Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
A Randomized, Single-blind, Placebo-control, Parallel, Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 3, 2022
September 1, 2022
2 years
July 19, 2021
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first recurrence
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
26 weeks
Secondary Outcomes (4)
Proportion of subjects with episodes
26 weeks
Lesion rate
26 weeks
Duration of recurrent lesions
26 weeks
Recurrence rate
26 weeks
Other Outcomes (4)
HSV-2 shedding rate
12 weeks
Clinical and Subclinical HSV-2 Shedding Rates
12 weeks
Rate of HSV-2 Shedding Episodes
12 weeks
- +1 more other outcomes
Study Arms (3)
Placebo
EXPERIMENTALplacebo matching UB-621
UB-621 low-dose
EXPERIMENTALlow-dose of UB-621
UB-621 high-dose
EXPERIMENTALhigh-dose of UB-621
Interventions
Eligibility Criteria
You may qualify if:
- Age ≧18 years at the time of signing ICF
- HSV-2 seropositive when screening
- A history of recurrent genital herpes and experience 6-12 episodes in the past year
- Negative result of the HIV assay
- In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions
- Keep daily diary during the study period
- Female subjects: negative serum β-HCG at screening and no beast-feeding.
- Use contraception during study participation
- Understanding and willing to fully comply with study interventions and restrictions.
You may not qualify if:
- Any medical conditions that may interfere the assessment of UB-621efficacy, or any medical conditions that may present symptoms in the anogenital regions (such as syphilis, genital warts).
- History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases.
- Use of systemic steroids or immunomodulators within 30 days prior to the screening
- Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer.
- Vaccination within 30 days prior to the screening.
- Prior exposure to any HSV vaccines
- Known hypersensitive to monoclonal antibodies
- ECG abnormalities with clinical relevance or cardiovascular diseases at screening
- Serum creatinine \> 1.5 mg/dL at screening
- AST and ALT \> 2.5 x ULN at screening
- HBsAg positive or HCT antibody positive at screening
- Syphilis RPR test positive at screening
- TB history or documented T-spot positive, or now is under treatment of TB
- Any other circumstances that are determined to affect the conduct or successful completion of the clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2021
First Posted
July 28, 2021
Study Start
December 1, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
October 3, 2022
Record last verified: 2022-09