C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Conditions

Ulcerative Colitis

Brief summary

Clinical remission based on modified Mayo score (MMS) at Week 52

Detailed description

Clinical remission based on MMS at Week 12. Other secondary endpoints based on MMS score components, individually assessed at Week 12 and Week 52: •Clinical response •Endoscopic improvement •Corticosteroid-free remission endpoint Symptomatic remission at all time points up to Week 52 Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission PUCAI clinical response, Incidence and severity of adverse events, including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation Incidence and severity of laboratory abnormalities. Incidence of clinically significant vital sign abnormalities. Development and maturation assessment: change from baseline in z-scores height and weight, Tanner stage, Response to taste acceptability/palatability questionnaire on etrasimod tablets and granules, Etrasimod plasma concentrations

Related papers

No related papers found yet.

Interventions

DRUGPF-07915503

DRUGEtrasimod Arginine Blue

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission based on modified Mayo score (MMS) at Week 52	—

Secondary

Measure	Time frame
Clinical remission based on MMS at Week 12. Other secondary endpoints based on MMS score components, individually assessed at Week 12 and Week 52: •Clinical response •Endoscopic improvement •Corticosteroid-free remission endpoint Symptomatic remission at all time points up to Week 52 Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission PUCAI clinical response, Incidence and severity of adverse events, including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation Incidence and severity of laboratory abnormalities. Incidence of clinically significant vital sign abnormalities. Development and maturation assessment: change from baseline in z-scores height and weight, Tanner stage, Response to taste acceptability/palatability questionnaire on etrasimod tablets and granules, Etrasimod plasma concentrations	—

Measure

Time frame

Clinical remission based on MMS at Week 12. Other secondary endpoints based on MMS score components, individually assessed at Week 12 and Week 52: •Clinical response •Endoscopic improvement •Corticosteroid-free remission endpoint Symptomatic remission at all time points up to Week 52 Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission PUCAI clinical response, Incidence and severity of adverse events, including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation Incidence and severity of laboratory abnormalities. Incidence of clinically significant vital sign abnormalities. Development and maturation assessment: change from baseline in z-scores height and weight, Tanner stage, Response to taste acceptability/palatability questionnaire on etrasimod tablets and granules, Etrasimod plasma concentrations

—

Outcome results

None listed