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An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

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: NCT03950232
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blinded treatment (either etrasimod 2 mg per day or placebo) during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either Study APD334-301 or APD334-302).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 702 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first
Other Name: APD334


Outcome Measures
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Primary Outcome Measures :
  1. Number and Severity of Safety Measures [ Time Frame: Up to approximately 5 years ]
    Safety as assessed by the evaluation of adverse events


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  2. Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores [ Time Frame: Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  3. Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  4. Proportion of Participants Achieving Non-invasive Response Assessed by Mayo Component Sub-scores [ Time Frame: Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  5. Proportion of Participants Remaining in Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  6. Proportion of Participants Achieving Symptomatic Response Assessed by Mayo Component Sub-scores [ Time Frame: Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  7. Longitudinal change from both Open-Label Extension and Parent Study in Mayo Component Sub-scores [ Time Frame: Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260 ]
  8. Proportion of Participants With Remission and Response Using Total Mayo Clinic Score [ Time Frame: Week 12, Week 52, up to Week 260 ]
  9. Percentage of Participants With Histologic Improvement at Each Visit With Endoscopy Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Up to approximately Week 260 ]
  10. Percentage of Participants With Histologic Remission at Each Visit With Endoscopy Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Up to Week 260 ]
  11. Time to Loss of Response Assessed by Mayo Component Sub-scores [ Time Frame: Up to Week 260 ]
  12. Proportion of Participants With Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline [ Time Frame: Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria:

    1. Participants previously enrolled in Study APD334-301 must have completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline or completed the Week 52 visit
    2. Participants previously enrolled in APD334 302 must have completed the Week 12 visit

Exclusion Criteria:

  • If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  • Experienced an adverse event that led to discontinuation from one of the parent studies
Contacts and Locations
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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): NCT03950232


Contacts
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Contact: Arena CT.gov Administrator 855-218-9153 ct.gov@arenapharm.com

Locations
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Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Chris Cabell, MD Arena Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03950232    
Other Study ID Numbers: APD334-303
2018-003987-29 ( EudraCT Number )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
Ulcerative Colitis
Etrasimod
APD334
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