Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: 0.3% OPA-15406 ointment; Drug: 1% OPA-15406 ointment

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • Shirao Clinic of Pediatrics and Pediatric Allergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: At least 2 years (at time of obtaining informed consent)
• Diagnosis of AD based on the Japanese Dermatological Association's criteria
• Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations

Exclusion Criteria:

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.3% OPA-15406 ointment; Twice daily	Drug: 0.3% OPA-15406 ointment; Twice daily
Experimental: 1% OPA-15406 ointment; Twice daily	Drug: 1% OPA-15406 ointment; Twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)	The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).	Treatment period (52 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate of 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 52. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.	Week 52
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)	The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.	Week 52

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 271-102-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No