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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 : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: Upadacitinib (ABT-494) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Upadacitinib
Administered orally, once daily (QD)
Drug: Upadacitinib (ABT-494)
Upadacitinib will be orally administered

Experimental: Placebo
Administered orally, once daily (QD)
Drug: Placebo
Placebo will be orally administered




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore.

  2. Percentage of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission defined by endoscopic subscore.

  3. Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo score.

  4. Percentage of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]
    Clinical response per Partial Adapted Mayo score.

  5. Percentage of participants who reported no bowel urgency [ Time Frame: At Week 8 ]
    Bowel urgency is monitored electronically via a handheld device.

  6. Percentage of participants who reported no abdominal pain [ Time Frame: At Week 8 ]
    Abdominal pain information will be collected electronically via a handheld device.

  7. Percentage of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    Defined by Geboes score.

  8. 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.

  9. Percentage of participants with mucosal healing [ Time Frame: At Week 8 ]
    Defined by the endoscopic and histologic variables.

  10. Percentage of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Percentage of participants with UC-related hospitalizations

  11. Percentage of participants with UC-related surgeries [ Time Frame: Through Week 8 ]
    Participants who underwent surgery related to UC will be assessed.

  12. Percentage of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]
    Defined by increase of IBDQ fatigue item score



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03653026


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03653026     History of Changes
Other Study ID Numbers: M14-675
2016-000642-62 ( EudraCT Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 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

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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:
Upadacitinib
ABT-494
Ulcerative Colitis
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
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents