Trial Outcomes & Findings for Open-label Study of ASP2151 in Herpes Simplex Patients (NCT NCT02209324)
NCT ID: NCT02209324
Last Updated: 2024-09-27
Results Overview
The percentage of participants achieving lesion healing by Day 8 of study treatment
COMPLETED
PHASE3
275 participants
8 days
2024-09-27
Participant Flow
Participant milestones
| Measure |
ASP2151
200mg once daily
|
|---|---|
|
Overall Study
STARTED
|
275
|
|
Overall Study
COMPLETED
|
230
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
ASP2151
200mg once daily
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
14
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Clinical laboratory value is ineligible on day 1
|
4
|
|
Overall Study
Platelet count < LLN in Laboratory test
|
7
|
|
Overall Study
QT interval >-450 ms on measurement of an ECG
|
5
|
Baseline Characteristics
Open-label Study of ASP2151 in Herpes Simplex Patients
Baseline characteristics by cohort
| Measure |
ASP2151
n=265 Participants
200mg once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
247 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
39.2 year
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
265 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
265 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
265 participants
n=5 Participants
|
|
Disease type
Recurrent labial / facial herpes
|
191 Participants
n=5 Participants
|
|
Disease type
Recurrent genital herpes
|
39 Participants
n=5 Participants
|
|
Disease type
Kaposi varicelliform eruption
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 daysPopulation: Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.
The percentage of participants achieving lesion healing by Day 8 of study treatment
Outcome measures
| Measure |
ASP2151
n=265 Participants
200mg once daily
|
|---|---|
|
Percentage of Participants With Healing by Day 8
|
194 Participants
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.
The criteria for determining healing are as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved. 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
Outcome measures
| Measure |
ASP2151
n=265 Participants
200mg once daily
|
|---|---|
|
Time to Healing
|
7 day
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.
The criteria for complete crust formation are outlined as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required). 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
Outcome measures
| Measure |
ASP2151
n=265 Participants
200mg once daily
|
|---|---|
|
Time to Complete Crusting
|
6 day
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.
The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site.
Outcome measures
| Measure |
ASP2151
n=265 Participants
200mg once daily
|
|---|---|
|
Time to Virus Disappearance
|
5 day
Interval 3.0 to 6.0
|
Adverse Events
ASP2151
Serious adverse events
| Measure |
ASP2151
n=271 participants at risk
200mg once daily
|
|---|---|
|
Infections and infestations
Cellulitis of male external genitalorgan
|
0.37%
1/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.37%
1/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
Other adverse events
| Measure |
ASP2151
n=271 participants at risk
200mg once daily
|
|---|---|
|
Gastrointestinal disorders
Stomatitis
|
2.2%
6/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
11/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
|
Infections and infestations
Folliculitis
|
2.2%
6/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
|
Investigations
Fibrin degradation products increased
|
7.7%
21/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
|
Investigations
Alpha 1 microglobulin increased
|
4.8%
13/271 • 29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
|
Additional Information
Maruho Co.,Ltd. Kyoto R&D Center
Clinical Development Dept.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place