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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish)

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ClinicalTrials.gov Identifier: NCT03653026
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date February 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Percentage of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
It is defined by Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and endoscopic subscore.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
Proportion of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
It is defined as Stool Frequency Subscore (SFS) <=1 and not greater than baseline, Rectal Bleeding Subscore (RBS) of 0 and endoscopic subscore <=1.
Change History Complete list of historical versions of study NCT03653026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore.
  • Percentage of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission defined by endoscopic subscore.
  • Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo score.
  • Percentage of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]
    Clinical response per Partial Adapted Mayo score.
  • Percentage of participants who reported no bowel urgency [ Time Frame: At Week 8 ]
    Bowel urgency is monitored electronically via a handheld device.
  • Percentage of participants who reported no abdominal pain [ Time Frame: At Week 8 ]
    Abdominal pain information will be collected electronically via a handheld device.
  • Percentage of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    Defined by Geboes score.
  • Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]
    Defined by increase of IBDQ bowel symptom domain score.
  • Percentage of participants with mucosal healing [ Time Frame: At Week 8 ]
    Defined by the endoscopic and histologic variables.
  • Percentage of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Percentage of participants with UC-related hospitalizations
  • Percentage of participants with UC-related surgeries [ Time Frame: Through Week 8 ]
    Participants who underwent surgery related to UC will be assessed.
  • Percentage of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]
    Defined by increase of IBDQ fatigue item score
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Proportion of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <=1.
  • Proportion of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore =0.
  • Proportion of participants achieving clinical response per Adapted Mayo score [ 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 RBS >= 1 or an absolute RBS <= 1.
  • Proportion of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]
    It is defined as a decrease in the partial adapted mayo score >= 1 points and >= 30% from Baseline, PLUS a decrease in RBS>=1 or an absolute RBS<=1.
  • Proportion of participants who reported no bowel urgency [ Time Frame: At Week 8 ]
    Bowel urgency is monitored electronically via a handheld device.
  • Proportion of participants who reported no abdominal pain [ Time Frame: At Week 8 ]
    Abdominal pain information will be collected electronically via a handheld device.
  • Proportion of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    It is defined as decrease from Baseline in Geboes score
  • Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]
    It is defined as the increase of IBDQ bowel symptom domain score >=6
  • Proportion of participants with mucosal healing [ Time Frame: At Week 8 ]
    It is defined as the endoscopic and histologic remission
  • Proportion of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Participants with an UC related event that results in admission to the hospital will be assessed.
  • Proportion of participants with UC-related surgeries [ Time Frame: Through Week 8 ]
    Participants who underwent surgery related to UC will be assessed.
  • Proportion of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]
    It is defined as the increase of IBDQ fatigue item score >=1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Upadacitinib (ABT-494) 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 Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
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: Upadacitinib (ABT-494)
    Upadacitinib will be orally administered
  • Drug: Placebo
    Placebo will be orally administered
Study Arms  ICMJE
  • Experimental: Upadacitinib
    Administered orally, once daily (QD)
    Intervention: Drug: Upadacitinib (ABT-494)
  • Experimental: Placebo
    Administered orally, once daily (QD)
    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: August 28, 2018)
462
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 23, 2021
Estimated Primary Completion Date February 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants >= 16 and <=75 years of age at Baseline
  • Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh >=40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

  • Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
  • Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.

  • 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.
  • If female, participant must meet the contraception recommendation criteria.

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 who received azathioprine or 6-mercaptipurine (6-MP) within 10 days of Baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any prespecified abnormal hematologic results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, 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,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   Egypt,   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,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Belarus,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT03653026
Other Study ID Numbers  ICMJE M14-675
2016-000642-62 ( 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 November 2019

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