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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% OPA-15406 ointment | Experimental | Twice daily |
|
| 1% OPA-15406 ointment | Experimental | Twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% OPA-15406 ointment | Drug | Twice daily |
| |
| 1% OPA-15406 ointment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs). | Treatment period (52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|
| Osamu Sato | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirao clinic of pediatrics and pediatric allergy | Hiroshima | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35716332 | Derived | 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. |
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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 | Adult: 1% OPA-15406 Ointment | Twice daily |
| FG001 | Pediatric: 0.3% OPA-15406 Ointment | Twice daily |
| FG002 | Pediatric: 1% OPA-15406 Ointment | Twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: subjects who have received the investigational medicinal product (IMP) at least once
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult: 1% OPA-15406 Ointment | Twice daily |
| BG001 | Pediatric: 0.3% OPA-15406 Ointment | Twice daily |
| 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 | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs). | Safety set: subjects who have received the IMP at least once | Posted | Count of Participants | Participants | Treatment period (52 weeks) |
|
Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
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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 | Adult: 1% OPA-15406 Ointment | Twice daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA Ver. 22.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA Ver. 22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | 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 | Yes | No | No | Study Protocol | Feb 1, 2019 | Oct 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2020 | Oct 7, 2021 | SAP_001.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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| Drug |
Twice daily |
|
| Week 52 |
| 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. | Week 52 |
| Withdrawal by parent/guardian |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Other |
|
| BG002 |
| Pediatric: 1% OPA-15406 Ointment |
Twice daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Twice daily |
|
|
| Secondary | 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. | Subjects who have received the IMP at least once and had IGA score at the baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
|
|
| Secondary | 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. | Subjects who have received the IMP at least once and had EASI score at the baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
|
|
| 166 |
| 2 |
| 166 |
| 72 |
| 166 |
| EG001 | Pediatric: 0.3% OPA-15406 Ointment | Twice daily | 0 | 144 | 1 | 144 | 108 | 144 |
| EG002 | Pediatric: 1% OPA-15406 Ointment | Twice daily | 0 | 56 | 0 | 56 | 43 | 56 |
| Pneumonia bacterial | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.1 | 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 |