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

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ClinicalTrials.gov Identifier: NCT03398135
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects 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 subjects who completed Substudy 1 or 2.


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

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 : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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

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

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




Primary Outcome Measures :
  1. Percentage of participants with clinical remission per adapted Mayo Score at Week 52 [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.


Secondary Outcome Measures :
  1. Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0 [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.

  2. Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction) [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use.

  3. Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction). [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.

  4. Percentage of participants with endoscopic remission at Week 52 [ Time Frame: Week 52 ]
    Endoscopic remission per endoscopy subscore.

  5. Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.

  6. Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52 [ Time Frame: 52 weeks ]
    Participants who underwent surgery related to UC.

  7. Percentage of participants with hospitalization through Week 52 [ Time Frame: 52 weeks ]
    Participants with an event that results in admission to the hospital.

  8. 36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The SF-36 is an indicator of overall health status.

  9. Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  10. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [ Time Frame: Week 0, 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.

  11. Percentage of participants with endoscopic improvement at Week 52 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

  12. Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ]
    Clinical remission per full Mayo Score.

  13. Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.

  14. Percentage of participants with clinical response per adapted Mayo score at Week 52 [ Time Frame: Week 52 ]
    Clinical response per adapted Mayo score.

  15. Percentage of participants with histologic remission at Week 52 [ Time Frame: Week 52 ]
    Histologic remission per Geboes Score.

  16. Percentage of participants with mucosal healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing defined as endoscopic and histologic remission.



Information from the National Library of Medicine

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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:

  • Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response

Exclusion Criteria:

  • Subjects 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 subject unsuitable for this study
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Subject 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
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 363 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03398135     History of Changes
Other Study ID Numbers: M16-066
2016-004676-22 ( EudraCT Number )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
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

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:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases