Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Primary Purpose
Recurrent Genital Herpes
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
UB-621 low-dose
UB-621 high-dose
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Genital Herpes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Placebo
UB-621 low-dose
UB-621 high-dose
Arm Description
placebo matching UB-621
low-dose of UB-621
high-dose of UB-621
Outcomes
Primary Outcome Measures
Time to first recurrence
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
Secondary Outcome Measures
Proportion of subjects with episodes
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects.
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions.
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Full Information
NCT ID
NCT04979975
First Posted
July 19, 2021
Last Updated
September 29, 2022
Sponsor
UBP Greater China (Shanghai) Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04979975
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UBP Greater China (Shanghai) Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Genital Herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
placebo matching UB-621
Arm Title
UB-621 low-dose
Arm Type
Experimental
Arm Description
low-dose of UB-621
Arm Title
UB-621 high-dose
Arm Type
Experimental
Arm Description
high-dose of UB-621
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
PBO- placebo matching to UB-621
Intervention Type
Biological
Intervention Name(s)
UB-621 low-dose
Intervention Description
fully human anti-HSV mAb
Intervention Type
Biological
Intervention Name(s)
UB-621 high-dose
Intervention Description
fully human anti-HSV mAb
Primary Outcome Measure Information:
Title
Time to first recurrence
Description
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with episodes
Description
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects.
Time Frame
26 weeks
Title
Lesion rate
Description
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Time Frame
26 weeks
Title
Duration of recurrent lesions
Description
Duration of recurrent lesions is calculated as consecutive days with lesions.
Time Frame
26 weeks
Title
Recurrence rate
Description
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
HSV-2 shedding rate
Description
Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.
Time Frame
12 weeks
Title
Clinical and Subclinical HSV-2 Shedding Rates
Description
Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.
Time Frame
12 weeks
Title
Rate of HSV-2 Shedding Episodes
Description
The rate of HSV-2 shedding episodes is the number of onsets of shedding episodes divided by the total number of days with swabs collected. Shedding episodes are defined as consecutive HSV-2 positive swab results including no more than 1 consecutive negative result or missed swab. The episodes are preceded and followed by 2 consecutive negative swab results.
Time Frame
12 weeks
Title
HSV-2 viral load
Description
Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Shih, DVM
Phone
+886 36684800
Ext
3851
Email
linda.shih@unitedbiopharma.com
12. IPD Sharing Statement
Learn more about this trial
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
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