Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524611
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 24, 2020
Last Update Posted Date August 3, 2021
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • 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 Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Percentage of Participants Achieving Clinical Remission (Non-Inferiority of Risankizumab vs Ustekinumab) [ Time Frame: Week 24 ]
    Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
  • Percentage of Participants Achieving Clinical Remission (Superiority of Risankizumab vs Ustekinumab) [ Time Frame: Week 48 ]
    Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • 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 Remission [ Time Frame: Week 48 ]
    Endoscopic remission is defined as decrease in SES-CD<=4 and at lease a 2-point reduction versus Baseline and no sub-score greater than 1 in any individual variable.
  • Percentage of Participants Achieving Clinical Remission (Patient Reported Outcome [PRO]-2) [ Time Frame: Week 48 ]
    Clinical remission [PRO-2] is defined as average daily stool frequency (SF) <= 2.8 and not worse than Baseline AND average daily abdominal pain (AP) score <= 1 and not worse than 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 Remission [ Time Frame: Week 48 ]
    Steroid-free remission is defined as discontinuation of corticosteroid use for 90 days and achieving clinical remission at Week 48 in participants taking steroids at Baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Percentage of Participants Achieving Endoscopic Response (Superiority of Risankizumab vs Ustekinumab) [ Time Frame: Up to 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 Remission (Superiority of Risankizumab vs Ustekinumab) [ Time Frame: Week 48 ]
    Endoscopic remission is defined as decrease in SES-CD<=4 and at lease a 2-point reduction versus Baseline and no sub-score greater than 1 in any individual variable.
  • Percentage of Participants Achieving Clinical Remission (Patient Reported Outcome [PRO]-2) (Superiority of Risankizumab vs Ustekinumab) [ Time Frame: Week 48 ]
    Clinical remission [PRO-2] is defined as average daily stool frequency (SF) <= 2.8 and not worse than Baseline AND average daily abdominal pain (AP) score <= 1 and not worse than Baseline.
  • Percentage of Participants Achieving Steroid-Free Remission (Superiority of Risankizumab vs Ustekinumab) [ Time Frame: Week 48 ]
    Steroid-free remission is defined as discontinuation of corticosteroid use for 90 days and achieving clinical remission at Week 48 in participants taking steroids at Baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.

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.

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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease (CD)
Intervention  ICMJE
  • Drug: Risankizumab
    Intravenous (IV) Infusion
    Other Names:
    • ABBV-066
    • SKYRIZI
  • Drug: Risankizumab
    Subcutaneous (SC) Injection
    Other Names:
    • ABBV-066
    • SKYRIZI
  • Drug: Ustekinumab
    Intravenous (IV) infusion
  • Drug: Ustekinumab
    Subcutaneous (SC) injection
Study Arms  ICMJE
  • Experimental: Risankizumab Dose A Followed by Dose B
    Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous risankizumab dose B every 8 weeks through Week 48.
    Interventions:
    • Drug: Risankizumab
    • Drug: Risankizumab
  • Experimental: Risankizumab Dose A Followed by Dose C
    Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous risankizumab dose C every 8 weeks through Week 48.
    Interventions:
    • Drug: Risankizumab
    • Drug: Risankizumab
  • Active Comparator: Ustekinumab
    Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
    Interventions:
    • Drug: Ustekinumab
    • Drug: Ustekinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
508
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 28, 2023
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czechia,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04524611
Other Study ID Numbers  ICMJE M20-259
2020-002674-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP