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Trial record 1 of 1 for:    m13-740
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02365649
First received: February 16, 2015
Last updated: April 27, 2017
Last verified: April 2017
  Purpose
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

Condition Intervention Phase
Crohn's Disease Drug: ABT-494 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects who achieve endoscopic remission [ Time Frame: Up to Week 16 ]
    Endoscopic remission will be determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD).

  • Proportion of subjects who achieve clinical remission [ Time Frame: Week 16 ]
    Clinical remission to be determined at Week16


Secondary Outcome Measures:
  • Proportion of subjects who achieve Crohn's Disease Activity Index (CDAI) less than 150 [ Time Frame: Week 16 ]
    Outcome to be measured by using CDAI

  • Proportion of subjects with decrease in CDAI greater than or equal to 70 points [ Time Frame: Up to Week 16 ]
    Outcome to be measured by using CDAI

  • Proportion of subjects who achieve remission at Week 52 [ Time Frame: Week 52 ]
    Remission to be determined at Week 52


Estimated Enrollment: 210
Study Start Date: March 17, 2015
Estimated Study Completion Date: April 1, 2018
Primary Completion Date: November 25, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Induction Period ABT-494 Low Dose
Induction Period ABT-494 Low Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Induction Period ABT-494 Low/Medium Dose
Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Induction Period ABT-494 Twice Daily Medium/High Dose
Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Induction Period ABT-494 High Dose
Induction Period ABT-494 High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Induction Period ABT-494 Once Daily Medium/High Dose
Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Placebo Comparator: Induction Period Placebo
Induction Period Placebo orally dosed twice a day
Drug: Placebo
Oral Dosing
Active Comparator: Extension Phase ABT-494 Low Dose
Extension Phase ABT-494 Low Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Extension Phase ABT-494 Medium Dose
Extension Phase ABT-494 Medium Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib
Active Comparator: Extension Phase ABT-494 High Dose
Extension Phase ABT-494 High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

  Eligibility

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

Inclusion Criteria:

  1. Diagnosis of Crohn's disease (CD) for at least 90 days.
  2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
  3. Subject inadequately responded to or experience intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

  1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
  2. Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  3. Subjects with an ostomy or ileoanal pouch.
  4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  5. Subject who has short bowel syndrome.
  6. Subject with recurring infections or active Tuberculosis (TB).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02365649

  Show 115 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Ana Lacerda, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02365649     History of Changes
Other Study ID Numbers: M13-740
2014-003240-12 ( EudraCT Number )
Study First Received: February 16, 2015
Last Updated: April 27, 2017

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Adjuvants, Immunologic
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017