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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPA-15406 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPA-15406 | Drug | 0.3% or 1% ointment, topical, twice daily, for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). 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 Week 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI. | Week4 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sotobo Children's Clinic | Isumi | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41171590 | Derived | Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan;16(1):339-352. doi: 10.1007/s13555-025-01581-1. Epub 2025 Oct 31. | |
| 39075274 | Derived |
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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.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% OPA-15406 | The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) for 52 weeks. |
| FG001 | 1% OPA-15406 | As the starting dose, the 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . After 4 weeks of the IMP administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% OPA-15406 | The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) for 52 weeks. |
| BG001 | 1% OPA-15406 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). 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 Week 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline. | The efficacy analysis set (FAS [full analysis set]) consisted of all subjects who received the IMP at least once. | Posted | Number | 95% Confidence Interval | Percentage of perticipants | Week 4 |
|
Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once.
The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.3% OPA-15406 | The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . In this section, we display the adverse events that occurred at the time of administration of the 0.3% formulation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Vascular disorders | MedDRA Ver. 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81363617366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2024 | Nov 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C000711049 | difamilast |
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| Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. An Interim Report of a Phase 3, Long-Term, Open-Label Study to Evaluate Efficacy and Safety of Difamilast Ointment in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2443-2455. doi: 10.1007/s13555-024-01236-7. Epub 2024 Jul 29. |
As the starting dose, the 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . After 4 weeks of the IMP administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI. | The efficacy analysis set (FAS [full analysis set]) consisted of all subjects who received the IMP at least once. | Posted | Number | 95% Confidence Interval | Percentage of perticipants | Week4 |
|
|
|
| 0 |
| 41 |
| 1 |
| 41 |
| 24 |
| 41 |
| EG001 | 1% OPA-15406 | After 4 weeks of the 0.3% formulation administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase. In this section, we display the adverse events that occurred at the time of administration of the 1.0% formulation. | 0 | 29 | 1 | 29 | 29 | 29 |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA Ver. 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 26.1 | Non-systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |