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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2016-004676-22-DK
• Date of registration: 02/05/2018
• 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
• 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
• Date of first enrolment: 15/11/2018
• Target sample size: 760
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004676-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes 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: 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, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, 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:
Entry and completion of Study M16-067 or Study M16-065. Completion includes the final endoscopy of Study M16-067 or Study M16-065.

Achieved clinical response at the last visit of Study M16-067 or Study M16-065.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
Subject 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 Study M16-067 or Study M16-065 that in the Investigator's judgment makes the subject unsuitable for this study.



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

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

Intervention(s)

Product Name: Risankizumab
Product Code: ABBV-006
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)

Main Objective: Study M16-066 comprises three sub-studies:
Sub-study 1: Randomized, double-blind, placebo-controlled maintenance
To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) who responded to IV risankizumab induction treatment in Study M16-067 or Study M16-065.
Sub-study 2: Randomized, exploratory maintenance
To evaluate the efficacy and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active UC who responded to induction treatment in Study M16-067 or Study M16-065.
Sub-study 3: Open-label long term extension
To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.

Primary end point(s): Sub-study 1 or 2 : Proportion of subjects with clinical remission per Adapted Mayo score at Week 52.
Sub-study 3: Evaluation of long-term safety

Secondary Objective:

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

Secondary Outcome(s)

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

Secondary end point(s): 1. Proportion of subjects with endoscopic improvement at Week 52.
2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 52.
3. Proportion of subjects with steroid-free remission at Week 52.
4. Proportion of subjects with sustained clinical remission per Adapted Mayo score at Week 52.
5. Proportion of subjects who discontinued corticosteroid use at Week 52.
6. Proportion of subjects with sustained endoscopic improvement at Week 52.
7. Proportion of subjects with clinical response per Adapted Mayo score at Week 52.
8. Proportion of subjects with endoscopic remission at Week 52.
9. Proportion of subjects with hospitalizations through Week 52.
10. Change from Baseline in UC-Symptom Questionnaire (UCSQ) at Week 52.
11. Proportion of subjects with histologic remission at Week 52.
12. Proportion of subjects with mucosal healing at Week 52.
13. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 52.
14. Proportion of subjects with UC-related surgeries through Week 52.
15. Change from Baseline in Short Form-36 at Week 52.
16. Change from Baseline in FACIT-Fatigue at Week 52.

Secondary ID(s)

M16-066

2016-004676-22-BE

Source(s) of Monetary Support

AbbVie Inc

Ethics review

Status: Approved
Approval date:
Contact: