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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

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ClinicalTrials.gov Identifier: NCT02365649
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE February 19, 2015
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE March 17, 2015
Actual Primary Completion Date November 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02365649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: ABT-494
    Oral Dosing
    Other Name: Upadacitinib
  • Drug: Placebo
    Oral Dosing
Study Arms  ICMJE
  • Active Comparator: Induction Period ABT-494 Low Dose
    Induction Period ABT-494 Low Dose orally dosed twice a day
    Intervention: Drug: ABT-494
  • Active Comparator: Induction Period ABT-494 Low/Medium Dose
    Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
    Intervention: Drug: ABT-494
  • 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
    Intervention: Drug: ABT-494
  • Active Comparator: Induction Period ABT-494 High Dose
    Induction Period ABT-494 High Dose orally dosed twice a day
    Intervention: Drug: ABT-494
  • 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
    Intervention: Drug: ABT-494
  • Placebo Comparator: Induction Period Placebo
    Induction Period Placebo orally dosed twice a day
    Intervention: Drug: Placebo
  • Active Comparator: Extension Phase ABT-494 Low Dose
    Extension Phase ABT-494 Low Dose orally dosed twice a day
    Intervention: Drug: ABT-494
  • Active Comparator: Extension Phase ABT-494 Medium Dose
    Extension Phase ABT-494 Medium Dose orally dosed twice a day
    Intervention: Drug: ABT-494
  • Active Comparator: Extension Phase ABT-494 High Dose
    Extension Phase ABT-494 High Dose orally dosed twice a day
    Intervention: Drug: ABT-494
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2017)
219
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2015)
210
Actual Study Completion Date  ICMJE August 4, 2017
Actual Primary Completion Date November 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   Puerto Rico,   Romania,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02365649
Other Study ID Numbers  ICMJE M13-740
2014-003240-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ana Lacerda, MD AbbVie
PRS Account AbbVie
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP