Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, UB-621 low-dose, UB-621 high-dose.
- Who it may be relevant to
- Registry conditions: Recurrent Genital Herpes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Other Placebo
PBO- placebo matching to UB-621 - Biological UB-621 low-dose
fully human anti-HSV mAb - Biological UB-621 high-dose
fully human anti-HSV mAb
Primary outcome measures
- Time to first recurrence [Time frame: 26 weeks]
Secondary outcome measures (4)
- Proportion of subjects with episodes [Time frame: 26 weeks]
- Lesion rate [Time frame: 26 weeks]
- Duration of recurrent lesions [Time frame: 26 weeks]
- Recurrence rate [Time frame: 26 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04979975 · UBP-A229-HSV