Clinical trial

A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis

Name

271-102-00016

Description

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

Trial arms

Trial start

2022-05-23

Estimated PCD

2022-12-29

Trial end

2023-11-29

Status

Completed

Phase

Early phase I

Treatment

OPA-15406

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

Arms:

OPA-15406

Other names:

difamilast

Size

Primary endpoint

Success rate in Investigator's Global Assessment (IGA)

Week 4

Eligibility criteria

Inclusion Criteria: * 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 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}

Updated at

2024-02-20

1 organization

1 product

1 indication

Organization

Otsuka Pharmaceutical

Product

OPA-15406

Indication

Atopic Dermatitis