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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) (SEQUENCE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524611
Recruitment Status : Active, not recruiting
First Posted : August 24, 2020
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.


Condition or disease Intervention/treatment Phase
Crohn's Disease (CD) Drug: Risankizumab Drug: Ustekinumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 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 : February 11, 2028
Estimated Study Completion Date : February 11, 2028

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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 (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.
 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


Outcome Measures
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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 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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).
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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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: August 25, 2022
Last Verified: August 2022
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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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