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)

Phase 3

Active, not recruiting

• Conditions: Crohn's Disease (CD)
• Interventions: Drug: Ustekinumab; Drug: Risankizumab

• Registration Number: NCT04524611
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-24
• Study Start: 2020-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2028-02-15
• Study Completion: 2028-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 527

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ustekinumab	Ustekinumab	Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Risankizumab Dose A Followed by Dose B	Risankizumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Clinical Remission at Week 48	Week 48	Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
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.
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.

Trial Locations

Locations (300)

Advanced Gastroenterology, P.C /ID# 224396; 🇺🇸 Chandler, Arizona, United States

Southern California Res. Ctr. /ID# 223484; 🇺🇸 Coronado, California, United States

Hoag Memorial Hosp Presbyterian /ID# 224373; 🇺🇸 Irvine, California, United States

United Medical Doctors /ID# 223486; 🇺🇸 Los Alamitos, California, United States

TLC Clinical Research Inc /ID# 223467; 🇺🇸 Los Angeles, California, United States

Duplicate_UC Davis Medical Center /ID# 225700; 🇺🇸 Sacramento, California, United States

Duplicate_University of California, San Francisco /ID# 223621; 🇺🇸 San Francisco, California, United States

Duplicate_Western Connecticut Medical Group /ID# 223478; 🇺🇸 Danbury, Connecticut, United States

Duplicate_Medical Research Center of CT /ID# 223540; 🇺🇸 Hamden, Connecticut, United States

Yale Univ Digestive Diseases /ID# 224463; 🇺🇸 New Haven, Connecticut, United States

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