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

NCT05667623 | Completed Phase 3

• 1 other identifier: 271-403-00014
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

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 the percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades. Subjects with missing Investigator's Global Assessment data will be handled as non-responders.

  4 weeks

Secondary Outcomes (17)

• Change from baseline in Investigator's Global Assessment 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

• Eczema Area and Severity Index 50 (improvement of ≥50% 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

Other Outcomes (5)

• Adverse events

  4 weeks/24 weeks

• Plasma concentrations of OPA-15406

  Week 4

• Clinical laboratory tests

  4 weeks/24 weeks

Study Arms (2)

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/24 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 vehicle of OPA-15406 vehicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks/24 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.

Other: 0% OPA-15406 Vehicle

Interventions

1% OPA-15406 Ointment DRUG

Twice-daily administration for 4 weeks/24 weeks.

Also known as: 0% OPA-15406 Vehicle

1% OPA-15406 Ointment

0% OPA-15406 Vehicle OTHER

Twice-daily administration for 4 weeks/24 weeks.

0% OPA-15406 Vehicle

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization status: Outpatient.
• Age: 15 to 70 years old, inclusive (at time of obtaining informed consent), either male or female (only for 4 weeks double blind treatment).
• Able to provide written informed consent. For subjects under 18 years old (Korea: 19 years old), written informed consent must be obtained from both the subject and the subject's legal guardian.
• Diagnosis of AD based on the criteria of Hanifin and Rajka. (See Appendix 1).
• History of AD for at least 3 years.
• Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit (only for 4 weeks double blind treatment).
• IGA score of 2 or 3 at the screening and baseline visit (only for 4 weeks double blind treatment).

You may not qualify if:

• Subjects who are pregnant, possibly pregnant, or breastfeeding, who desire to become pregnant or to have their partner become pregnant during the trial period and up until 30 days after the final administration of IMP, or who are unable to either remain abstinent or employ at least two of the specified birth control methods (vasectomy, tubal ligation, vaginal diaphragm, intrauterine device \[IUD\], birth control pill, condom with spermicide, etc.) during the trial period and up until 30 days after the final administration of IMP.
• Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
• Subjects who have a concurrent or history of skin disease other than AD (e.g., acne, psoriasis, etc.) and who are judged inappropriate for assessment of AD in the present trial.
• Subjects who have an active viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox) or clinical signs of such infection.
• Subjects with a current or history of malignancy within the previous 5 years.
• Subjects with a current or history of recurrent bacterial infection resulting in hospitalization or requiring intravenous antibiotic treatment within the past 2 years.
• Subjects with a clinically significant complication or history of any of the following disorders that the investigator judges would prevent safe conduct of the trial or impact efficacy assessment of the IMP:
• Cardiac disease (e.g., rheumatic fever or heart valve replacement).
• Endocrinologic disease (e.g., severe or uncontrolled diabetes).
• Pulmonary disease.
• Neurologic disease.
• Psychiatric disease.
• Hepatic disease (e.g., carriers of hepatitis B, hepatitis C, etc.).
• Renal disease.
• Hematologic disease.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, 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

• Jianzhong Zhang, PHD

  Peking University People'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 2, 2022
• First Posted: December 28, 2022
• Study Start: February 6, 2023
• Primary Completion: June 17, 2024
• Study Completion: November 29, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)