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

• Register: EUCTR
• Last refreshed on: 28 June 2021
• Main ID: EUCTR2016-003123-32-DE
• Date of registration: 19/07/2017
• Prospective Registration: Yes
• 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease
• Date of first enrolment: 09/01/2018
• Target sample size: 855
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003123-32
• 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, 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: 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 at Baseline
- 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 conventional or 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: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 821
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

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 Prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
- Prior exposure to 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

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 infusion
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 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/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: 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

Primary Outcome(s)

Main Objective: The objective of Study M16-006 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

Primary end point(s): Co-Primary Endpoints:
Proportion of subjects with clinical remission at Week 12
Proportion of subjects with endoscopic response at Week 12.

Secondary Objective: Not applicable

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

Secondary Outcome(s)

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

Secondary end point(s): 1. Proportion of subjects with CDAI clinical remission at Week 12
2. Proportion of subjects with CDAI clinical response at Week 4
3. Proportion of subjects with clinical remission at Week 4
4. Proportion of subjects with CDAI clinical response at Week 12
5. Mean change from baseline of induction in FACIT fatigue at Week 12
6. Mean change from baseline of induction in IBDQ total score at Week 12
7. Proportion of subjects with enhanced clinical response and endoscopic response at Week 12
8. Proportion of subjects with endoscopic remission at Week 12
9. Proportion of subjects with enhanced clinical response at Week 4
10. Proportion of subjects with ulcer-free endoscopy at Week 12
11. Enhanced clinical response at Week 12
12. Proportion of subjects with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with any EIMs at Baseline
13. Proportion of subjects with CD-related hospitalization through Week 12
14. Proportion of subjects without draining fistulas at Week 12 in subjects with draining fistulas at Baseline

Secondary ID(s)

M16-006

2016-003123-32-SK

Source(s) of Monetary Support

AbbVie.Inc.

Ethics review

Status: Approved
Approval date: 09/01/2018
Contact: