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Trial record 1 of 1 for:    NCT03104413
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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

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: NCT03104413
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: placebo for risankizumab IV Drug: risankizumab SC Drug: risankizumab IV Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : May 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Risankizumab Dose 1 (Induction Period 1)
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
 Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • ABBV-066 BI 655066
  • SKYRIZI
Experimental: Risankizumab Dose 2 (Induction Period 1)
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
 Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • ABBV-066 BI 655066
  • SKYRIZI
Placebo Comparator: Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab in Induction Period 1.
 Drug: placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
Experimental: Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
 Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Names:
  • ABBV-066 BI 655066
  • SKYRIZI
Experimental: Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
 Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066 BI 655066
  • SKYRIZI
Experimental: Risankizumab Dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
 Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066 BI 655066
  • SKYRIZI


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  2. Percentage of Participants With Endoscopic Response [ Time Frame: Week 12 ]
    Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).


Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Remission [ Time Frame: Up to Week 12 ]
    Clinical remission per average daily SF and average daily AP score.

  2. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Up to Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  3. Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.

  4. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 4 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  5. Percentage of Participants With CDAI Clinical Response and Endoscopic Response [ Time Frame: Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease. Endoscopic response defined as decrease from Baseline in SES-CD.

  6. Percentage of Participants With Stool Frequency (SF) Remission [ Time Frame: Week 12 ]
    SF remission is defined using the average daily SF, and not worse than baseline.

  7. Percentage of Participants With Abdominal Pain (AP) Remission [ Time Frame: Week 12 ]
    AP remission is defined using the average daily AP score, and not worse than baseline.

  8. Percentage of Participants With Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission is defined as decrease in SES-CD as compared to baseline

  9. Percentage of Participants With Enhanced Clinical Response [ Time Frame: Up to Week 12 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

  10. Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.

  11. Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline [ Time Frame: Week 12 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

  12. Percentage of Participants With CD-Related Hospitalization [ Time Frame: Up to Week 12 ]
    Participants with an event that results in admission to the hospital.

  13. Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [ Time Frame: Week 12 ]
    Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.


Eligibility Criteria
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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:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of 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 CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to biologic therapy for CD.
  • If female, participant must meet the contraception recommendations.

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participants with unstable doses of concomitant Crohn's disease therapy.
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab).
  • Complications of Crohn's disease.
  • Having an ostomy or ileoanal pouch.
  • Known active Coronavirus Disease 2019 (COVID-19) infection.
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): NCT03104413


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Informed Consent Form  [PDF] October 30, 2019

More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03104413    
Other Study ID Numbers: M15-991
2016-003190-17 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 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.: No
Keywords provided by AbbVie:
ABBV-066
BI 655066
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs