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Trial record 1 of 1 for:    M20-259 | Crohn Disease
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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 : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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.


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 ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 : March 3, 2023
Estimated Study Completion Date : June 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Arm Intervention/treatment
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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI

Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI

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.
Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • ABBV-066
  • SKYRIZI

Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
  • ABBV-066
  • SKYRIZI

Active Comparator: Ustekinumab
Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Drug: Ustekinumab
Intravenous (IV) infusion

Drug: Ustekinumab
Subcutaneous (SC) injection




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04524611    
Other Study ID Numbers: M20-259
2020-002674-26 ( EudraCT Number )
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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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
Keywords provided by AbbVie:
Crohn's Disease (CD)
Risankizumab
Ustekinumab
SKYRIZI
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Gastroenteritis
Ustekinumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs