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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

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: NCT03398135
Recruitment Status : Active, not recruiting
First Posted : January 12, 2018
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: risankizumab Drug: placebo for risankizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1242 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 Ulcerative Colitis
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : September 25, 2028
Estimated Study Completion Date : September 25, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Substudy 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
 Drug: placebo for risankizumab
subcutaneous (SC) injection
Experimental: Substudy 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: Substudy 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: Substudy 3: OL Extension Risankizumab
Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: OL Continuous Treatment Extension - Dose 1
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
 Drug: risankizumab
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Experimental: OL Continuous Treatment Extension - Dose 2
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
 Drug: risankizumab
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 Achieving Clinical Remission per Adapted Mayo Score [ Time Frame: Week 52 ]
    Clinical remission per Adapted Mayo Score.

  2. Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to Week 300 ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.


Secondary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

  2. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement [ Time Frame: Week 52 ]
    Percentage of participants achieving histologic-endoscopic mucosal improvement.

  3. Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission per endoscopy subscore.

  4. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days [ Time Frame: Week 52 ]
    Clinical remission per Adapted Mayo Score.

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 [ Time Frame: Week 52 ]
    Clinical remission per Adapted Mayo Score.

  6. Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency [ Time Frame: Week 52 ]
    Percentage of participants achieving no bowel urgency.

  7. Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain [ Time Frame: Week 52 ]
    Percentage of participants achieving no abdominal pain.

  8. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission [ Time Frame: Week 52 ]
    Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.

  9. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

  10. Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 52 ]
    Clinical response per Adapted Mayo Score.

  11. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Week 0 to 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.

  12. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  13. Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements [ Time Frame: Week 52 ]
    Percentage of participants achieving no nocturnal bowel movements.

  14. Sub-Study 1: Percentage of Participants Achieving No Tenesmus [ Time Frame: Week 52 ]
    Percentage of participants achieving no tenesmus.

  15. Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week [ Time Frame: Baseline (Week 0) to Week 52 ]
    Change in number of fecal incontinence episodes per week.

  16. Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms [ Time Frame: Baseline (Week 0) to Week 52 ]
    Change in number of days per week with sleep interrupted due to UC symptoms.

  17. Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization [ Time Frame: Through Week 52 ]
    Participants with an exposure adjusted occurrence of UC 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.


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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:

- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria:

  • Participants who have 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 M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
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): NCT03398135


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:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03398135    
Other Study ID Numbers: M16-066
2016-004676-22 ( EudraCT Number )
2023-506994-36-00 ( Other Identifier: EU CT )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 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:
ABBV-066
BI 655066
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs