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Trial record 1 of 2 for:    M15-991
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A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105102
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : May 26, 2020
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 participants 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 participants 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 participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 : May 17, 2027

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 SC Subcutaneous (SC) Injection

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 SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

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 SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

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 IV Intravenous (IV) infusion

Drug: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

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 SC Subcutaneous (SC) Injection

Drug: Risankizumab IV
Risankizumab IV Intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

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 SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI




Primary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants With Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission per average daily stool frequency (SF) and average daily AP score.

  2. Sub-Study 1: Percentage of Participants With Endoscopic Response [ 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).

  3. Sub-Study 3: Number of Participants With Adverse Events [ Time Frame: Up to Week 220 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.


Secondary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 52 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  2. Sub-Study 1: Percentage of Participants With Clinical Remission Among Participants With Clinical Remission in Week 0 [ Time Frame: Week 52 ]
    Clinical remission per average daily SF and average daily AP score.

  3. Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 52 ]
    Endoscopic healing was assessed using SES-CD.

  4. Sub-Study 1: Percentage of Participants With Endoscopic Remission [ 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. Sub-Study 1: Mean Change From Baseline of Induction in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [ Time Frame: Week 52 ]
    Response in IBDQ Bowel Symptom domain is defined as increase of IBDQ bowel symptom domain score >=8 from Baseline

  6. Sub-Study 1: Mean Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: 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.

  7. Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.

  8. Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Week 52 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  9. Sub-Study 1: Percentage of Participants With Clinical Remission and Endoscopic Response [ 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).

  10. Sub-Study 1: Percentage of Participants With Enhanced Clinical Response [ 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.

  11. Sub-Study 1: Percentage of Participants With Deep Remission [ 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).

  12. Sub-Study 1: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) in Participants With Any EIMs at Baseline of Induction [ 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.

  13. Sub-Study 1: Percentage of Participants With CD-Related Hospitalizations [ Time Frame: Up to Week 52 ]
    Participants with an event that results in admission to the hospital.

  14. Sub-Study 1: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline of Induction [ Time Frame: Week 52 ]
    Participants without draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study.

  15. Sub-Study 1: Percentage of Participants With Crohn's Disease (CD)-Related Surgeries [ Time Frame: Up to Week 52 ]
    Participants who underwent surgery related to CD.



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

Inclusion Criteria:

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

Exclusion Criteria:

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), or had an adverse event (AE) during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant 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
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03105102    
Other Study ID Numbers: M16-000
2016-003191-50 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
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:
risankizumab
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