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

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ClinicalTrials.gov Identifier: NCT03105128
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 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 of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : November 14, 2020
Estimated Study Completion Date : November 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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.
Drug: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
Other Name: ABBV-066 BI 655066

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

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.
Drug: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
Other Name: ABBV-066 BI 655066

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.
Drug: risankizumab IV
Risankizumab administered by intravenous infusion
Other Name: ABBV-066 BI 655066

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

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




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 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. 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.

  2. 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.

  3. 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.

  4. Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12 [ Time Frame: 12 weeks ]
    Participants who underwent surgery related to CD.

  5. 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.

  6. 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.

  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 endoscopic healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.

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

  10. 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.

  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 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.

  13. 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.

  14. 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.



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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 conventional or 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 (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
  • Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or 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): NCT03105128


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

  Show 369 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03105128     History of Changes
Other Study ID Numbers: M16-006
2016-003123-32 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases