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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active 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: NCT03398148
Recruitment Status : Active, not recruiting
First Posted : January 12, 2018
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 12, 2018
Last Update Posted Date March 10, 2023
Actual Study Start Date  ICMJE March 7, 2018
Actual Primary Completion Date November 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2023)
Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score [ Time Frame: Week 12 ]
Clinical remission per adapted Mayo Score.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
Percentage of participants with clinical remission per adapted Mayo Score at Week 12 [ Time Frame: Week 12 ]
Clinical remission per adapted Mayo Score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2023)
  • Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.
  • Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline [ Time Frame: Week 12 ]
    Clinical remission per Full Mayo Score.
  • Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.
  • Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score [ Time Frame: Week 4 ]
    Clinical response per Partial Adapted Mayo Score (without endoscopy).
  • Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.
  • Sub-Study 1: Percentage of Participants with Hospitalization [ Time Frame: Through Week 12 ]
    Participants with an event that results in admission to the hospital.
  • Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) [ Time Frame: Week 12 ]
    Mucosal healing defined as endoscopic and histologic remission.
  • Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) [ Time Frame: Baseline Through Week 12 ]
    The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
  • Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline Through Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
  • Sub-Study 1: Change in Short Form-36 (SF-36) [ Time Frame: Baseline Through Week 12 ]
    The SF-36 is an indicator of overall health status.
  • Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Baseline Through Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries [ Time Frame: Through Week 12 ]
    Participants who underwent surgery related to UC.
  • Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.
  • Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.
  • Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) [ Time Frame: Week 12 ]
    Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score ≤ 3.1) at Week 12
  • Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.
  • Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4 [ Time Frame: Week 4 ]
    Clinical response per Partial Adapted Mayo Score (without endoscopy).
  • Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency [ Time Frame: Week 12 ]
    Percentage of participants who reported no bowel urgency.
  • Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain [ Time Frame: Week 12 ]
    Percentage of participants who reported no abdominal pain.
  • Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12 [ Time Frame: Week 12 ]
    Mucosal healing defined as endoscopic and histologic remission.
  • Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Baseline to Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score [ Time Frame: Baseline to Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
  • Sub-Study 2: Occurrence of UC-related Hospitalizations [ Time Frame: Baseline Through Week 12 ]
    Participants with an UC-related event that results in admission to the hospital.
  • Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements [ Time Frame: Week 12 ]
    Percentage of participants who reported no nocturnal bowel movements.
  • Sub-Study 2: Percentage of Participants Achieving No Tenesmus [ Time Frame: Week 12 ]
    Percentage of participants who reported no tenesmus.
  • Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week [ Time Frame: Baseline to Week 12 ]
    Change in number of fecal incontinence episodes per week.
  • Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms [ Time Frame: Baseline to Week 12 ]
    Change in number of days per week with sleep interrupted due to UC symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
  • Percentage of participants with endoscopic improvement at Week 12 [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.
  • Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline [ Time Frame: Week 12 ]
    Clinical remission per full Mayo Score.
  • Percentage of participants achieving clinical response per adapted Mayo Score at week 12 [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.
  • Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4 [ Time Frame: Week 4 ]
    Clinical response per partial adapted Mayo Score (without endoscopy).
  • Percentage of participants with endoscopic remission at Week 12 [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.
  • Percentage of participants with hospitalization through Week 12 [ Time Frame: 12 weeks ]
    Participants with an event that results in admission to the hospital.
  • Percentage of participants with mucosal healing at Week 12 [ Time Frame: Week 12 ]
    Mucosal healing defined as endoscopic and histologic remission.
  • Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
  • Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
  • 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The SF-36 is an indicator of overall health status.
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12 [ Time Frame: 12 weeks ]
    Participants who underwent surgery related to UC.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis (UC)
Intervention  ICMJE
  • Drug: risankizumab IV
    risankizumab intravenous (IV) infusion
    Other Names:
    • ABBV-066
    • BI 655066
  • Drug: placebo for risankizumab
    placebo for risankizumab
  • Drug: risankizumab SC
    risankizumab subcutaneous (SC) injection
    Other Names:
    • ABBV-066
    • BI 655066
Study Arms  ICMJE
  • Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1
    Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2
    Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3
    Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Placebo Comparator: Substudy 1, Induction 1: Double-blind Placebo
    Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
    Intervention: Drug: placebo for risankizumab
  • Experimental: Substudy 1, Induction 1: Open-label Risankizumab Dose 1
    Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)
    Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
    Intervention: Drug: risankizumab SC
  • Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
    Intervention: Drug: risankizumab SC
  • Experimental: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1
    Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Placebo Comparator: Substudy 2, Induction 1: Double-blind Placebo
    Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
    Interventions:
    • Drug: risankizumab IV
    • Drug: placebo for risankizumab
  • Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)
    Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
    Intervention: Drug: risankizumab IV
  • Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
    Intervention: Drug: risankizumab SC
  • Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3
    Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
    Intervention: Drug: risankizumab SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 29, 2022)
1554
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2018)
720
Estimated Study Completion Date  ICMJE May 25, 2023
Actual Primary Completion Date November 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   Denmark,   Egypt,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries American Samoa,   Australia,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT03398148
Other Study ID Numbers  ICMJE M16-067
2016-004677-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP