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Trial record 1 of 2 for:    NCT03105102
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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 : March 3, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
  • 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.
  • OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

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 : AbbVie has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1336 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

Arms and Interventions
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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
Experimental: CTE: Open Label Continuous Treatment Extension
Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
 Drug: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI


Outcome Measures
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Primary 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. The CDAI clinical remission is defined as a CDAI score of < 150.

  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.

  4. Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration [ Time Frame: Up to Week 16 ]
    Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.

  5. Sub-Study 4: Percentage of Participants who had no Potential Hazards [ Time Frame: Up to Week 16 ]
    Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.

  6. Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16 [ Time Frame: Up to Week 16 ]

    SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.

    Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.


  7. Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16 [ Time Frame: Up to Week 16 ]
    Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.


Secondary 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 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: 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: 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: 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: 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: 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: 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: 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 > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

  11. Sub-Study 1: Percentage of Participants With Deep Remission [ Time Frame: Week 52 ]
    Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).

  12. Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52 [ Time Frame: Up to Week 52 ]
    Participants with an event that results in admission to the hospital.


Other Outcome Measures:
  1. 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 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 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52 [ Time Frame: Up to Week 52 ]
    Participants with an event that results in admission to the hospital.


Eligibility Criteria
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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.


Layout table for eligibility information
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:

  • 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.
Contacts and Locations
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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
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 3, 2023
Last Verified: March 2023
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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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:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs