Trial Outcomes & Findings for Phase III Study of ASP2151 in Herpes Simplex Patients (NCT NCT01959295)
NCT ID: NCT01959295
Last Updated: 2024-10-09
Results Overview
The percentage of participants achieving lesion healing by Day 8 of study treatment
COMPLETED
PHASE3
468 participants
8days
2024-10-09
Participant Flow
Participant milestones
| Measure |
ASP2151
200 mg once daily
|
ASP2151 Placebo
ASP2151 placebo once daily
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
157
|
|
Overall Study
COMPLETED
|
278
|
140
|
|
Overall Study
NOT COMPLETED
|
33
|
17
|
Reasons for withdrawal
| Measure |
ASP2151
200 mg once daily
|
ASP2151 Placebo
ASP2151 placebo once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Protocol Violation
|
16
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Clinical laboratory value is ineligible on day 1
|
10
|
6
|
Baseline Characteristics
Phase III Study of ASP2151 in Herpes Simplex Patients
Baseline characteristics by cohort
| Measure |
ASP2151
n=307 Participants
200mg once daily
|
ASP2151 Placebo
n=154 Participants
ASP2151 placebo once daily
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
287 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
434 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
40.5 years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
40.4 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
326 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
307 participants
n=99 Participants
|
154 participants
n=107 Participants
|
461 participants
n=206 Participants
|
|
Disease type
Labial/facial herpes
|
264 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
397 Participants
n=206 Participants
|
|
Disease type
Recurrent genital herpes
|
43 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8daysPopulation: The full analysis set (FAS). The FAS 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=307 Participants
ASP2151: 200 mg once daily
|
ASP2151 Placebo
n=154 Participants
ASP2151 placebo: once daily
|
|---|---|---|
|
Percentage of Participants With Healing by Day 8
|
66.4 Percentage of Participants
|
69.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: 29daysPopulation: The full analysis set (FAS). The FAS 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=307 Participants
ASP2151: 200 mg once daily
|
ASP2151 Placebo
n=154 Participants
ASP2151 placebo: once daily
|
|---|---|---|
|
Time to Healing
|
8 day
Interval 6.0 to 9.0
|
8 day
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: 29daysPopulation: The full analysis set (FAS). The FAS 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=307 Participants
ASP2151: 200 mg once daily
|
ASP2151 Placebo
n=154 Participants
ASP2151 placebo: once daily
|
|---|---|---|
|
Time to Complete Crusting
|
6 day
Interval 5.0 to 8.0
|
6 day
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: 29daysPopulation: The full analysis set (FAS). The FAS 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=307 Participants
ASP2151: 200 mg once daily
|
ASP2151 Placebo
n=154 Participants
ASP2151 placebo: once daily
|
|---|---|---|
|
Time to Virus Disappearance
|
4 day
Interval 3.0 to 6.0
|
5 day
Interval 4.0 to 6.0
|
Adverse Events
ASP2151
ASP2151 Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASP2151
n=309 participants at risk
200 mg once daily
|
ASP2151 Placebo
n=157 participants at risk
ASP2151 placebo once daily
|
|---|---|---|
|
Infections and infestations
Genital herpes
|
3.6%
11/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
1.9%
3/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
15/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
3.2%
5/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Infections and infestations
Oral herpes
|
4.2%
13/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
5.1%
8/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
2.9%
9/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
1.3%
2/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.97%
3/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
2.5%
4/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Investigations
Fibrin degradation products increased
|
4.2%
13/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
2.5%
4/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
|
Investigations
Alpha 1 microglobulin increased
|
7.4%
23/309 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
3.2%
5/157 • 29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug. The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
|
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