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A Study to Evaluate Etrasimod Treatment in Adolescents With 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. 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: NCT05287126
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod Drug: Etrasimod
Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.
Other Name: APD334




Primary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [ Time Frame: 4 hours (± 15 minutes) post-dose ]
  2. Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [ Time Frame: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
  3. Steady State Exposure Area Under Plasma Concentration-time Over Dosing Interval (AUCτ) of Etrasimod [ Time Frame: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
  4. Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [ Time Frame: Week 12 ]
  5. Proportion of Participants Achieving Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ]
  6. Proportion of Participants Achieving Endoscopic Improvement at Week 52 [ Time Frame: Week 52 ]
  7. Proportion of Participants Achieving Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
  8. Proportion of Participants Achieving Symptomatic Remission at Week 52 [ Time Frame: Week 52 ]
  9. Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 [ Time Frame: Week 12 ]
  10. Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 [ Time Frame: Week 52 ]
  11. Proportion of Participants Achieving Clinical Response at Week 12 [ Time Frame: Week 12 ]
  12. Proportion of Participants Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
  13. Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [ Time Frame: Week 12 ]
  14. Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ]
  15. Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [ Time Frame: Week 12 ]
  16. Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ]
  17. Number and Severity of Adverse Events [ Time Frame: Up to Week 52 ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
  • Participants are permitted to be receiving a therapeutic dose of select UC therapies

Exclusion criteria:

  • Severe extensive colitis
  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

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): NCT05287126


Contacts
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Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com

Locations
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United States, Tennessee
East Tennessee Children's Hospital, GI for Kids Recruiting
Knoxville, Tennessee, United States, 37922
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05287126    
Other Study ID Numbers: APD334-207
2021-003627-15 ( EudraCT Number )
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
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:
Pharmacokinetics
Adolescents
Active Ulcerative Colitis
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