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Trial record 2 of 2 for:    M14-431

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03345836
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : May 21, 2020
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 Other: Matching placebo for upadacitinib Drug: upadacitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 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 : June 6, 2021
Estimated Study Completion Date : June 6, 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
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ

Experimental: Arm B
Participants will receive placebo for 12 weeks.
Other: Matching placebo for upadacitinib
Oral; Tablet

Arm C
Participants will receive open-label upadacitinib dose A for 12 weeks.
Drug: upadacitinib
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ




Primary Outcome Measures :
  1. Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 12 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Percentage of Participants with Endoscopic Response [ Time Frame: Week 12 ]
    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.


Secondary Outcome Measures :
  1. Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) [ Time Frame: Week 4 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Percentage of Participants with Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission is defined per SES-CD.

  3. Percentage 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. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

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

  5. Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline (Week 0) to Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  6. Percentage of Participants Achieving Clinical Response 100 (CR-100) [ Time Frame: Week 2 ]
    Decrease of at least 100 points in CDAI from Baseline.

  7. Percentage of Participants Achieving Clinical Response 100 (CR-100) [ Time Frame: Week 12 ]
    Decrease of at least 100 points in CDAI from Baseline.

  8. Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 4 ]
    CDAI remission is defined as CDAI < 150.

  9. Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) [ Time Frame: Week 12 ]
    This is assessed during 12 week double-blind induction period by reviewing participant's hospitalization data.

  10. Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline [ Time Frame: Week 12 ]
    EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.



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:   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.

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
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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
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03345836    
Other Study ID Numbers: M14-431
2017-001226-18 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 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)
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
Crohn's Disease
Efficacy
Safety
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