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

NCT05650320 | Completed Phase 3

• 1 other identifier: 271-403-00013
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• Success rate in Investigator's Global Assessment at Week 4

  Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades from baseline. Subjects with missing Investigator's Global Assessmen data will be handled as non-responders.

  4 weeks

Secondary Outcomes (18)

• Change from baseline in Investigator's Global Assessment at Week 4

  4 weeks

• Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.

  4 weeks

• Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4.

  4 weeks

• Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4

  4 weeks

• Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4

  4 weeks

Study Arms (3)

0.3% OPA-15406 Ointment

EXPERIMENTAL

The 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Drug: 0.3% OPA-15406 Ointment

1% OPA-15406 Ointment

EXPERIMENTAL

The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Drug: 1% OPA-15406 Ointment

0% OPA-15406 Vehicle

PLACEBO COMPARATOR

The 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Other: 0% OPA-15406 vehicle

Interventions

0.3% OPA-15406 Ointment DRUG

Twice-daily administration for 4 weeks.

0.3% OPA-15406 Ointment

1% OPA-15406 Ointment DRUG

Twice-daily administration for 4 weeks.

1% OPA-15406 Ointment

0% OPA-15406 vehicle OTHER

Twice-daily administration for 4 weeks.

0% OPA-15406 Vehicle

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
• Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
• Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).

You may not qualify if:

• \. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

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

• Lin Ma

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: February 17, 2023
• Primary Completion: July 21, 2024
• Study Completion: January 15, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)