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

NCT03961529 | Completed Phase 3 Results

• 1 other identifier: 271-102-00006
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Rate of Investigator's Global Assessment (IGA)

  Week 52

• Responder Rate of Eczema Area and Severity Index 75 (EASI 75)

  Week 52

Study Arms (2)

0.3% OPA-15406 ointment

EXPERIMENTAL

Twice daily

Drug: 0.3% OPA-15406 ointment

1% OPA-15406 ointment

EXPERIMENTAL

Twice daily

Drug: 1% OPA-15406 ointment

Interventions

0.3% OPA-15406 ointment DRUG

Twice daily

0.3% OPA-15406 ointment

1% OPA-15406 ointment DRUG

Twice daily

1% OPA-15406 ointment

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shirao clinic of pediatrics and pediatric allergy

Hiroshima, Japan

Location

Related Publications (1)

• 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.

  PMID: 35716332 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Osamu Sato

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 23, 2019
• Study Start: May 14, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: November 19, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

JP (1)