Back to resultsA Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
Primary Purpose
Genital Herpes
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UB-621
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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 NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week 16.
- 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 prior to and upon the administration of study drug.
- 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.
- Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Placebo (volume equivalent to 2.5 mg/kg UB-621) 2.5 mg/kg UB-621
Placebo (volume equivalent to 5 mg/kg UB-621) 5 mg/kg UB-621
Outcomes
Primary Outcome Measures
change of HSV-2 shedding rate.
The primary endpoint for this study is to evaluate the reduction in HSV-2 shedding rate within subjects in the Baseline Period versus Follow-up Period.
Secondary Outcome Measures
change of HSV-2 viral load
Anogenital swab samples collected from subjects during the Baseline Period and Follow-up Period will be used to quantify HSV-2 DNA copies to evaluate efficacy of UB-621 in reducing viral load.
change of genital lesion rates
Subject self-assessment of genital lesions will be recorded in subject diary as daily routine tasks from Bv1 (Day B1) until Fv11/EOS visit (Day F140). Data from subject self-assessment of genital lesions will be used to evaluate the efficacy of UB-621 in reducing genital lesions rates. Genital lesion rate will be measured by the number of days with lesion(s) reported divided by the number of days of study periods (Baseline Period, Transition Period, or Follow-up Period).
Reduction in genital lesion rates will be evaluated before and after study drug treatment within subjects (Baseline versus Follow-up values).
Clinical and Subclinical HSV-2 Shedding Rates
Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the Baseline and Follow-up Periods will be used to evaluate the efficacy of UB-621 in reducing clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.
Rate of HSV-2 Shedding Episodes
Another secondary efficacy assessment includes the rate of HSV-2 shedding episodes as measured by 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.
Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the Baseline and Follow-up Periods will be used to evaluate the efficacy of UB-621 in reducing the rate of HSV-2 shedding episodes. Reduction in the rate of HSV-2 shedding episodes will be evaluated before and after study drug treatment within subjects (Baseline versus Follow-up values).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03595995
Brief Title
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
Official Title
A Two-Stage, Randomized, Double-Blind, Dose-Ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding 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
June 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United BioPharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.
Detailed Description
This is a 2-stage, randomized, double-blind, dose-ranging, multi-center phase 2 study designed to evaluate the efficacy, safety, and PK of UB-621 given at 2.5 or 5 mg/kg in adult subjects with recurrent genital HSV-2 infection. The study consists of 2 stages of enrollments, in which 40 subjects will be enrolled in the first stage and randomly assigned to receive placebo or UB-621 at 2.5 mg/kg in a 1:3 ratio into Cohort 1 at Bv6 (Day B57), and another 40 subjects will be enrolled in the second stage and randomly assigned to receive placebo or UB-621 at 5 mg/kg in a 1:3 ratio into Cohort 2 at Bv6 (Day B57) after review by the Data Safety Monitoring Committee (DSMC). The DSMC will review safety data after all subjects of Cohort 1 complete the visit Fv6 (Day F28) and make the recommendation whether to proceed with enrollment for Cohort 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Placebo (volume equivalent to 2.5 mg/kg UB-621)
2.5 mg/kg UB-621
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Placebo (volume equivalent to 5 mg/kg UB-621)
5 mg/kg UB-621
Intervention Type
Biological
Intervention Name(s)
UB-621
Intervention Description
Monoclonal antibody by SC injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.
Primary Outcome Measure Information:
Title
change of HSV-2 shedding rate.
Description
The primary endpoint for this study is to evaluate the reduction in HSV-2 shedding rate within subjects in the Baseline Period versus Follow-up Period.
Time Frame
112 days
Secondary Outcome Measure Information:
Title
change of HSV-2 viral load
Description
Anogenital swab samples collected from subjects during the Baseline Period and Follow-up Period will be used to quantify HSV-2 DNA copies to evaluate efficacy of UB-621 in reducing viral load.
Time Frame
112 days
Title
change of genital lesion rates
Description
Subject self-assessment of genital lesions will be recorded in subject diary as daily routine tasks from Bv1 (Day B1) until Fv11/EOS visit (Day F140). Data from subject self-assessment of genital lesions will be used to evaluate the efficacy of UB-621 in reducing genital lesions rates. Genital lesion rate will be measured by the number of days with lesion(s) reported divided by the number of days of study periods (Baseline Period, Transition Period, or Follow-up Period).
Reduction in genital lesion rates will be evaluated before and after study drug treatment within subjects (Baseline versus Follow-up values).
Time Frame
140 days
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 Baseline and Follow-up Periods will be used to evaluate the efficacy of UB-621 in reducing clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.
Time Frame
196 days
Title
Rate of HSV-2 Shedding Episodes
Description
Another secondary efficacy assessment includes the rate of HSV-2 shedding episodes as measured by 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.
Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the Baseline and Follow-up Periods will be used to evaluate the efficacy of UB-621 in reducing the rate of HSV-2 shedding episodes. Reduction in the rate of HSV-2 shedding episodes will be evaluated before and after study drug treatment within subjects (Baseline versus Follow-up values).
Time Frame
196
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week 16.
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 prior to and upon the administration of study drug.
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.
Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Lai
Phone
+886-3-668-4800
Email
annie.lai@unitedbiopharma.com
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
We'll reach out to this number within 24 hrs