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EUCTR2016-004676-22

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Data source: WHO (Imported from 20.03.2024)
Changed: Mar 13, 2024, 1:00 AM
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

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: 60-

Inclusion/Exclusion Criteria (Data source: WHO)

Gender:
Female: yes
Male: yes

Inclusion criteria:
Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16 067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, or due to the geo-political conflict in Ukraine and surrounding impacted regions, subjects may be allowed to enroll in Sub-study 3 should they meet clinical response.

Achieved clinical response at the last visit of Study M16-067.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 894
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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 that in the Investigator's judgment makes the subject unsuitable for this study.

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2016-004676-22
Further information on trial

Date trial registered

Feb 6, 2019

Incorporation of the first participant

May 20, 2019

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

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: 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
Sub-study 2: 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
Sub-study 3: To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2 or subjects who responded to induction treatment in Study M16-067 with no final endoscopy due to the COVID-19 pandemic or the geo-political conflict in Ukraine and surrounding impacted regions. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.
CTE: Investigate and evaluate long-term safety data for risankizumab;Secondary Objective: Not applicable;Primary end point(s): Sub-study 1 and 2: The achievement of clinical remission per Adapted Mayo score at Week 52
Sub-study 2: Selected efficacy endpoints as those listed in Sub-study 1 but comparing the Therapeutic Drug Monitoring vs Clinical Assessment arms as exploratory purpose.
Sub-study 3: Evaluation of long-term safety
There are no efficacy endpoints for CTE.;Timepoint(s) of evaluation of this end point: Week 52

Secundary end point (Data source: WHO)

Secondary end point(s): 1. The achievement of endoscopic improvement at Week 52.
2. The achievement of histologic endoscopic improvement of the mucosa at Week 52.
3. The achievement of endoscopic remission at Week 52.
4. The achievement of clinical remission per Adapted Mayo score at Week 52 with no corticosteroid use for 90 days.
5. The achievement of clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0.
6. The achievement of no bowel urgency at Week 52
7. The achievement of no abdominal pain at Week 52
8. The achievement of histologic endoscopic mucosal remission at Week 52.
9. The achievement of endoscopic improvement at Week 52 in subjects with endoscopic improvement at Week 0.
10. The achievement of clinical response per Adapted Mayo score at Week 52.
11. Change from Baseline (of induction) to Week 52 in FACIT-Fatigue.
12. Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
13. The achievement of no nocturnal bowel movements at Week 52.
14. The achievement of no tenesmus at Week 52.
15. Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per week
16. Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms.
17. Exposure adjusted Occurrence of UC-related hospitalizations through Week 52;Timepoint(s) of evaluation of this end point: All measured at 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

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, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, 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, T?rkiye, Taiwan, Ukraine, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Global Clinical Trials Contact
Knollstrasse
AbbVie Deutschland GmbH & Co. KG
+496111720 1520
global-clinical-trials@abbvie.com

Contact for scientific information (Data source: WHO)

Global Clinical Trials Contact
Knollstrasse
AbbVie Deutschland GmbH & Co. KG
+496111720 1520
global-clinical-trials@abbvie.com

Further trial identification numbers

Secondary ID (Data source: WHO)

M16-066
2016-004676-22-BE
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