Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

NCT03018691 | Completed Phase 2 Results

• 2 other identifiers: 271-102-00002JapicCTI-173484
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Experiencing AEs

  The number of subjects experiencing AEs will be calculated for each treatment group. Treatment-emergent adverse events (TEAEs) occurring after the start of IMP administration are summarized. The number of subjects with events, the number of events is obtained for all the TEAEs reported.

  Week 0-4

Secondary Outcomes (10)

• Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4

  Baseline and Week 4

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

  Baseline, Week 4

• Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score

  Baseline, Week 4

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

  Baseline, Hour 156

• Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score

  Baseline, Week 4

Study Arms (3)

0.3% OPA-15406 Ointments

EXPERIMENTAL

Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.

Drug: OPA-15406

1% OPA-15406 Ointments

EXPERIMENTAL

Subjects were treated with assigned 1% OPA-15406 ointment twice daily.

Drug: OPA-15406

Placebo Ointments

PLACEBO COMPARATOR

Subjects were treated with assigned 0% OPA-15406 ointment twice daily.

Drug: Placebos

Interventions

OPA-15406 DRUG

0.3% OPA-15406 Ointments; 1% OPA-15406 Ointments

Placebos DRUG

Placebo Ointments

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

You may not qualify if:

• Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
• Subjects who have an active viral skin infection.
• Subjects with a current or history of malignancy.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, 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

• Hiroaki Ono, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-06

Locations

JP (4)