Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

NCT03908970 | Completed Phase 3 Results

• 1 other identifier: 271-102-00007
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity

  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 4. 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.

  At Week 4

Secondary Outcomes (2)

• Change From Baseline in Eczema Area and Severity Index (EASI) Score

  Baseline, Week 4

• Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score

  Baseline, Week 4

Study Arms (2)

1% OPA-15406

EXPERIMENTAL

Twice daily

Drug: 1% OPA-15406

Placebo

PLACEBO COMPARATOR

Twice daily

Drug: Placebos

Interventions

1% OPA-15406 DRUG

Twice daily

1% OPA-15406

Placebos DRUG

Twice daily

Placebo

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:

• Diagnosis of AD based on the Japanese Dermatological Association's criteria
• History of AD for at least 3 years
• Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
• IGA score of 2 or 3 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)

Kitago Hifuka Clinic

Sapporo, Japan

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

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 9, 2019
• Study Start: March 25, 2019
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Locations

JP (1)