NCT05667623

To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD

A Multinational, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.

Detailed description

1. Screening period After obtaining informed consent, the investigator will perform a screening examination. The screening period is defined as the period between the day of obtaining informed consent and the day of baseline visit (0 - 30 days). 2. Assessment period (4 weeks double blind treatment period) The assessment period is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). The subject who meets the inclusion criteria and does not meet the exclusion criteria at the baseline visit will be allocated to the 1% formulation of OPA-15406 or the comparator (vehicle \[placebo\]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, the examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of Week 4 visit, a withdrawal visit will be performed for that subject. 3. 4 Weeks Double Blind The trial period for individual subject is the period from the day of obtaining the subject's written informed consent to the day of the Week 4 visit or withdrawal visit. For subjects who missed the Week 4 visit or withdrawal visit, the day of discontinuation will be the day when the investigator determined that the subject was to be withdrawn from the trial. It does not include the follow-up period for AE.To evaluate the efficacy (secondary endpoint) and safety of IMP (1% OPA-15406 ointment) when administered twice-daily for 4 weeks in adult patients with AD. 4. 24 Weeks Open label, long term treatment period (China only) To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 1% OPA-15406 open treatment for up to 24 weeks based on the informed consent of the subjects.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	1% OPA-15406 Ointment	Twice-daily administration for 4 weeks/24 weeks.
OTHER	0% OPA-15406 Vehicle	Twice-daily administration for 4 weeks/24 weeks.

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-06-17
• Completion: 2024-11-29
• First posted: 2022-12-28
• Last updated: 2025-08-29

Locations

1 site across 1 country: China