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A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

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ClinicalTrials.gov Identifier: NCT02819635
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE September 26, 2016
Estimated Primary Completion Date April 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Substudy 1/Substudy 2: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1 and not greater than Baseline, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.
  • Substudy 3: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 52 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1 and not greater than Baseline, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Substudy 1/Substudy 2: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.
  • Substudy 3: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 44 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.
Change History Complete list of historical versions of study NCT02819635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Substudy 3: Proportion of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score, defined as Stool Frequency Subscore (SFS) <= 1, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore <= 1.
  • Substudy 1/Substudy 2: Proportion of participants achieving clinical response per Adapted Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in rectal bleeding subscore (RBS) >= 1 or an absolute RBS of 0 or 1.
  • Substudy 3: Proportion of participants achieving clinical remission per Full Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1
  • Substudy 1/Substudy 2: Proportion of participants achieving clinical remission per Full Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical remission is defined as a Full Mayo score <= 2 with no subscore > 1
  • Substudy 3: Proportion of participants with endoscopic improvement at Week 44 [ Time Frame: At Week 44 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1
  • Substudy 1/Substudy 2: Proportion of participants with endoscopic improvement at Week 8 [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Substudy 1/Substudy 2: Proportion of participants with endoscopic improvement at Week 8 [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1
  • Substudy 1/Substudy 2: Proportion of participants achieving clinical remission per Full Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical remission is defined as a Full Mayo score <= 2 with no subscore > 1
  • Substudy 1/Substudy 2: Proportion of participants achieving clinical response per Adapted Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in rectal bleeding subscore (RBS) >= 1 or an absolute RBS <= 1.
  • Substudy 3: Proportion of participants with endoscopic improvement at Week 44 [ Time Frame: At Week 44 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1
  • Substudy 3: Proportion of participants achieving clinical remission per Full Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1
  • Substudy 3: Proportion of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score, defined as Stool Frequency Subscore (SFS) <= 1, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore <= 1.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission in order to identify the induction dose of upadacitinib for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis (UC)
Intervention  ICMJE
  • Drug: Placebo
    Tablet
  • Drug: Updacitinib (ABT-494)
    Tablet
    Other Name: Upadacitinib
Study Arms  ICMJE
  • Experimental: Updacitinib (ABT-494) Dose B
    Administered orally, once daily.
    Intervention: Drug: Updacitinib (ABT-494)
  • Experimental: Updacitinib (ABT-494) Dose A
    Administered orally, once daily.
    Intervention: Drug: Updacitinib (ABT-494)
  • Experimental: Updacitinib (ABT-494) Dose C
    Administered orally, once daily.
    Intervention: Drug: Updacitinib (ABT-494)
  • Experimental: Updacitinib (ABT-494) Dose D
    Administered orally, once daily.
    Intervention: Drug: Updacitinib (ABT-494)
  • Placebo Comparator: Placebo
    Administered orally, once daily.
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
844
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
1055
Estimated Study Completion Date  ICMJE February 24, 2022
Estimated Primary Completion Date April 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
  • Demonstrated an inadequate response to, loss of response to, or intolerance to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
  • If female, participant must meet the criteria for Contraception Recommendations.
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
  • Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
  • Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any abnormal results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819635
Other Study ID Numbers  ICMJE M14-234
2016-000641-31 ( 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 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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2019

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