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A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants 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 : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 844 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 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
Actual Study Start Date : September 26, 2016
Estimated Primary Completion Date : October 7, 2021
Estimated Study Completion Date : March 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Administered once daily.
 Drug: Placebo
Tablet; Oral
Experimental: Updacitinib (ABT-494) Dose A
Administered once daily.
 Drug: Updacitinib (ABT-494)
Tablet; Oral
Other Names:
  • Upadacitinib
  • RINVOQ
Experimental: Updacitinib (ABT-494) Dose B
Administered once daily.
 Drug: Updacitinib (ABT-494)
Tablet; Oral
Other Names:
  • Upadacitinib
  • RINVOQ
Experimental: Updacitinib (ABT-494) Dose C
Administered once daily.
 Drug: Updacitinib (ABT-494)
Tablet; Oral
Other Names:
  • Upadacitinib
  • RINVOQ
Experimental: Updacitinib (ABT-494) Dose D
Administered once daily.
 Drug: Updacitinib (ABT-494)
Tablet; Oral
Other Names:
  • Upadacitinib
  • RINVOQ


Outcome Measures
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Primary Outcome Measures :
  1. Substudy 1/Substudy 2: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [ Time Frame: At Week 8 ]
    Clinical remission per Adapted Mayo score.

  2. Substudy 3: Percentage Of Participants Who Achieve Clinical Remission Per Adapted Mayo Score [ Time Frame: At Week 52 ]
    Clinical remission per Adapted Mayo score.


Secondary Outcome Measures :
  1. Substudy 1: Percentage Of Participants With Endoscopic Improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore.

  2. Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score [ Time Frame: At Week 8 ]
    Clinical remission per Full Mayo score.

  3. Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo.

  4. Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score [ Time Frame: At Week 2 ]
    Percentage of participants achieving clinical response per Partial Mayo score.

  5. Substudy 1: Change in Full Mayo Score [ Time Frame: Baseline (Week 0) to Week 8 ]
    Change from baseline in Full Mayo score.

  6. Substudy 1: Percentage Of Participants With Endoscopic Remission [ Time Frame: At Week 8 ]
    Remission defined by endoscopic subscore.

  7. Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement [ Time Frame: At Week 8 ]
    Histologic improvement defined by Geboes score.

  8. Substudy 2: Percentage Of Participants With Endoscopic Improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore.

  9. Substudy 2: Percentage Of Participants With Endoscopic Remission [ Time Frame: At Week 8 ]
    Remission defined by endoscopic subscore.

  10. Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo.

  11. Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score [ Time Frame: At Week 2 ]
    Percentage of participants achieving clinical response per Partial Mayo score.

  12. Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement [ Time Frame: At Week 8 ]
    Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.

  13. Substudy 2: Percentage Of Participants Who Report No Bowel Urgency [ Time Frame: At Week 8 ]
    Percentage of participants who report no bowel urgency.

  14. Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain [ Time Frame: At Week 8 ]
    Percentage of participants who reported no abdominal pain.

  15. Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement [ Time Frame: At Week 8 ]
    Histologic improvement defined by Geboes score.

  16. Substudy 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [ Time Frame: Baseline (Week 0) to Week 8 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  17. Substudy 2: Percentage Of Participants With Mucosal Healing [ Time Frame: At Week 8 ]
    Percentage of participants with mucosal healing.

  18. Substudy 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score [ Time Frame: Baseline (Week 0) to Week 8 ]
    The FACIT system is a collection of quality of life (QOL) questionnaires targeted to the management of cancer and other chronic illnesses.

  19. Substudy 3: Percentage Of Participants With Endoscopic Improvement [ Time Frame: At Week 52 ]
    Endoscopic improvement defined by endoscopic subscore.

  20. Substudy 3: Percentage Of Participants Who Maintain Clinical Remission Per Adapted Mayo Score Among Participants Who Received Clinical Remission Per Adapted Mayo Score in Study M14-234 (Substudy 1 or 2) Or M14-675 [ Time Frame: At Week 52 ]
    Percentage of participants who maintain clinical remission per Adapted Mayo score among participants who received clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or M14-675.

  21. Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo score And Were Corticosteroid Free ≥ 90 days [ Time Frame: At Week 52 ]
    Percentage of participants who achieved clinical remission per Adapted Mayo score and were corticosteroid free ≥ 90 days among participants in clinical remission in the end of the induction treatment in Study M14-234 (Substudy 1 or 2) or M14-675.

  22. Substudy 3: Percentage Of Participants With Endoscopic Improvement Among Participants Who Had Endoscopic Improvement In Study M14-234 (Substudy 1 or 2) Or Study M14-675 [ Time Frame: At Week 52 ]
    Percentage of participants with endoscopic improvement among participants who had endoscopic improvement in Study M14-234 (Substudy 1 or 2) or Study M14-675.

  23. Substudy 3: Percentage Of Participants With Endoscopic Remission [ Time Frame: At Week 52 ]
    Percentage of participants with endoscopic remission.

  24. Substudy 3: Percentage Of Participants Who Maintain Clinical Response Per Adapted Mayo Score [ Time Frame: At Week 52 ]
    Percentage of participants who maintain clinical response per Adapted Mayo score.

  25. Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement [ Time Frame: At Week 52 ]
    Histologic-endoscopic mucosal improvement defined by Endoscopic subscore and Geboes score.

  26. Substudy 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [ Time Frame: Baseline (Week 0) to Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  27. Substudy 3: Percentage Of Participants With Mucosal Healing [ Time Frame: At Week 52 ]
    Percentage of participants with mucosal healing.

  28. Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency [ Time Frame: At Week 52 ]
    Percentage of participants who reported no bowel urgency.

  29. Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain [ Time Frame: At Week 52 ]
    Percentage of participants who reported no abdominal pain.

  30. Substudy 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline (Week 0) to Week 52 ]
    The FACIT-F is a validated tool that measures an individual's level of fatigue during their usual daily activities.

  31. Substudy 3: Incidence Rate Of Ulcerative Colitis (UC)-Related Hospitalization [ Time Frame: At Week 52 ]
    Incidence of UC-related hospitalization.

  32. Substudy 3: Incidence Rate of Ulcerative Colitis (UC)-Related Surgeries [ Time Frame: At Week 52 ]
    Incidence rate of UC-related surgeries.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

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 authority. If approval has not been granted, only participants >= 18 years old will be enrolled.

Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

  • 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 at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.

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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.

  • 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 Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any abnormal results.
Contacts and Locations
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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): NCT02819635


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

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02819635    
Other Study ID Numbers: M14-234
2016-000641-31 ( EudraCT Number )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
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)
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)
Moderately to Severely Active UC
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