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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

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: NCT03398135
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : May 21, 2020
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 : 760 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 Who Responded to Induction Treatment in M16-067 or M16-065
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 4, 2022
Estimated Study Completion Date : November 7, 2023

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 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 2: Open-label 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 3: Open-label 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.


Secondary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants with Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission 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, Remained Corticosteroid Free for 90 days, and Achieved Clinical Remission per Adapted Mayo Score in Participants Taking Steroids at Baseline (of induction). [ Time Frame: Week 52 ]
    Clinical remission per Adapted Mayo Score.

  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 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 Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

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

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

  9. Sub-Study 1: Percentage of Participants with Hospitalization [ Time Frame: Through Week 52 ]
    Participants with an event that results in admission to the hospital.

  10. Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) [ Time Frame: Week 0 to Week 52 ]
    The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.

  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 with Mucosal Healing [ Time Frame: Week 52 ]
    Mucosal healing defined as endoscopic and histologic remission.

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

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

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

  16. 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.

  17. Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and Endoscopic Subscore of 0 [ Time Frame: At Week 52 ]
    The SFS, RBS, and endoscopic subscore describe disease severity.

  18. Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS) ≤ 1 [ Time Frame: Through Week 52 ]
    The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.

  19. Sub-Study 1: Percentage of Participants with Rectal Bleeding Subscore (RBS) = 0 [ Time Frame: Through Week 52 ]
    The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.

  20. Sub-study 1: Change from Baseline of Induction in Partial Adapted Mayo Score [ Time Frame: Through Week 52 ]
    The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.

  21. Sub-Study 1: Change in Full Mayo Score [ Time Frame: Week 0 to Week 52 ]
    The Full Mayo Score ranges determines disease severity. A negative change in Full Mayo Score indicates improvement.

  22. Sub-Study 1: Change in SFS [ Time Frame: Week 0 to Week 52 ]
    The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.

  23. Sub-Study 1: Change in RBS [ Time Frame: Week 0 to Week 52 ]
    The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.

  24. Sub-Study 1: Change in High Sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Week 0 to Week 52 ]
    High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from week 0 in CRP is assessed at each time point.

  25. Sub-Study 1: Change in Fecal Calprotectin (FCP) [ Time Frame: Week 0 to Week 52 ]
    Stool samples were analyzed by a central laboratory for fecal calprotectin (FCP)qualitative measurement. Results are reported for participants in each category.

  26. Sub-Study 1: Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) [ Time Frame: At Week 52 ]
    The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as an assessment of the endoscopy findings scoring system for additional exploratory analyses.

  27. Sub-Study 1: Change in European Quality of Life 5 Dimensions (EQ-5D-5L) [ Time Frame: Week 0 to Week 52 ]
    The European Quality of Life 5 Dimensions (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.

  28. Sub-Study 1: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC) [ Time Frame: Week 0 to Week 52 ]
    The WPAI UC questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis. The self-administered questionnaire measures the effect of the participant's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  29. Sub-study 1: Time to Loss of Clinical Response per Partial Adapted Mayo in Patients with Response per Partial Adapted Mayo [ Time Frame: At Week 0 ]
    The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.

  30. Sub-Study 1: Change in Patient Global Impression of Severity (PGIS) [ Time Frame: Week 0 to Week 52 ]
    The PGIS is a response scale that describes the severity of the participants disease.

  31. Sub-Study 1: Change in Patient Global Impression of Change (PGIC) scores [ Time Frame: Through Week 52 ]
    The PGIC is a response scale. The participant will be asked by the Investigator or qualified designee to rate their change in their disease status.

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

  33. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). [ Time Frame: Through Week 52 ]
    Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).

  34. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). [ Time Frame: Through Week 52 ]
    Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).

  35. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and SFS ≤ 1 (and not Worse than Baseline of Induction) and RBS = 1 and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). [ Time Frame: Through Week 52 ]
    Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).

  36. Sub-Study 3: Percentage of Participants with Clinical Response per Partial Adapted Mayo Score [ Time Frame: Through Week 300 ]
    The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.

  37. Sub-Study 3: Percentage of Participants with Clinical Remission per Adapted Mayo Score with Endoscopy [ Time Frame: Through Week 300 ]
    Clinical remission per Adapted Mayo Score.

  38. Sub-Study 3: Percentage of Participants with Clinical Response per Adapted Mayo Score with Endoscopy [ Time Frame: Through Week 300 ]
    Clinical response per Adapted Mayo score.

  39. Sub-Study 3: Time to Loss of Clinical Response per Partial Mayo Score [ Time Frame: Through Week 300 ]
    The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.

  40. Sub-Study 3: Time to Loss of Clinical Remission per Adapted Mayo Score with Endoscopy [ Time Frame: Through Week 300 ]
    Clinical remission per Adapted Mayo Score.

  41. Sub-Study 3: Time too Loss of Clinical Response per Adapted Mayo Score with Endoscopy [ Time Frame: Through Week 300 ]
    Clinical response per Adapted Mayo score.

  42. Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use with Clinical Response per Partial Adapted Mayo Score in Participants Taking Steroids at Baseline (of Induction). [ Time Frame: Through Week 300 ]
    The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS, in participants taking steroids at baseline (of induction).

  43. Sub-Study 3: Percentage of Participants with Endoscopic Improvement [ Time Frame: Through Week 300 ]
    Endoscopic improvement per endoscopy subscore.

  44. Sub-Study 3: Percentage of Participants with Endoscopic Remission [ Time Frame: Through Week 300 ]
    Endoscopic remission per endoscopy subscore.

  45. Sub-Study 3: Percentage of Participants with Mucosal Healing [ Time Frame: Through Week 300 ]
    Mucosal healing defined as endoscopic and histologic remission.

  46. Sub-Study 3: Percentage of Participants with Histologic Remission [ Time Frame: Through Week 300 ]
    Histologic remission per Geboes Score.

  47. Sub-Study 3: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) [ Time Frame: Week 0 to Week 300 ]
    The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.

  48. Sub-Study 3: Percentage of Participants with Hospitalization [ Time Frame: Through Week 300 ]
    Participants with an event that results in admission to the hospital.

  49. Sub-Study 3: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries [ Time Frame: Through Week 300 ]
    Participants who underwent surgery related to UC.

  50. Sub-Study 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Week 0 to Week 300 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

  51. Sub-Study 3: Change in 36-Item Short Form Health Status Survey (SF-36) [ Time Frame: Week 0 to Week 300 ]
    The SF-36 is an indicator of overall health status.

  52. Sub-Study 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Through Week 300 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  53. Sub-Study 3: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC) [ Time Frame: Through Week 300 ]
    The WPAI UC questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis. The self-administered questionnaire measures the effect of the participant's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  54. Sub-Study 3: Change in European Quality of Life 5 Dimensions (EQ-5D-5L) [ Time Frame: Through Week 300 ]
    The European Quality of Life 5 Dimensions (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.

  55. Sub-Study 3: Change in RBS [ Time Frame: Through Week 300 ]
    The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.

  56. Sub-Study 3: Change in SFS [ Time Frame: Through Week 300 ]
    The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.

  57. Sub-Study 3: Change in Fecal Calprotectin (FCP) [ Time Frame: Through Week 300 ]
    Stool samples were analyzed by a central laboratory for fecal calprotectin (FCP)qualitative measurement. Results are reported for participants in each category.

  58. Sub-Study 3: Change in High Sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Through Week 300 ]
    High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from week 0 in CRP is assessed at each time point.

  59. Sub-Study 3: Change in Patient Global Impression of Severity (PGIS) [ Time Frame: Week 0 to Week 300 ]
    The PGIS is a response scale that describes the severity of the participants disease.

  60. Sub-Study 3: Change in Patient Global Impression of Change (PGIC) scores [ Time Frame: Through Week 300 ]
    The PGIC is a response scale. The participant will be asked by the Investigator or qualified designee to rate their change in their disease status.

  61. Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of Induction). [ Time Frame: Through Week 300 ]
    Participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction).



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 M16-065 or 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 M16-065 or 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 M16-065 and 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


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 380 study locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
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: May 21, 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:
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