A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 23 November 2020
• Main ID: EUCTR2016-004677-40-DK
• Date of registration: 12/06/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: 28/06/2018
• Target sample size: 1547
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004677-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, 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, or minimum age of adult consent according to local regulations at the Baseline Visit. In addition for sub-study 2 only: Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
- Active UC.
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators, and/or biologic therapies
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1467
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation or ischemic colitis.
- Subject receiving prohibited medications and treatment.
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- Subject with currently known complications of UC.


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

Health Condition(s) or Problem(s) studied

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

Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: 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
Current Sponsor code: ABBV-066
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)

Primary end point(s): Proportion of subjects with clinical remission per Adapted Mayo score at Week 12.

Main Objective: Study M16-067 comprises two sub-studies:
The objective of Sub-Study 1 are to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.
The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

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

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): Sub-study 1
1. Proportion of subjects with endoscopic improvement at Week 12.
2. Proportion of subjects achieving clinical remission at Week 12 in subjects with a Full Mayo score of 6 to 12 at Baseline.
3. Proportion of subjects achieving clinical response at Week 12.
4. Proportion of subjects achieving clinical response at Week 4.
5. Proportion of subjects with endoscopic remission at Week 12.
6. Proportion of subjects with hospitalizations through Week 12.
7. Proportion of subjects with mucosal healing at Week 12.
8. Change from Baseline in UC-Symptom Questionnaire (UC-SQ) at Week 12.
9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12.
10. Change from Baseline in Short Form-36 at Week 12.
11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) at Week 12.
12. Proportion of subjects with UC-related surgeries through Week

Sub-study 2
1. Proportion of subjects achieving clinical remission per Full Mayo score at Week 12 in subjects with a Full Mayo score of 6 to 12 at
Baseline
2. Proportion of subjects achieving clinical response per Adapted Mayo score at Week 12
3. Proportion of subjects achieving clinical response per Partial Adapted Mayo score at Week 4
4. Proportion of subjects who reported no abdominal pain at Week 12
5. Proportion of subjects who reported no bowel urgency at Week 12
6. Proportion of subjects with endoscopic remission at Week 12
7. Proportion of subjects with endoscopic improvement at Week 12
8. Change from Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
9. Change from Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
10. Proportion of subjects with histological endoscopic improvement of the mucosa at Week 12
11. Proportion of subjects who reported no nocturnal bowel movements at Week 12
12. Proportion of subjects who reported no tenesmus at Week 12
13. Change from Baseline to Week 12 in number of fecal incontinence episodes per week
14. Change from Baseline to Week 12 in number of days per week with sleep interrupted due to UC symptoms
15. Proportion of subjects achieving clinical response per Adapted Mayo score at Week 12 in subjects with pancolitis at Baseline
16. Proportion of subjects with UC-related hospitalizations through Week 12
17. Change from Baseline to Week 12 in Short Form-36 (SF-36)

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

Sub-study 2
1. Week 12
2. Week 12
3. Week 4
4. Week 12
5. Week 12
6. Week 12
7. Week 12
8. Week 12
9. Week 12
10. Week 12
11. Week 12
12. Week 12
13. Week 12
14. Week 12
15. Week 12
16. Week 12
17. Week 12

Secondary ID(s)

2016-004677-40-BE

M16-067

Source(s) of Monetary Support

AbbVie Inc

Ethics review

Status: Approved
Approval date: 28/06/2018
Contact: