A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

• Register: EUCTR
• Last refreshed on: 18 October 2021
• Main ID: EUCTR2016-003190-17-LV
• Date of registration: 01/08/2017
• Prospective Registration: No
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
• Date of first enrolment: 31/07/2017
• Target sample size: 579
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003190-17
• 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, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, 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:
- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 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
- Crohn's disease activity index (CDAI) score 220-450 during the screening period
- 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 biologic therapy for CD
- If female, subject must meet the contraception recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 543
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion criteria:
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
- Subjects with unstable doses of concomitant Crohn’s disease therapy
- Receipt of Crohn’s disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
- Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab)
- Complications of Crohn’s disease (strictures, stenosis, short bowel, etc)
- Having an ostomy or ileoanal pouch


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

Health Condition(s) or Problem(s) studied

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

Crohn's disease
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000016693

Intervention(s)

Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
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: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
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 injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection/infusion 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: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Objective: Not applicable.

Primary end point(s): Co-Primary Endpoints:
Proportion of participants with clinical remission (per daily stool frequency [SF] and average daily abdominal pain [AP] score) at Week 12 and percentage of participants with endoscopic response at Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Week 4
2. Week 12
3. Week 12
4. Week 4
5. Week 12
6. Week 12
7. Week 12
8. Week 12
9. 12 weeks
10. Week 12
11. Baseline, Week 12
12. Baseline, Week 12
13. 12 weeks

Secondary end point(s): 1. Proportion of participants with enhanced clinical response at Week 4, defined as decrease in average daily SF and/or decrease in average daily AP score and/or clinical remission per average daily SF and average daily AP score
2. Proportion of participants with clinical remission per Crohn's disease activity index (CDAI) at Week 12
3. Proportion of participants with enhanced clinical response at Week 12, defined as defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score
4. Proportion of participants with clinical remission per average daily SF and average daily AP score at Week 4
5. Proportion of participants with enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score and endoscopic response defined as decrease from Baseline in SES-CD at Week 12
6. Proportion of participants with endoscopic healing, assessed using SES-CD, at Week 12
7. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12
8. Proportion of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline
9. Proportion of participants with hospitalization through Week 12
10. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline
11. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12
12. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12
13. Proportion of participants with Crohn's disease (CD)-related surgeries through Week 12

Secondary ID(s)

NCT03104413

2016-003190-17-SK

M15-991

Source(s) of Monetary Support

AbbVie.Inc.

Ethics review

Status: Approved
Approval date: 31/07/2017
Contact: