Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis (NCT NCT02068352)
NCT ID: NCT02068352
Last Updated: 2021-11-23
Results Overview
The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
COMPLETED
PHASE2
121 participants
Week 4
2021-11-23
Participant Flow
Participants took part in the study at 30 investigative sites in Australia, Poland, and the United States from 20 June 2014 to 28 January 2015.
Participants with mild/moderate atopic dermatitis were randomized in 1:1:1 ratio to receive OPA 15406 (3% w/w, 1% w/w) and matching placebo. Participants had screening evaluations between 30 and 2 days before entering the 8-week treatment phase.
Participant milestones
| Measure |
0.3% OPA-15406
OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
37
|
|
Overall Study
COMPLETED
|
31
|
35
|
28
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
9
|
Reasons for withdrawal
| Measure |
0.3% OPA-15406
OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
4
|
2
|
7
|
|
Overall Study
Participant met (Protocol Specified) Withdrawal Criteria
|
0
|
1
|
0
|
|
Overall Study
Participant Withdrew Consent to Participate
|
6
|
3
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from Baseline.
The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
LOCF
|
15.00 percentage of participants
|
20.93 percentage of participants
|
2.70 percentage of participants
|
|
Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
Non-responders
|
14.63 percentage of participants
|
20.93 percentage of participants
|
2.70 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Efficacy Sample included all randomized participants who received at least one dose of study treatment. Overall number analyzed is the number of participants with non-missing assessment at a specific visit.
The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score.
Outcome measures
| Measure |
0.3% OPA-15406
n=35 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=40 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=29 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
|
-0.56 score on a scale
Standard Error 0.14
|
-0.55 score on a scale
Standard Error 0.13
|
-0.09 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Overall number analyzed is the number of participants with non-missing assessment at a specific visit.
The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score.
Outcome measures
| Measure |
0.3% OPA-15406
n=40 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
|
-0.54 score on a scale
Standard Error 0.15
|
-0.54 score on a scale
Standard Error 0.14
|
-0.04 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: From signing of informed consent through Week 8Population: Safety Sample included all participants who received at least one dose of IMP.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Participants With Treatment Site AEs
|
26.8 percentage of participants
|
11.6 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Participants With Treatment-emergent AEs (TEAEs)
|
58.5 percentage of participants
|
41.9 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Participants With Serious TEAEs
|
4.9 percentage of participants
|
4.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Participants With Severe TEAEs
|
12.2 percentage of participants
|
4.7 percentage of participants
|
8.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Participants With Severe Treatment Site TEAEs
|
4.9 percentage of participants
|
0.0 percentage of participants
|
5.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 8Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from Baseline.
IGA evaluation was performed by a certified rater. The IGA consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. In the primary analysis, participants without IGA score available at Week 8 were treated as non-responders. In the sensitivity analysis, the missing IGA score at Week 8 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation)
Non-responders
|
17.07 percentage of participants
|
16.28 percentage of participants
|
10.81 percentage of participants
|
|
Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation)
LOCF
|
20.00 percentage of participants
|
20.93 percentage of participants
|
10.81 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit.
The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis)
Change at Week 4
|
-2.21 score on a scale
Standard Error 0.85
|
-3.19 score on a scale
Standard Error 0.80
|
-1.10 score on a scale
Standard Error 0.90
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis)
Change at Week 8
|
-2.60 score on a scale
Standard Error 0.90
|
-3.47 score on a scale
Standard Error 0.86
|
-1.57 score on a scale
Standard Error 0.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit.
The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in EASI Score (Using LOCF Analysis)
Change at Week 8
|
-2.42 score on a scale
Standard Error 1.01
|
-3.36 score on a scale
Standard Error 0.96
|
-1.00 score on a scale
Standard Error 1.02
|
|
Change From Baseline in EASI Score (Using LOCF Analysis)
Change at Week 4
|
-2.00 score on a scale
Standard Error 0.91
|
-3.07 score on a scale
Standard Error 0.87
|
-0.51 score on a scale
Standard Error 0.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit.
At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas\[s\] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis)
Change at Week 4
|
-6.27 units on scale
Standard Error 4.67
|
-16.71 units on scale
Standard Error 4.40
|
-4.87 units on scale
Standard Error 4.96
|
|
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis)
Change at Week 8
|
-10.98 units on scale
Standard Error 5.12
|
-20.71 units on scale
Standard Error 4.85
|
-7.30 units on scale
Standard Error 5.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit.
At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas\[s\] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 Participants
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 Participants
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in VAS for Pruritus (Using LOCF Analysis)
Change at Week 4
|
-4.05 units on a scale
Standard Error 4.92
|
-14.59 units on a scale
Standard Error 4.64
|
-3.05 units on a scale
Standard Error 4.96
|
|
Change From Baseline in VAS for Pruritus (Using LOCF Analysis)
Change at Week 8
|
-10.01 units on a scale
Standard Error 5.51
|
-20.33 units on a scale
Standard Error 5.20
|
-7.28 units on a scale
Standard Error 5.56
|
Adverse Events
0.3% OPA-15406
1% OPA-15406
Vehicle Ointment
Serious adverse events
| Measure |
0.3% OPA-15406
n=41 participants at risk
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 participants at risk
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 participants at risk
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
Giardiasis
|
0.00%
0/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.3%
1/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Investigations
Liver function test abnormal
|
2.4%
1/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Nervous system disorders
Multiple sclerosis
|
2.4%
1/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.3%
1/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
Other adverse events
| Measure |
0.3% OPA-15406
n=41 participants at risk
OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
1% OPA-15406
n=43 participants at risk
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
Vehicle Ointment
n=37 participants at risk
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.3%
1/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
5.4%
2/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.3%
1/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
8.1%
3/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.3%
1/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
5.4%
2/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Nervous system disorders
Headache
|
4.9%
2/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
7.0%
3/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
26.8%
11/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
16.3%
7/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
21.6%
8/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
3/41 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
0.00%
0/43 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
2.7%
1/37 • From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER