Trial Outcomes & Findings for Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (NCT NCT03911401)

Results Overview

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 4. 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

251 participants

Primary outcome timeframe

At Week 4

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	0.3% OPA-15406 Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Overall Study STARTED	83	85	83
Overall Study COMPLETED	76	76	58
Overall Study NOT COMPLETED	7	9	25

Reasons for withdrawal

Reasons for withdrawal
Measure	0.3% OPA-15406 Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Overall Study Adverse Event	1	2	5
Overall Study Lack of Efficacy	1	1	8
Overall Study Physician Decision	0	0	1
Overall Study Withdrawal by Subject	1	2	0
Overall Study Withdrawal by parent/guardian	4	4	11

Baseline Characteristics

Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.3% OPA-15406 n=83 Participants Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 n=85 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=83 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.	Total n=251 Participants Total of all reporting groups
Age, Continuous	7.1 years STANDARD_DEVIATION 3.3 • n=39 Participants	7.2 years STANDARD_DEVIATION 3.2 • n=41 Participants	7.1 years STANDARD_DEVIATION 2.8 • n=35 Participants	7.1 years STANDARD_DEVIATION 3.1 • n=31 Participants
Sex: Female, Male Female	45 Participants n=39 Participants	37 Participants n=41 Participants	34 Participants n=35 Participants	116 Participants n=31 Participants
Sex: Female, Male Male	38 Participants n=39 Participants	48 Participants n=41 Participants	49 Participants n=35 Participants	135 Participants n=31 Participants
Race/Ethnicity, Customized Asian	83 Participants n=39 Participants	85 Participants n=41 Participants	83 Participants n=35 Participants	251 Participants n=31 Participants
Region of Enrollment Japan	83 Participants n=39 Participants	85 Participants n=41 Participants	83 Participants n=35 Participants	251 Participants n=31 Participants

PRIMARY outcome

Timeframe: At Week 4

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 4. 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.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 n=83 Participants Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 n=85 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=83 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity	44.58 percentage of participants Interval 33.66 to 55.9	47.06 percentage of participants Interval 36.13 to 58.19	18.07 percentage of participants Interval 10.48 to 28.05

SECONDARY outcome

Timeframe: Baseline, Week 4

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, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) 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). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 n=77 Participants Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 n=77 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=59 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Change From Baseline in Eczema Area and Severity Index (EASI) Score	-4.97 score on a scale Standard Error 0.84	-6.07 score on a scale Standard Error 0.84	0.35 score on a scale Standard Error 0.90

SECONDARY outcome

Timeframe: Baseline, Week 4

The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None 1. : Mild 2. : Moderate 3. : Severe For subjects aged 2 to 6 years, this would not be evaluated. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 n=38 Participants Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 n=41 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=33 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score	-0.80 score on a scale Standard Error 0.12	-0.68 score on a scale Standard Error 0.12	-0.33 score on a scale Standard Error 0.13

Adverse Events

0.3% OPA-15406

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

1% OPA-15406

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.3% OPA-15406 n=83 participants at risk Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	1% OPA-15406 n=85 participants at risk Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=83 participants at risk Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Infections and infestations Impetigo	7.2% 6/83 • Treatment period (4 weeks)	2.4% 2/85 • Treatment period (4 weeks)	6.0% 5/83 • Treatment period (4 weeks)
Infections and infestations Nasopharyngitis	6.0% 5/83 • Treatment period (4 weeks)	8.2% 7/85 • Treatment period (4 weeks)	3.6% 3/83 • Treatment period (4 weeks)

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place