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A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

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ClinicalTrials.gov Identifier: NCT03104413
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 579 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
Estimated Primary Completion Date : June 22, 2020
Estimated Study Completion Date : June 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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 Name: ABBV-066 BI 655066

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 Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 2 (Induction Period 1)
Subjects randomized to receive risankizumab dose 2 in Induction Period 1
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Name: ABBV-066 BI 655066

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 Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 1 (Induction Period 1)
Subjects randomized to receive risankizumab dose 1 in Induction Period 1.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Name: ABBV-066 BI 655066

Placebo Comparator: Placebo (Induction Period 1)
Subjects randomized to receive placebo for risankizumab in Induction Period 1.
Drug: placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.




Primary Outcome Measures :
  1. Percentage of participants with endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).

  2. Percentage of participants with clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per average daily SF and average daily AP score.


Secondary Outcome Measures :
  1. Percentage of participants with enhanced clinical response and endoscopic response at Week 12 [ Time Frame: 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. Endoscopic response defined as decrease from Baseline in SES-CD.

  2. Percentage of participants with clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 4 [ Time Frame: Week 4 ]
    Clinical remission per average daily SF and average daily AP score.

  3. Percentage of participants with resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, 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.

  4. Percentage of participants with endoscopic healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.

  5. Percentage of participants with hospitalization through Week 12 [ Time Frame: Week 12 ]
    Participants with an event that results in admission to the hospital.

  6. Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  7. Percentage of participants with endoscopic remission at Week 12 [ Time Frame: Week 12 ]
    Endoscopic remission is defined as decrease in SES-CD as compared to baseline

  8. Percentage of participants with enhanced clinical response at Week 4 [ Time Frame: Week 4 ]
    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.

  9. Percentage of participants with enhanced clinical response at Week 12 [ Time Frame: 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 draining fistulas at Week 12 in participants with draining fistulas at Baseline [ Time Frame: Week 12 ]
    Participants with draining fistulas at Week 12 in subjects who had draining fistulas at baseline.

  11. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The CSS is a patient questionnaire to assess severity of Crohn's symptoms.

  12. Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: Week 12 ]
    Response in IBDQ Bowel Symptom domain is defined as increase of IBDQ bowel symptom domain score >= 8 from Baseline

  13. Percentage of participants achieving response in IBDQ fatigue item [ Time Frame: Week 12 ]
    Response in IBDQ fatigue item is defined as increase of IBDQ fatigue item score >=1 from Baseline



Information from the National Library of Medicine

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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, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
  • Diagnosis of CD for at least 3 months prior to 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, subject must meet the contraception recommendations

Exclusion Criteria:

  • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
  • Subjects 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 (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03104413     History of Changes
Other Study ID Numbers: M15-991
2016-003190-17 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
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)
Analytic Code
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