At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 366 enrolled
Drug / intervention
0.3% OPA-15406 ointment +1 moredrug
Likely dose
OPA-15406 ointment: 0.3% or 1%, applied twice dailyAI-extracted
Key inclusion· 3
- ✓Age at least 2 years at informed consent
- ✓Diagnosis of atopic dermatitis based on Japanese Dermatological Association criteria
- ✓Atopic dermatitis affecting ≥5% of body surface area (excluding scalp)
Key exclusion· 1
- ✕AD or contact dermatitis flare-up (rapid intensification) within 28 days prior to baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
In the news
1 article- Neumora drug fails two more Phase 3 trials, biotech to lay off 35% of staffEndpoints News·2026-06-15
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A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
In Brief
A Phase 3 clinical trial evaluating 0.3% OPA-15406 ointment and 1% OPA-15406 ointment for Atopic Dermatitis. Completed, enrolled 366 participants across 1 site.
Detailed Summary
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartMay 2019
First PostedMay 2019
Primary CompletionNov 2020
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartMay 14, 2019
Primary CompletionNov 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago
Interventions
0.3% OPA-15406 ointmentdrug
Twice daily
1% OPA-15406 ointmentdrug
Twice daily