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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

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ClinicalTrials.gov Identifier: NCT03345836
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

Condition or disease Intervention/treatment Phase
Crohn's Disease Other: Matching placebo for upadacitinib Drug: upadacitinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 855 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 of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : January 9, 2020
Estimated Study Completion Date : March 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm B
Participants will receive placebo for 12 weeks.
 Other: Matching placebo for upadacitinib
Tablet
Arm C
Participants will receive open-label upadacitinib dose A for 12 weeks.
 Drug: upadacitinib
Tablet
Other Name: ABT-494
Experimental: Arm A
Participants will receive upadacitinib dose A for 12 weeks.
 Drug: upadacitinib
Tablet
Other Name: ABT-494


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with clinical remission [ Time Frame: Week 12 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Proportion of participants with endoscopic response [ Time Frame: Week 12 ]
    Endoscopic response is defined as decrease in SES-CD from Baseline.


Secondary Outcome Measures :
  1. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: From Week 0 to Week 12 ]
    The FACIT-F questionnaire was developed to assess fatigue.

  2. Proportion of participants with enhanced clinical response [ Time Frame: Week 2 ]
    Enhanced Clinical Response defined as decrease in average daily SF and/or decrease in average daily AP score.

  3. Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 12 ]
    IBDQ bowel symptom domain response is defined as the increase of IBDQ bowel symptom domain score >= 8

  4. Proportion of participants with hospitalizations due to CD [ Time Frame: Week 12 ]
    This is assessed during 12 week double-blind induction period by reviewing participant's hospitalization data.

  5. Proportion of participants with clinical remission [ Time Frame: Week 4 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  6. Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) remission in participants with a Baseline CDAI of 220 to 450 [ Time Frame: Week 12 ]
    CDAI remission is defined as CDAI < 150.

  7. Proportion of participants with endoscopic remission [ Time Frame: Week 12 ]
    Endoscopic remission is defined per SES-CD.

  8. Proportion of participants with >= 50% reduction in draining fistulas [ Time Frame: Week 12 ]
    This is assessed in participants with draining fistulas at Baseline.

  9. Change from Baseline in Crohn's Symptoms Severity Questionnaire (CSS) [ Time Frame: From Week 0 to Week 12 ]
    The CSS is a self-administered questionnaire that consists of questions about how the participants felt in regards to their Crohn's disease.

  10. Proportion of participants who discontinue corticosteroid use for Crohn's disease (CD) and achieve clinical remission [ Time Frame: Week 12 ]
    This is assessed in participants taking corticosteroids at Baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
  • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
  • Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
  • Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Participant with ostomy or ileoanal pouch
  • Participant diagnosed with short gut or short bowel syndrome
  • Screening laboratory and other analyses show 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): NCT03345836


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

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Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03345836     History of Changes
Other Study ID Numbers: M14-431
2017-001226-18 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 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

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
Crohn's Disease
Efficacy
Safety

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases