A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

NCT07184645 | Not Yet Recruiting Phase 3

• 1 other identifier: 271-102-00044
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• Success rate in Investigator's Global Assessment (IGA)

  The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.

  Week 4

Study Arms (2)

OPA-15406 foam

EXPERIMENTAL

Drug: OPA-15406

Vehicle

EXPERIMENTAL

Drug: Vehicle

Interventions

OPA-15406 DRUG

0.3% foam or 1% foam, topical, twice daily, for 8 weeks

Also known as: difamilast

OPA-15406 foam

Vehicle DRUG

vehicle, topical, twice daily, for 8 weeks

Vehicle

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
• Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
• Participants with an IGA score of 2 or 3 at the screening and baseline examinations

You may not qualify if:

• Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
• Participants who have been treated with OPA-15406 ointment in the past

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sumire Dermatology Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

difamilast

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)