NCT02914548

Brief Summary

The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 29, 2020

Completed
Last Updated

July 23, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

September 8, 2016

Results QC Date

December 25, 2019

Last Update Submit

July 8, 2020

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

    The investigator or sub investigator assessed the skin symptoms using IGA. The investigator or sub investigator 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 Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.

    At Week 4

Secondary Outcomes (9)

  • 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

  • Change From Baseline in Percentage Affected Body Surface Area

    Baseline, Week 4

  • +4 more secondary outcomes

Study Arms (3)

0.3% OPA-15406

EXPERIMENTAL

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

Drug: OPA-15406

1% OPA-15406

EXPERIMENTAL

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

Drug: OPA-15406

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OPA-15406DRUG

Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.

0.3% OPA-154061% OPA-15406
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kiniki Region, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

difamilast

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune 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

September 8, 2016

First Posted

September 26, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 23, 2020

Results First Posted

June 29, 2020

Record last verified: 2020-06

Locations

JP(3)