- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03595995
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Annie Lai
- Phone Number: +886-3-668-4800
- Email: annie.lai@unitedbiopharma.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
|
Monoclonal antibody by SC injection
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.
|
Experimental: Cohort 2
|
Monoclonal antibody by SC injection
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of HSV-2 shedding rate.
Time Frame: 112 days
|
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.
|
112 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of HSV-2 viral load
Time Frame: 112 days
|
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.
|
112 days
|
change of genital lesion rates
Time Frame: 140 days
|
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). |
140 days
|
Clinical and Subclinical HSV-2 Shedding Rates
Time Frame: 196 days
|
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.
|
196 days
|
Rate of HSV-2 Shedding Episodes
Time Frame: 196
|
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). |
196
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBP-A206-HSV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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