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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: 1% OPA-15406 ointment; Drug: 0.3% OPA-15406 ointment

• Registration Number: NCT03961529
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-26
• Study Start: 2019-05-14
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Primary Completion: 2020-11-11
• Study Completion: 2020-11-11
• Status Verified: 2021-10
• Results First Submitted: 2021-10-21
• Results First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Results First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% OPA-15406 ointment	1% OPA-15406 ointment	Twice daily
0.3% OPA-15406 ointment	0.3% OPA-15406 ointment	Twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Responder Rate of Investigator's Global Assessment (IGA)	Week 52	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.
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)	Week 52	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.

Trial Locations

Locations (1)

Shirao clinic of pediatrics and pediatric allergy; 🇯🇵 Hiroshima, Japan