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EUCTR2016-004676-22

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Data source: WHO (Imported from 02.08.2020)
Changed: 02.08.2020
Disease category:

Health conditions (Data source: WHO)

Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Interventions (Data source: WHO)


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

Inclusion/Exclusion Criteria (Data source: WHO)

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. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, subjects may be allowed to enroll in Sub-study 3 should they meet clinical response per Partial Adapted Mayo Score.

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.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004676-22

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-004676-22-PT

Further information on trial

Date trial registered

02.07.2018

Incorporation of the first participant

16.07.2018

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

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: 6

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: Sub-study 1: Randomized, double-blind, placebo-controlled maintenance
To evaluate efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) responded to IV risankizumab induction treatment in Study M16-067 or M16-065.
Sub-study 2: Randomized, exploratory maintenance
To evaluate 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 responded to induction treatment in Study M16-067 or M16-065.
Sub-study 3: Open-label long term extension
To evaluate long-term safety of risankizumab in subjects completed Sub-study 1 or 2 or subjects responded to induction treatment in study M16-067 with no final endoscopy due to COVID-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.;Secondary Objective: Not applicable;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;Timepoint(s) of evaluation of this end point: Week 52

Secundary end point (Data source: WHO)

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.


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

Contact information (Data source: WHO)

AbbVie Inc

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall
AbbVie Ltd
+441628561090
eu-clinical-trials@abbvie.com

Contact for scientific information (Data source: WHO)

EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall
AbbVie Ltd
+441628561090
eu-clinical-trials@abbvie.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

AbbVie Deutschland GmbH & Co. KG

Further trial identification numbers

Secondary ID (Data source: WHO)

M16-066
2016-004676-22-BE