Clinical trial NCT04979975: Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Recurrent Genital Herpes
Lead sponsor: UBP Greater China (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Age ≧18 years at the time of signing ICF
2. HSV-2 seropositive when screening
3. A history of recurrent genital herpes and experience 6-12 episodes in the past year
4. Negative result of the HIV assay
5. In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions
6. Keep daily diary during the study period
7. Female subjects: negative serum β-HCG at screening and no beast-feeding.
8. Use contraception during study participation
9. Understanding and willing to fully comply with study interventions and restrictions.

Exclusion Criteria:

1. 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).
2. History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases.
3. Use of systemic steroids or immunomodulators within 30 days prior to the screening
4. Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer.
5. Vaccination within 30 days prior to the screening.
6. Prior exposure to any HSV vaccines
7. Known hypersensitive to monoclonal antibodies
8. ECG abnormalities with clinical relevance or cardiovascular diseases at screening
9. Serum creatinine \> 1.5 mg/dL at screening
10. AST and ALT \> 2.5 x ULN at screening
11. HBsAg positive or HCT antibody positive at screening
12. Syphilis RPR test positive at screening
13. TB history or documented T-spot positive, or now is under treatment of TB
14. Any other circumstances that are determined to affect the conduct or successful completion of the clinical study

Primary outcomes:
measure: Time to first recurrence
timeFrame: 26 weeks
Secondary outcomes:
measure: Proportion of subjects with episodes
timeFrame: 26 weeks
measure: Lesion rate
timeFrame: 26 weeks
measure: Duration of recurrent lesions
timeFrame: 26 weeks
measure: Recurrence rate
timeFrame: 26 weeks
Other outcomes:
measure: HSV-2 shedding rate
timeFrame: 12 weeks
measure: Clinical and Subclinical HSV-2 Shedding Rates
timeFrame: 12 weeks
measure: Rate of HSV-2 Shedding Episodes
timeFrame: 12 weeks
measure: HSV-2 viral load
timeFrame: 12 weeks
Locations:
Study officials:
References: