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

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ClinicalTrials.gov Identifier: NCT03398135
Recruitment Status : Enrolling by invitation
First Posted : January 12, 2018
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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: 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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: risankizumab Drug: placebo for risankizumab 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 : 942 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 : December 15, 2023
Estimated Study Completion Date : May 23, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score [ Time Frame: Week 52 ]
    Clinical remission per Adapted Mayo Score.

  2. Sub-Study 3: 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 with Endoscopic Improvement [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

  2. Sub-Study 1: Percentage of Participants with Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ]
    Clinical remission per full Mayo Score.

  3. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of induction). [ Time Frame: Week 52 ]
    Percentage of participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction).

  4. 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.

  5. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, Remained Corticosteroid Free for 90 days and Achieved Clinical Remission in Participants who were Taking Steroids at Baseline (of induction) [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use.

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

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

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

  9. Sub-Study 1: Percentage of Participants with 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 with Ulcerative Colitis (UC) Related Hospitalization [ Time Frame: Through Week 52 ]
    Participants with a UC event that results in admission to the hospital.

  11. Sub-Study 1: Percentage of Participants with Histologic Remission [ Time Frame: Week 52 ]
    Histologic remission per Geboes Score.

  12. Sub-Study 1: Percentage of Participants who Reported No Abdominal Pain [ Time Frame: Week 52 ]
    Percentage of participants who reported no abdominal pain.

  13. Sub-Study 1: Percentage of Participants who Reported No Bowel Urgency [ Time Frame: Week 52 ]
    Percentage of participants who reported no bowel urgency.

  14. Sub-Study 1: Percentage of Participants with Mucosal Healing [ Time Frame: Week 52 ]
    Mucosal healing defined as endoscopic and histologic remission.

  15. 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.

  16. Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries [ Time Frame: Through Week 52 ]
    Participants who underwent surgery related to UC.

  17. 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.

  18. Sub-Study 1: Percentage of Participants who Reported No Nocturnal Bowel Movements [ Time Frame: Week 52 ]
    Percentage of participants who reported no nocturnal bowel movements.

  19. Sub-Study 1: Percentage of Participants who Reported No Tenesmus [ Time Frame: Week 52 ]
    Percentage of participants who reported no tenesmus.

  20. 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.

  21. 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.

  22. Sub-Study 1: Change in 36-Item Short Form Health Status Survey (SF-36) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The SF-36 is an indicator of overall health status.



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 Study 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 Study M16-067.

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
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03398135    
Other Study ID Numbers: M16-066
2016-004676-22 ( EudraCT Number )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 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:
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