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A Study of the Efficacy and Safety of Risankizumab in Participants With 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: NCT03105102
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The study consists of 4 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 intravenous 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, another AbbVie risankizumab Crohn's disease study, 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;
  • Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.

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 Drug: Risankizumab On-Body Injector (OBI) 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)
Actual Enrollment : 1337 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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : June 9, 2026
Estimated Study Completion Date : June 9, 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 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 will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
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 will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
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

Drug: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
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 other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Drug: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4)
Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Drug: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI

Drug: Risankizumab On-Body Injector (OBI)
Subcutaneous (SC) injection; on-body injector (OBI)
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI




Primary Outcome Measures :
  1. Sub-Study 1 and Sub-Study 2: 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. The CDAI clinical remission is defined as a CDAI score of < 150.

  2. Sub-Study 1 and Sub-Study 2: 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 and Sub-Study 2: 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 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0 [ Time Frame: Week 52 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease

  3. Sub-Study 1 and Sub-Study 2: Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 52 ]
    Endoscopic healing was assessed using SES-CD.

  4. Sub-Study 1 and Sub-Study 2: 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 and Sub-Study 2: 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.

  6. Sub-Study 1 and Sub-Study 2: 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.

  7. Sub-Study 1 and Sub-Study 2: 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.

  8. Sub-Study 1 and Sub-Study 2: Percentage of Participants With Stool Frequency (SF) Remission [ Time Frame: Week 52 ]
    SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.

  9. Sub-Study 1 and Sub-Study 2: Percentage of Participants With Abdominal Pain (AP) Remission [ Time Frame: Week 52 ]
    AP Remission is defined by an average daily AP <= 1 and not worse than baseline.

  10. Sub-Study 1 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response [ Time Frame: Week 52 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

  11. Sub-Study 1 and Sub-Study 2: 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.

  12. Sub-Study 1 and Sub-Study 2: 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).

  13. Sub-Study 1 and Sub-Study 2: 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.

  14. Sub-Study 1 and Sub-Study 2: Percentage of Participants With CD-Related Hospitalizations [ Time Frame: Up to Week 52 ]
    Participants with an event that results in admission to the hospital.

  15. Sub-Study 1 and Sub-Study 2: 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.

  16. Sub-Study 1 and Sub-Study 2: 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 other AbbVie risankizumab Crohn's disease study.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
  • Sub-Study 4:

    • Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
    • Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).

Exclusion Criteria:

  • Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR 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 another AbbVie risankizumab Crohn's disease study 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 another AbbVie risankizumab Crohn's disease study.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

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


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: April 13, 2021
Last Verified: April 2021
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)
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
SKYRIZI
Crohn's Disease (CD)
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