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Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536404
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Study Start Date : November 2015
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod (APD334) High Dose Drug: Etrasimod
Other Name: APD334

Active Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Long-term safety and tolerability as measured by treatment-emergent adverse events (AEs) and treatment-emergent serious adverse events (SAEs) up to 30 days following discontinuation of the study drug. [ Time Frame: 40 weeks post completion of the APD334-003 study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed the APD334-003 study

Exclusion Criteria:

  • Patients who did not complete the APD334-003 study

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): NCT02536404


Locations
Show Show 115 study locations
Sponsors and Collaborators
Arena Pharmaceuticals
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02536404    
Other Study ID Numbers: APD334-005
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases