NCT05287126

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis


Sponsor: Pfizer

Purpose of this study?

 

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.



Key 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


Key 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



Primary Outcome Measures:

 

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52



Secondary Outcome Measures:

   

•Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [Time Frame: 4 hours (± 15 minutes) post-dose]

•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]

•Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [Time Frame: Week 12]

•Proportion of Participants Achieving Endoscopic Improvement at Week 12 [Time Frame: Week 12]

•Proportion of Participants Achieving Endoscopic Improvement at Week 52 [Time Frame: Week 52]

•Proportion of Participants Achieving Symptomatic Remission at Week 12 [Time Frame: Week 12]

•Proportion of Participants Achieving Symptomatic Remission at Week 52 [Time Frame: Week 52]

•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]

•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]

•Proportion of Participants Achieving Clinical Response at Week 12 [Time Frame: Week 12]

Proportion of Participants Achieving Clinical Response at Week 52 [Time Frame: Week 52]

•Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [Time Frame: Week 12]

•Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [Time Frame: Week 52]

•Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [Time Frame: Week 12]

•Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [Time Frame: Week 52]

•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.


Study Locations in Europe: Austria, Belgium, Japan, Poland, Slovakia, Spain

 

Estimated Study Completion Date: 2031-08-07

 

Further information on clinicaltrial.gov - trial number NCT05287126




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