Atopic Dermatitis (AD)
Conditions
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
Interventions
DRUGOPA-15406
0.3% or 1% ointment, topical, twice daily, for 52 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | Week4 | Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 29 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Study treatment terminated by parent/guardian | 1 | 3 |
Baseline characteristics
| Characteristic | Total | 0.3% OPA-15406 | 1% OPA-15406 |
|---|---|---|---|
| Age, Continuous | 10.0 Months STANDARD_DEVIATION 5.1 | 7.9 Months STANDARD_DEVIATION 3.9 | 10.8 Months STANDARD_DEVIATION 5.4 |
| Age, Customized Age Group <12 months | 28 Participants | 10 Participants | 18 Participants |
| Age, Customized Age Group >=12 months | 13 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Japanese | 41 Participants | 12 Participants | 29 Participants |
| Region of Enrollment Japan | 41 participants | 12 participants | 29 participants |
| Sex: Female, Male Female | 15 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 26 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 29 |
| other Total, other adverse events | 24 / 41 | 29 / 29 |
| serious Total, serious adverse events | 1 / 41 | 1 / 29 |
Outcome results
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.
Time frame: Week 4
Population: The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.3% OPA-15406 | Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | 56.10 Percentage of perticipants |
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.
Time frame: Week4
Population: The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.3% OPA-15406 | Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | 82.93 Percentage of perticipants |