Trial Outcomes & Findings for Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome (NCT NCT03908970)

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

364 participants

Primary outcome timeframe

At Week 4

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	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	182	182
Overall Study COMPLETED	165	135
Overall Study NOT COMPLETED	17	47

Reasons for withdrawal

Reasons for withdrawal
Measure	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	7	21
Overall Study Physician Decision	1	4
Overall Study Withdrawal by Subject	9	22

Baseline Characteristics

Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1% OPA-15406 n=182 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=182 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.	Total n=364 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	32.1 years STANDARD_DEVIATION 10.6 • n=7 Participants	31.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	81 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	101 Participants n=7 Participants	197 Participants n=5 Participants
Race/Ethnicity, Customized Asian	182 Participants n=5 Participants	182 Participants n=7 Participants	364 Participants n=5 Participants
Region of Enrollment Japan	182 Participants n=5 Participants	182 Participants n=7 Participants	364 Participants n=5 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	1% OPA-15406 n=182 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=182 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity	38.46 percentage of perticipants Interval 31.36 to 45.95	12.64 percentage of perticipants Interval 8.18 to 18.36

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

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).

Outcome measures

Outcome measures
Measure	1% OPA-15406 n=166 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=134 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Change From Baseline in Eczema Area and Severity Index (EASI) Score	-4.17 score on a scale Standard Error 0.50	-0.08 score on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects 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

Outcome measures

Outcome measures
Measure	1% OPA-15406 n=166 Participants Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=134 Participants Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score	-0.65 score on a scale Standard Error 0.06	-0.04 score on a scale Standard Error 0.07

Adverse Events

1% OPA-15406

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1% OPA-15406 n=182 participants at risk Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Placebo n=182 participants at risk Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Skin and subcutaneous tissue disorders Dermatitis atopic	3.8% 7/182 • Treatment period (4 weeks)	12.1% 22/182 • 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