Trial Outcomes & Findings for Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis (NCT NCT03961529)
NCT ID: NCT03961529
Last Updated: 2021-11-19
Results Overview
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
366 participants
Primary outcome timeframe
Treatment period (52 weeks)
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
Adult: 1% OPA-15406 Ointment
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
Twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
166
|
144
|
56
|
|
Overall Study
COMPLETED
|
124
|
127
|
51
|
|
Overall Study
NOT COMPLETED
|
42
|
17
|
5
|
Reasons for withdrawal
| Measure |
Adult: 1% OPA-15406 Ointment
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
Twice daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
17
|
2
|
1
|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
7
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Other
|
6
|
1
|
0
|
Baseline Characteristics
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 Participants
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 Participants
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 Participants
Twice daily
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
7.1 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
8.3 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
166 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
366 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
166 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
366 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Treatment period (52 weeks)Population: Safety set: subjects who have received the IMP at least once
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Outcome measures
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 Participants
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 Participants
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 Participants
Twice daily
|
|---|---|---|---|
|
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
120 Participants
|
131 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Subjects who have received the IMP at least once and had IGA score at the baseline.
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.
Outcome measures
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 Participants
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 Participants
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 Participants
Twice daily
|
|---|---|---|---|
|
Responder Rate of Investigator's Global Assessment (IGA)
|
34.94 percentage of participants
Interval 27.71 to 42.71
|
52.78 percentage of participants
Interval 44.29 to 61.15
|
51.79 percentage of participants
Interval 38.03 to 65.34
|
SECONDARY outcome
Timeframe: Week 52Population: Subjects who have received the IMP at least once and had EASI score at the baseline.
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.
Outcome measures
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 Participants
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 Participants
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 Participants
Twice daily
|
|---|---|---|---|
|
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
|
55.42 percentage of participants
Interval 47.52 to 63.13
|
77.08 percentage of participants
Interval 69.35 to 83.67
|
64.29 percentage of participants
Interval 50.36 to 76.64
|
Adverse Events
Adult: 1% OPA-15406 Ointment
Serious events: 2 serious events
Other events: 72 other events
Deaths: 0 deaths
Pediatric: 0.3% OPA-15406 Ointment
Serious events: 1 serious events
Other events: 108 other events
Deaths: 0 deaths
Pediatric: 1% OPA-15406 Ointment
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 participants at risk
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 participants at risk
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 participants at risk
Twice daily
|
|---|---|---|---|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.60%
1/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.00%
0/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.00%
0/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.69%
1/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.00%
0/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.60%
1/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.00%
0/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
0.00%
0/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
Other adverse events
| Measure |
Adult: 1% OPA-15406 Ointment
n=166 participants at risk
Twice daily
|
Pediatric: 0.3% OPA-15406 Ointment
n=144 participants at risk
Twice daily
|
Pediatric: 1% OPA-15406 Ointment
n=56 participants at risk
Twice daily
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
3.0%
5/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
9.7%
14/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
12.5%
7/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.60%
1/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
6.2%
9/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
5.4%
3/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Folliculitis
|
6.0%
10/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
6.2%
9/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
8.9%
5/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
5/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
7.6%
11/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
10.7%
6/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Impetigo
|
1.2%
2/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
18.1%
26/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
8.9%
5/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Influenza
|
3.0%
5/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
14.6%
21/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
7.1%
4/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
4.9%
7/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
5.4%
3/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
14.5%
24/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
32.6%
47/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
30.4%
17/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
4.2%
6/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
7.1%
4/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.4%
4/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
4.9%
7/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
5.4%
3/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
21.1%
35/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
20.8%
30/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
30.4%
17/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.0%
5/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
6.2%
9/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
5.4%
3/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
8/166 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
9.7%
14/144 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
5.4%
3/56 • Treatment period (52 weeks)
Subjects who have received the IMP at least once were included in the safety analysis.
|
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