Ulcerative Colitis (UC)
Conditions
Keywords
ABBV-066, BI 655066
Brief summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Interventions
DRUGrisankizumab
subcutaneous (SC) injection
subcutaneous (SC) injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score | Week 52 | Clinical remission per Adapted Mayo Score. |
| Percentage of Participants with Adverse Events (AE) | Up to Week 300 | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Week 52 | Endoscopic improvement per endoscopy subscore. |
| Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement | Week 52 | Percentage of participants achieving histologic-endoscopic mucosal improvement. |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Week 52 | Endoscopic remission per endoscopy subscore. |
| Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days | Week 52 | Clinical remission per Adapted Mayo Score. |
| Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 | Week 52 | Clinical remission per Adapted Mayo Score. |
| Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency | Week 52 | Percentage of participants achieving no bowel urgency. |
| Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain | Week 52 | Percentage of participants achieving no abdominal pain. |
| Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission | Week 52 | Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore. |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 | Week 52 | Endoscopic improvement per endoscopy subscore. |
| Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score | Week 52 | Clinical response per Adapted Mayo Score. |
| Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Week 0 to Week 52 | The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week. |
| Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline (Week 0) to Week 52 | The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease. |
| Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements | Week 52 | Percentage of participants achieving no nocturnal bowel movements. |
| Sub-Study 1: Percentage of Participants Achieving No Tenesmus | Week 52 | Percentage of participants achieving no tenesmus. |
| Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week | Baseline (Week 0) to Week 52 | 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 | Baseline (Week 0) to Week 52 | 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 | Through Week 52 | Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital. |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed