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A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

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: NCT03105128
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE May 10, 2017
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Percentage of participants with clinical remission per 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.
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • Percentage of Participants With Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
  • 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.
  • Change From Baseline of Induction in 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants With Abdominal Pain (AP) Remission [ Time Frame: Week 12 ]
    AP remission is defined using the average daily AP, and not worse than baseline.
  • Percentage of Participants With Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission is defined as decrease in SES-CD as compared to baseline
  • 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.
  • Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.
  • 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.
  • Percentage of Participants With CD-Related Hospitalization [ Time Frame: Up to Week 12 ]
    Participants with an event that results in admission to the hospital.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • 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.
  • 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.
  • 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.
  • Percentage of participants with clinical remission per average daily SF and average daily AP score at Week 4 [ Time Frame: Week 4 ]
    Clinical remission per average daily SF and average daily AP score.
  • 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.
  • Percentage of participants with endoscopic healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.
  • 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.
  • Percentage of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects 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.
  • Percentage of participants with hospitalization through Week 12 [ Time Frame: 12 weeks ]
    Participants with an event that results in admission to the hospital.
  • Percentage of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline [ Time Frame: Baseline, Week 12 ]
    Participants with draining fistulas at Week 12 in participants who had draining fistulas at baseline.
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The SF-36 is an indicator of overall health status.
  • Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12 [ Time Frame: 12 weeks ]
    Participants who underwent surgery related to CD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Brief Summary The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: placebo for risankizumab
    Placebo for risankizumab administered by intravenous infusion
  • Drug: risankizumab IV
    Risankizumab administered by intravenous infusion
    Other Names:
    • ABBV-066 BI 655066
    • SKYRIZI
  • Drug: risankizumab SC
    Risankizumab administered by subcutaneous (SC) injection
    Other Names:
    • ABBV-066 BI 655066
    • SKYRIZI
Study Arms  ICMJE
  • Experimental: Risankizumab Dose 1 (Period 1)
    Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Experimental: Risankizumab Dose 2 (Period 1)
    Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Placebo Comparator: Placebo (Period 1)
    Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
    Intervention: Drug: placebo for risankizumab
  • Experimental: Risankizumab Dose 1 (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.
    Intervention: Drug: risankizumab IV
  • Experimental: Risankizumab Dose 2 (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.
    Intervention: Drug: risankizumab SC
  • Experimental: Risankizumab Dose 3 (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.
    Intervention: Drug: risankizumab SC
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
940
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 8, 2021
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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 conventional or 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   Estonia,   Germany,   Greece,   Hong Kong,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Finland,   France,   Hungary,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT03105128
Other Study ID Numbers  ICMJE M16-006
2016-003123-32 ( 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.: No
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 January 2021

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