Atopic Dermatitis
Conditions
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.
Interventions
Twice daily
Twice daily
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | Treatment period (52 weeks) | The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate of Investigator's Global Assessment (IGA) | Week 52 | 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) | Week 52 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult: 1% OPA-15406 Ointment Twice daily | 166 |
| Pediatric: 0.3% OPA-15406 Ointment Twice daily | 144 |
| Pediatric: 1% OPA-15406 Ointment Twice daily | 56 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 5 | 2 |
| Overall Study | Lack of Efficacy | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 |
| Overall Study | Other | 6 | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 1 |
| Overall Study | Withdrawal by parent/guardian | 0 | 7 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 2 | 1 |
Baseline characteristics
| Characteristic | Adult: 1% OPA-15406 Ointment | Pediatric: 0.3% OPA-15406 Ointment | Pediatric: 1% OPA-15406 Ointment | Total |
|---|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 11.3 | 7.1 years STANDARD_DEVIATION 3.5 | 8.3 years STANDARD_DEVIATION 3.5 | 7.4 years STANDARD_DEVIATION 3.5 |
| Race/Ethnicity, Customized Asian | 166 Participants | 144 Participants | 56 Participants | 366 Participants |
| Region of Enrollment Japan | 166 Participants | 144 Participants | 56 Participants | 366 Participants |
| Sex: Female, Male Female | 65 Participants | 63 Participants | 18 Participants | 146 Participants |
| Sex: Female, Male Male | 101 Participants | 81 Participants | 38 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 144 | 0 / 56 |
| other Total, other adverse events | 72 / 166 | 108 / 144 | 43 / 56 |
| serious Total, serious adverse events | 2 / 166 | 1 / 144 | 0 / 56 |
Outcome results
Primary
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Time frame: Treatment period (52 weeks)
Population: Safety set: subjects who have received the IMP at least once
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult: 1% OPA-15406 Ointment | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | 120 Participants |
| Pediatric: 0.3% OPA-15406 Ointment | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | 131 Participants |
| Pediatric: 1% OPA-15406 Ointment | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | 47 Participants |
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.
Time frame: Week 52
Population: Subjects who have received the IMP at least once and had EASI score at the baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult: 1% OPA-15406 Ointment | Responder Rate of Eczema Area and Severity Index 75 (EASI 75) | 55.42 percentage of participants |
| Pediatric: 0.3% OPA-15406 Ointment | Responder Rate of Eczema Area and Severity Index 75 (EASI 75) | 77.08 percentage of participants |
| Pediatric: 1% OPA-15406 Ointment | Responder Rate of Eczema Area and Severity Index 75 (EASI 75) | 64.29 percentage of participants |
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.
Time frame: Week 52
Population: Subjects who have received the IMP at least once and had IGA score at the baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult: 1% OPA-15406 Ointment | Responder Rate of Investigator's Global Assessment (IGA) | 34.94 percentage of participants |
| Pediatric: 0.3% OPA-15406 Ointment | Responder Rate of Investigator's Global Assessment (IGA) | 52.78 percentage of participants |
| Pediatric: 1% OPA-15406 Ointment | Responder Rate of Investigator's Global Assessment (IGA) | 51.79 percentage of participants |