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

• Register: EUCTR
• Last refreshed on: 17 May 2021
• Main ID: EUCTR2016-003191-50-AT
• Date of registration: 31/07/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public 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
• 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
• Date of first enrolment: 03/08/2017
• Target sample size: 1250
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003191-50
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, 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, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Global Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: Global Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

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 another AbbVie risankizumab Crohn's disease study.
3. If female, subject must meet the criteria as stated in protocol
Contraception Recommendations.
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:
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 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 Studies M16-006, M15-991 or another
AbbVie risankizumab Crohn's disease study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's disease
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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

Primary Outcome(s)

Main Objective: SS1: 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 and had a Baseline (of induction) eligibility SES-CD of = 6 (= 4 for isolated ileal disease).
SS2: 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 M15-991.
SS3: Open-label long term extension
Evaluate long-term safety of Risankizumab in subjects who completed SS1,2, or subjects who enroll directly into SS3(from either induction studies or another AbbVie risankizumab CD study). Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Week 52

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.

Secondary Outcome(s)

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. Proportion of subjects with resolution of EIMs at Week 52 in subjects with any EIMs at baseline of induction
13. Proportion of subjects with CD-related hospitalizations through
Week 52
14. Proportion of subjects without draining fistulas at Week 52 in
subjects with draining fistulas at baseline of induction
15.Proportion of subjects with CD-related surgeries through Week 52

Timepoint(s) of evaluation of this end point: All are Week 52

Secondary ID(s)

2016-003191-50-SK

M16-000

Source(s) of Monetary Support

AbbVie.Inc.

Ethics review

Status: Approved
Approval date: 12/07/2017
Contact: