A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

NCT05372653 | Completed Phase 3 Results

• 1 other identifier: 271-102-00016
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)

  The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). The investigator or sub investigator 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 was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.

  Week 4

Secondary Outcomes (1)

• Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI)

  Week4

Study Arms (1)

OPA-15406

EXPERIMENTAL

Drug: OPA-15406

Interventions

OPA-15406 DRUG

0.3% or 1% ointment, topical, twice daily, for 52 weeks

Also known as: difamilast

OPA-15406

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
• Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
• Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations

You may not qualify if:

• Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sotobo Children's Clinic

Isumi, Japan

Location

Related Publications (2)

• Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Oct 31. doi: 10.1007/s13555-025-01581-1. Online ahead of print.

  PMID: 41171590 DERIVED

• Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. An Interim Report of a Phase 3, Long-Term, Open-Label Study to Evaluate Efficacy and Safety of Difamilast Ointment in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2443-2455. doi: 10.1007/s13555-024-01236-7. Epub 2024 Jul 29.

  PMID: 39075274 DERIVED

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

+81363617366

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: May 23, 2022
• Primary Completion: December 29, 2022
• Study Completion: November 29, 2023
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2024-02

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)