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

• Register: EUCTR
• Last refreshed on: 3 October 2023
• Main ID: EUCTR2016-003191-50-PL
• Date of registration: 03/08/2017
• 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
• 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
• Target sample size: 1250
• Recruitment status: NA
• 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, Finland, 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 risaknizumab 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 Substudy 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 from another Abbvie risaknizumab Crohn's disease study.
3. If female, subject must meet the criteria as stated in protocol Contraception Recommendations.
4. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol, including self-administration or care giver administration of SC injections (if allowed per local requirements).
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:
Subjects should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991 or another Abbvie risaknizumab Crohn's disease study in the final endoscopy was performed prior to enter M16-000 or 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 risaknizumab 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 risaknizumab Crohn's disease study.

Confirmed positive urine pregnancy test at the Final Visit of Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.

Subject with any active or chronic recurring infections based on the Investigator's assessment makes the subject an unsuitable candidate for the study.

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:
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

Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Risankizumab
CAS Number: 1612838-76-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

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.

Main Objective: Sub-study 1:
Evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with 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).
Sub-study 2:
Evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects with CD who responded to induction treatment in Study M16-006 or Study M15-991.
Sub-study 3: Open-label long term extension
Evaluate long-term safety of risankizumab in subjects and to further investigate long-term efficacy and tolerability of risankizumab.
CTE: (OL)
To provide SS3 completers with uninterrupted treatment of risankizumab until commercially available and /or the subject can receive treatment locally or transition to a separate study and to continue to investigate and evaluate long-term safety data for risankizumab.

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. Exposure adjusted occurrence of CD-related hospitalizations from Week 0 through Week 52
13. Change from baseline of the induction study un Short Form-36 (SF-36) Physical Component Summary at Week 52

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

Secondary ID(s)

M16-000

2016-003191-50-SK

Source(s) of Monetary Support

AbbVie.Inc.