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Clinical trial

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 I

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Last updated:17th Mar 2015
Identifier: NCT02365649

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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 219 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 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
Study Start Date: March 17, 2015
Primary Completion Date: November 25, 2016
Study Completion Date: August 4, 2017

Arm:
- Active Comparator:
Induction Period ABT-494 Low Dose
- Active Comparator: Induction Period ABT-494 Low/Medium Dose
- Active Comparator: Induction Period ABT-494 Low/Medium Dose
- Active Comparator: Induction Period ABT-494 High Dose
- Active Comparator: Induction Period ABT-494 High Dose
- Active Comparator: Induction Period ABT-494 High Dose
- Active Comparator: Extension Phase ABT-494 Low Dose
- Active Comparator: Extension Phase ABT-494 Low Dose
- Active Comparator: Extension Phase ABT-494 Low Dose

Category Value
Date last updated at source 2017-11-06
Study type(s) Interventional
Expected enrolment 219
Study start date 2015-03-17
Estimated primary completion date 2016-11-25

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