last refreshed on: 20 May 2019
Main ID:  NCT03105102
Date of registration: 04/04/2017
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
Scientific title: 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 Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
Date of first enrolment: April 9, 2018
Target sample size: 912
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03105102
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
American Samoa Argentina Australia Austria Belarus Belgium Bosnia and Herzegovina Brazil
Bulgaria Canada Chile China Colombia Croatia Czechia 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 Romania Russian Federation Serbia
Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Turkey
Ukraine United Kingdom United States
Contacts
Name:     ABBVIE CALL CENTER
Address: 
Telephone: 847.283.8955
Email: abbvieclinicaltrials@abbvie.com
Affiliation: 
Name:     AbbVie Inc.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who have entered and completed Study M16-006 or Study M15-991 or Study
M15-989.

- Subjects have completed the study M16-006 or M15-991 and have achieved clinical
response.

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.

- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study
M15-991 or Study M15-989.

- 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: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: placebo for risankizumab IV
Drug: placebo for risankizumab SC
Drug: risankizumab IV
Drug: risankizumab SC
Primary Outcome(s)
Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52 [Time Frame: Week 52]
Percentage of participants with endoscopic response at Week 52 [Time Frame: Week 52]
Secondary Outcome(s)
36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [Time Frame: Week 0, Week 52]
Crohn's Symptoms Severity (CSS): Change from week 0 to week 52 [Time Frame: Week 0, Week 52]
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [Time Frame: Week 0, Week 52]
Percentage of participants who discontinued corticosteroid use at Week 52 [Time Frame: Week 52]
Percentage 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 [Time Frame: Week 52]
Percentage of participants with clinical remission per average daily SF and average daily AP score and endoscopic response at Week 52 [Time Frame: Week 52]
Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52 [Time Frame: Week 52]
Percentage of participants with Crohn's disease (CD)-related surgeries through Week 52 [Time Frame: 52 weeks]
Percentage of participants with deep remission at Week 52 [Time Frame: Week 52]
Percentage of participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study [Time Frame: Week 52]
Percentage of participants with endoscopic healing at Week 52 [Time Frame: Week 52]
Percentage of participants with enhanced clinical response at Week 52 [Time Frame: Week 52]
Percentage of participants with hospitalizations through Week 52 [Time Frame: 52 weeks]
Percentage of participants with resolution of extra-intestinal manifestations (EIMs) at week 52 in subjects with EIMs at baseline of the induction study [Time Frame: Week 52]
Percentage of participants with sustained clinical remission [Time Frame: Week 0, Week 52]
Percentage of subjects with endoscopic remission at Week 52 [Time Frame: Week 52]
Secondary ID(s)
2016-003191-50
M16-000
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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