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A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

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ClinicalTrials.gov Identifier: NCT03105102
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The study consists of 3 sub-studies, as follows:

  • Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991
  • Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to induction treatment in Study M16-006 or Study M15-991;
  • Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in subjects who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 959 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : October 18, 2025
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1)
Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Drug: placebo for risankizumab SC
placebo for risankizumab administered by subcutaneous (SC) injection

Experimental: Open-label Risankizumab (Sub-Study 3)
Participants who completed Sub-study 1 or Sub-study 2 or Study M15-989 will receive open-label risankizumab beginning at Week 56.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1)
Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2)
Participants randomized to receive 1 dose of double-blind risankizumab dose 1 followed by open-label risankizumab for 52 weeks.
Drug: placebo for risankizumab IV
placebo for risankizumab administered by intravenous (IV) infusion

Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1)
Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2)
Participants randomized to receive 1 dose of double-blind risankizumab dose 2 followed by open-label risankizumab for 52 weeks.
Drug: placebo for risankizumab SC
placebo for risankizumab administered by subcutaneous (SC) injection

Drug: risankizumab IV
risankizumab administered by intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Percentage of participants with endoscopic response at Week 52 [ Time Frame: Week 52 ]
    Endoscopic response defined as decrease from Baseline of the induction study 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 52 [ Time Frame: Week 52 ]
    Clinical remission per average daily SF and average daily AP score.


Secondary Outcome Measures :
  1. Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52 [ Time Frame: Week 52 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  2. Percentage of participants with deep remission at Week 52 [ Time Frame: Week 52 ]
    Deep remission defined as subjects with both clinical remission (per average daily SF and average daily AP score) and endoscopic healing (assessed using SES-CD).

  3. Percentage of participants with hospitalizations through Week 52 [ Time Frame: 52 weeks ]
    Participants with an event that results in admission to the hospital.

  4. Percentage of subjects with endoscopic remission at Week 52 [ Time Frame: Week 52 ]
    Endoscopic Remission is defined as SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer

  5. Percentage of participants with endoscopic healing at Week 52 [ Time Frame: Week 52 ]
    Endoscopic healing was assessed using SES-CD.

  6. Percentage of participants with Crohn's disease (CD)-related surgeries through Week 52 [ Time Frame: 52 weeks ]
    Participants who underwent surgery related to CD.

  7. Percentage of participants with enhanced clinical response at Week 52 [ Time Frame: Week 52 ]
    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.

  8. Percentage of participants with sustained clinical remission [ Time Frame: Week 0, Week 52 ]
    Sustained clinical remission defined as clinical remission per average daily SF and average daily AP score at both Week 0 and Week 52.

  9. Percentage of participants who discontinued corticosteroid use at Week 52 [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use at Week 52.

  10. Percentage of participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study [ Time Frame: Week 52 ]
    Participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study.

  11. 36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The SF-36 is an indicator of overall health status.

  12. Percentage of participants who discontinued corticosteroid use for 90 days and achieved clinical remission per average daily SF and average daily AP score at Week 52 [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.

  13. Crohn's Symptoms Severity (CSS): Change from week 0 to week 52 [ Time Frame: Week 0, Week 52 ]
    The CSS is a patient questionnaire to assess severity of Crohn's symptoms.

  14. Percentage of participants with clinical remission per average daily SF and average daily AP score and endoscopic response at Week 52 [ Time Frame: Week 52 ]
    Clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

  15. Percentage of participants with resolution of extra-intestinal manifestations (EIMs) at week 52 in subjects with EIMs at baseline of the induction study [ Time Frame: Week 52 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

  16. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.



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:

  • Subjects who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
  • Subjects have completed the study M16-006 or M15-991 and have achieved clinical response.

Exclusion Criteria:

  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
  • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

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): NCT03105102


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

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

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03105102     History of Changes
Other Study ID Numbers: M16-000
2016-003191-50 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
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

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:
risankizumab
ABBV-066
BI 655066

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