drugset / Trial / NCT05650320

To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD

NCT05650320

Phase 3 Completed 240 enrolled Otsuka Beijing Research Institute
RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.

Timeline

Start
2023-02-17
Primary completion
2024-07-21
Completion
2025-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Difamilast Small molecule 0.3 %
Subject Difamilast Small molecule 1 %

Indications