Multicenter, randomized, double-blind, placebo-controlled, 52-week maintenance and open-label extension study of the efficacy and safety of Risankizumab in patients with ulcerative colitis who responded to the induction treatment in study M16 067 or M16 065.
Summary description of the study
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that leads to inflammation and bleeding of the rectal and colonic mucosa (large intestine). Currently, there are various treatment options for patients with UC: including anti-inflammatory drugs (mesalazine or steroids), immunosuppressants (azathioprine), and biologics (medications administered by injection that alter the immune response, e.g., adalimumab, infliximab, vedolizumab), but they are not always effective. Risankizumab is an investigational drug developed for the treatment of patients with inflammatory diseases such as UC. This study investigates how well Risankizumab works and how safe it is compared to placebo (no active ingredient). It is a 52-week maintenance study and an open-label (i.e., the dose is known) long-term extension study in patients with moderate to severe UC who responded to the induction therapy in studies M16 067 and M16 065.
(BASEC)
Intervention under investigation
Approximately 760 participants will be enrolled in the study at 400 study centers worldwide.
In the blinded (i.e., no one knows what the study participant is receiving) sub-study 1, participants will receive Risankizumab or placebo subcutaneously (s.c., i.e., injection under the skin) every 8 weeks for 52 weeks. If needed, participants may receive Risankizumab as emergency therapy.
In sub-study 2, participants will receive placebo intravenously (i.v.) and Risankizumab s.c. or Risankizumab i.v. and placebo s.c. at the first visit. All participants will then receive Risankizumab s.c. at week 8 and, if needed, Risankizumab i.v. as emergency therapy.
All participants who complete sub-studies 1 and 2 may transition to long-term extension study 3 and receive Risankizumab every 8 weeks.
(BASEC)
Disease under investigation
Ulcerative Colitis (UC)
(BASEC)
1. Inclusion in and completion of study M16 067 or M16 065. A final endoscopy is required for completion of study M16 067 or M16 065. 2. Clinical response at the last visit in study M16 067 or M16 065. (BASEC)
Exclusion criteria
1. Patients deemed ineligible for the study by the investigator for any reason. 2. Known hypersensitivity to Risankizumab or the excipients of the study medications or the components of the CHO cell line, or an adverse event (AE) during study M16 067 or M16 065 that the investigator deems renders the patient ineligible for the study. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
AbbVie Inc., North Chicago USA AbbVie AG, Cham
(BASEC)
Contact
Contact Person Switzerland
Franzisca Rusca
+41 41 399 16 89
franzisca.rusca@clutterabbvie.comAbbVie Medical Information
(BASEC)
General Information
AbbVie
(ICTRP)
Scientific Information
AbbVie
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
19.11.2018
(BASEC)
ICTRP Trial ID
NCT03398135 (ICTRP)
Official title (approved by ethics committee)
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 (BASEC)
Academic 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 (ICTRP)
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (ICTRP)
Disease under investigation
Ulcerative Colitis (UC) (ICTRP)
Intervention under investigation
Drug: risankizumab;Drug: placebo for risankizumab (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: 80 Years
Minimum age: 16 Years
Inclusion Criteria:
- Participants who have completed Study M16-067 and have achieved clinical response as
defined in the protocol.
Exclusion Criteria:
- Participants who have a known hypersensitivity to risankizumab or the excipients of
any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an
adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes
the participant unsuitable for this study.
- Participant is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study.
- Participant is not in compliance with prior and concomitant medication requirements
throughout Studies M16-067. (ICTRP)
not available
Primary and secondary end points
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score;Percentage of Participants with Adverse Events (AE) (ICTRP)
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement;Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement;Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission;Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days;Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0;Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency;Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain;Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission;Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0;Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score;Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ);Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements;Sub-Study 1: Percentage of Participants Achieving No Tenesmus;Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week;Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms;Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
ABBVIE INC., AbbVie (ICTRP)
Secondary trial IDs
2023-506994-36-00, M16-066 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03398135 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available