Back to resultsA Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis (AD)
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPA-15406
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis (AD)
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
Sites / Locations
- Sotobo Children's Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPA-15406
Arm Description
Outcomes
Primary Outcome Measures
Success rate in Investigator's Global Assessment (IGA)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05372653
First Posted
May 9, 2022
Last Updated
January 4, 2023
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05372653
Brief Title
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis (AD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OPA-15406
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPA-15406
Other Intervention Name(s)
difamilast
Intervention Description
0.3% or 1% ointment, topical, twice daily, for 52 weeks
Primary Outcome Measure Information:
Title
Success rate in Investigator's Global Assessment (IGA)
Description
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.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Sotobo Children's Clinic
City
Isumi
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
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