UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals
Primary Purpose
Recurrent Genital Herpes
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UB-621
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Genital Herpes
Eligibility Criteria
Inclusion Criteria:
- Subject must be at least 18 years of age inclusive.
- Subject must be HSV-2 seropositive
- Subjects have a history of recurrent genital herpes in the past year
- Subjects have a negative result on the HIV Ab/Ag assay
- Subjects must agree to use contraception during study participation
- Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks period after the administration of study drug.
- Subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area.
- Subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the HSV lesion score, and to record in the patient dairy
- Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.
Exclusion Criteria:
- Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.
- History or current evidence of malignancy except for a localized non-melanoma skin cancer
- Known immunosuppression
- Exposure to HSV vaccine
- Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
- Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
- Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
- Renal impairment and/or hepatic impairment
- ECG abnormalities of clinical relevance or cardiovascular conditions
Abnormal blood tests according to "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial "in the Guidance for Industry, 2007:
- albumin<3 g/dl
- ALP>2.5*ULN
- ALT>2.5*ULN
- AST>2.5*ULN
- Bilirubin>1.5*ULN
- CPK>1.5*ULN
- rGGT>2.5*ULN
- Hemoglobin: female<11 g/dl; male<12.5 g/dl
- platelet<125*10E3/ul
- WBC<2.5*10E3/ul or
- ANC<1.5*10E3/ul
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cohort 1
cohort 2
Arm Description
2.5 mg/kg UB-621 group
5 mg/kg UB-621 group
Outcomes
Primary Outcome Measures
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. Primary endpoint is the self-comparison of proportion of subjects with episodes before and after UB-621 treatment.
Secondary Outcome Measures
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 of HSV score 2-7.
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time to first recurrence of lesion
Time to first recurrence of lesion as reported by patient and verified by investigator.
Full Information
NCT ID
NCT04714060
First Posted
January 15, 2021
Last Updated
May 16, 2022
Sponsor
UBP Greater China (Shanghai) Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04714060
Brief Title
UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals
Official Title
A Randomized, Single-blind, Dose-selected 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
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (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
A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cohort 1
Arm Type
Experimental
Arm Description
2.5 mg/kg UB-621 group
Arm Title
cohort 2
Arm Type
Experimental
Arm Description
5 mg/kg UB-621 group
Intervention Type
Biological
Intervention Name(s)
UB-621
Intervention Description
mAb by SC administration
Primary Outcome Measure Information:
Title
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
Description
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. Primary endpoint is the self-comparison of proportion of subjects with episodes before and after UB-621 treatment.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Lesion rate
Description
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Time Frame
16 weeks
Title
Duration of recurrent lesions
Description
Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
Time Frame
16 weeks
Title
Recurrence rate
Description
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time Frame
16 weeks
Title
Time to first recurrence of lesion
Description
Time to first recurrence of lesion as reported by patient and verified by investigator.
Time Frame
16 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
8 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
8 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
8 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
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be at least 18 years of age inclusive.
Subject must be HSV-2 seropositive
Subjects have a history of recurrent genital herpes in the past year
Subjects have a negative result on the HIV Ab/Ag assay
Subjects must agree to use contraception during study participation
Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks period after the administration of study drug.
Subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area.
Subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the HSV lesion score, and to record in the patient dairy
Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.
Exclusion Criteria:
Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.
History or current evidence of malignancy except for a localized non-melanoma skin cancer
Known immunosuppression
Exposure to HSV vaccine
Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
Renal impairment and/or hepatic impairment
ECG abnormalities of clinical relevance or cardiovascular conditions
Abnormal blood tests according to "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial "in the Guidance for Industry, 2007:
albumin<3 g/dl
ALP>2.5*ULN
ALT>2.5*ULN
AST>2.5*ULN
Bilirubin>1.5*ULN
CPK>1.5*ULN
rGGT>2.5*ULN
Hemoglobin: female<11 g/dl; male<12.5 g/dl
platelet<125*10E3/ul
WBC<2.5*10E3/ul or
ANC<1.5*10E3/ul
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
Plan to Share IPD
No
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UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals
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