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Trial record 2 of 3 for:    APD334-302

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

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ClinicalTrials.gov Identifier: NCT03950232
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date October 6, 2021
Actual Study Start Date  ICMJE September 20, 2019
Estimated Primary Completion Date August 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Number and Severity of Safety Measures [ Time Frame: Up to approximately 5 years ]
Safety as assessed by the evaluation of adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
Number and Severity of Safety Measures [ Time Frame: Up to approximately 5 years ]
Safety be assessed by monitoring adverse events, laboratory abnormalities, and vital sign abnormalities.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2021)
  • Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
  • Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry [ Time Frame: Week 52 and Week 104 ]
  • Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
  • Change From Baseline in the Total Mayo Score [ Time Frame: Baseline, Week 52, and Week 104 ]
  • Change From Baseline in Partial Mayo Score [ Time Frame: Baseline, Week 52, Week 104, Week 156, and Week 260 ]
  • Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Proportion of Participants With Remission and Response Using Total Mayo Clinic Score [ Time Frame: Week 12, Week 52, up to Week 260 ]
  • 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 ]
  • 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 ]
  • Time to Loss of Response Assessed by Mayo Component Sub-scores [ Time Frame: Up to Week 260 ]
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2021)
  • Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Week 52 and Week 104 ]
  • Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Week 52 and Week 104 ]
  • Time to Loss of Response Assessed by Mayo Component Sub-scores [ Time Frame: Up to Week 260 ]
  • Proportion of Participants Achieving 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
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-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Etrasimod 2 mg
Intervention: Drug: Etrasimod
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2021)
912
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
702
Estimated Study Completion Date  ICMJE August 2027
Estimated Primary Completion Date August 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:

    1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
    2. Participants previously enrolled in APD334-302 (NCT03996369) 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 parent study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bulgaria,   Canada,   Chile,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Georgia,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lebanon,   Lithuania,   Mexico,   Moldova, Republic of,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950232
Other Study ID Numbers  ICMJE APD334-303
2018-003987-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arena Pharmaceuticals
Study Sponsor  ICMJE Arena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
PRS Account Arena Pharmaceuticals
Verification Date September 2021

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