Back to resultsLong-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
0.3% OPA-15406 ointment
1% OPA-15406 ointment
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- 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
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
- Shirao clinic of pediatrics and pediatric allergy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0.3% OPA-15406 ointment
1% OPA-15406 ointment
Arm Description
Twice daily
Twice daily
Outcomes
Primary Outcome Measures
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Secondary Outcome Measures
Responder Rate of 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 52.
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.
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs).
EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.
Full Information
NCT ID
NCT03961529
First Posted
April 26, 2019
Last Updated
October 21, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03961529
Brief Title
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Official Title
A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.3% OPA-15406 ointment
Arm Type
Experimental
Arm Description
Twice daily
Arm Title
1% OPA-15406 ointment
Arm Type
Experimental
Arm Description
Twice daily
Intervention Type
Drug
Intervention Name(s)
0.3% OPA-15406 ointment
Intervention Description
Twice daily
Intervention Type
Drug
Intervention Name(s)
1% OPA-15406 ointment
Intervention Description
Twice daily
Primary Outcome Measure Information:
Title
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Description
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Time Frame
Treatment period (52 weeks)
Secondary Outcome Measure Information:
Title
Responder Rate of 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 52.
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 52
Title
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
Description
The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs).
EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Osamu Sato
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Shirao clinic of pediatrics and pediatric allergy
City
Hiroshima
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.
Citations:
PubMed Identifier
35716332
Citation
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.
Results Reference
derived
Learn more about this trial
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
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