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

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ClinicalTrials.gov Identifier: NCT03345849
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 26, 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 as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Upadacitinib Drug: Placebo for Upadacitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 501 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 Conventional and/or Biologic Therapies
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Arm A
Participants will receive upadacitinib dose A for 12 weeks.
Drug: Upadacitinib
It will be administered once daily.
Other Name: ABT-494

Experimental: Arm B
Participants will receive placebo for 12 weeks.
Drug: Placebo for Upadacitinib
This will be orally administered.




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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  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 who discontinue corticosteroid use and achieve clinical remission [ Time Frame: Week 12 ]
    This is assessed in participants taking corticosteroids at Baseline.

  4. 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.

  5. 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.

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

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

  8. 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.

  9. Proportion of participants with hospitalizations due to CD [ Time Frame: Week 12 ]
    This is assessed by reviewing participant's hospitalization data.

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


Other Outcome Measures:
  1. Change from Baseline in Short Form 36 (SF-36) [ Time Frame: Week 0 to Week 12 ]
    The SF-36 questionnaire is a self-administered multi-domain scale with 36 items.



Information from the National Library of Medicine

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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 one or more conventional and/or biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in the opinion of the investigator.

Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).

  • If female, participant 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.

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): NCT03345849


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: NCT03345849     History of Changes
Other Study ID Numbers: M14-433
2017-001240-35 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 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
Efficacy
Safety
Crohn's Disease

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents