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: 28 February 2019
• Main ID: EUCTR2016-003191-50-LV
• Date of registration: 25/07/2017
• 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 Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989
• Date of first enrolment: 18/08/2017
• Target sample size: 959
• 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, 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, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who have completed Study M16-006 or Study M15-991 and have achieved clinical response or completion of M15-989.

Main entry criteria for Study M16-006 and Study M15-991:
• Males and females 18 to 80 years of age, and 16 to < 18 years of age where locally permitted and who meet the definition of Tanner stage 5 development (M16-006 only)
• 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) for at least 3 months prior to Baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 899
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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


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

Primary Outcome(s)

Main Objective: Sub-study 1: 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.

Sub-study 2: 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 Study M15-991.

Sub-study 3: Open-label long term extension
To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2 or M15-989

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

Primary end point(s): Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52.

Percentage of participants with endoscopic response at Week 52.

Secondary Objective: Not applicable

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 participants who discontinued corticosteroid use for 90 days and achieved clinical remission per average daily SF and average daily AP score at Week 52
3. Proportion of participants who discontinued corticosteroid use at Week 52
4. Proportion of participants with sustained clinical remission
5. Proportion of participants with enhanced clinical response at Week 52
6. Proportion of participants with clinical remission and endoscopic response at Week 52
7. Proportion of participants with endoscopic healing at Week 52
8. Proportion of participants with endoscopic remission at Week 52
9. Proportion of subjects with resolution of EIMs at Week 52
10. Proportion of subjects with deep remission at Week 52
11. Proportion of participants with hospitalizations through Week 52
12. Proportion of participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study
13. Change from Week 0 in FACIT-Fatigue at Week 52
14. Change from Week 0 in short form-36 at Week 52
15. Proportion of subjects with CD-related surgeries through Week 52
16. Crohn's Symptoms Severity (CSS): Change from week 0 to week 52

Timepoint(s) of evaluation of this end point: All are Week 52 unless noted: sustained clinical remission and CSS are at Week 0 and Week 52 and the FACIT and SF-36 are from Baseline of induction study and Week 52

Secondary ID(s)

M16-000

2016-003191-50-SK

Source(s) of Monetary Support

AbbVie.Inc.

Ethics review

Status: Approved
Approval date:
Contact: