Crohn's Disease (CD)
Conditions
Keywords
Crohn's Disease (CD), Risankizumab, Ustekinumab, SKYRIZI
Brief summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGRisankizumab
Intravenous (IV) Infusion
DRUGUstekinumab
Intravenous (IV) infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline. * Crohn's disease activity index (CDAI) score 220 - 450 at Baseline. * Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD). * Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
Exclusion criteria
* Current diagnosis of ulcerative colitis or indeterminate colitis. * Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol). * Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab). * Currently know complications of CD (strictures, short bowel, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 24 | Week 24 | Clinical remission is defined as Crohn's disease activity index (CDAI)\<150. |
| Percentage of Participants Achieving Endoscopic Remission | Week 48 | Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer. |
| Number of Participants Reporting Adverse Events | Up to 220 Weeks | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 48 | Week 48 | Clinical remission is defined as Crohn's disease activity index (CDAI)\<150. |
| Percentage of Participants Achieving Endoscopic Response at Week 48 | Week 48 | Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
| Percentage of Participants Achieving Endoscopic Response at Week 24 | Week 24 | Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
| Percentage of Participants Achieving Steroid-Free Endoscopic Remission | Week 48 | Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48. |
| Percentage of Participants Achieving Steroid-Free Clinical Remission | Week 48 | Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed