A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

• Register: EUCTR
• Last refreshed on: 16 December 2024
• Main ID: EUCTR2016-004677-40-IT
• Date of registration: 20/01/2022
• 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 Who Have Failed Prior Biologic Therapy
• 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 Who Have Failed Prior Biologic Therapy - na
• Target sample size: 720
• Recruitment status: Not Recruiting
• 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: 15
• 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, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, 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:
1.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
2.Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
3. Active UC.
4.Demonstrated intolerance or inadequate response to one or more biologic therapies.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 660
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
1.Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation or ischemic colitis.
2.Subject receiving prohibited medications and treatment.
3.Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
4.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: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

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
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
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

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

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 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

Secondary end point(s): 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 12.

Secondary ID(s)

2016-004677-40-BE

M16-067

M16-067

Source(s) of Monetary Support

AbbVie Inc

Results

• Results available: Yes
• Date Posted: 25/05/2024
• Date Completed: 11/05/2023
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004677-40/results