Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
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|ClinicalTrials.gov Identifier: NCT04524611|
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : May 12, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease (CD)||Drug: Risankizumab Drug: Ustekinumab||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||508 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy|
|Actual Study Start Date :||September 30, 2020|
|Estimated Primary Completion Date :||September 28, 2023|
|Estimated Study Completion Date :||January 12, 2028|
Experimental: Risankizumab Dose A Followed by Dose B
Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
Active Comparator: Ustekinumab
Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Intravenous (IV) infusion
Subcutaneous (SC) injection
- Percentage of Participants Achieving Clinical Remission at Week 24 [ Time Frame: Week 24 ]Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
- Percentage of Participants Achieving Endoscopic Remission [ Time Frame: 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 [ Time Frame: 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.
- Percentage of Participants Achieving Clinical Remission at Week 48 [ Time Frame: Week 48 ]Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
- Percentage of Participants Achieving Endoscopic Response at Week 48 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 48 ]Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524611
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Study Director:||ABBVIE INC.||AbbVie|