Genital HerpesPhase 2NCT03595995
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
A Phase 2 study testing UB-621 in people with Genital Herpes, run by United BioPharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Herpes
- What is being tested?
- UB-621
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Genital Herpes
- Being tested
- UB-621, Placebo
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-621Biological
Monoclonal antibody by SC injection
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1. Placebo (volume equivalent to 2.5 mg/kg UB-621)
2. 2.5 mg/kg UB-621 Receives: Biological: UB-621; Other: Placebo |
| Cohort 2 | Experimental | 1. Placebo (volume equivalent to 5 mg/kg UB-621)
2. 5 mg/kg UB-621 Receives: Biological: UB-621; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 112 days
Secondary outcomes (4)
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.
Measured: 112 days
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).
Measured: 140 days
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.
Measured: 196 days
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).
Measured: 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jun 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595995
- Sponsor's protocol ID
- UBP-A206-HSV
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2018
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03595995
- Acronym / sponsor ID
- UBP-A206-HSV
- Conditions
- Genital Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: UB-621, Other: Placebo1. Placebo (volume equivalent to 2.5 mg/kg UB-621) 2. 2.5 mg/kg UB-621 |
| Cohort 2 | Experimental | Biological: UB-621, Other: Placebo1. Placebo (volume equivalent to 5 mg/kg UB-621) 2. 5 mg/kg UB-621 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-621Monoclonal antibody by SC injection | Biological | Cohort 1, Cohort 2 |
| PlaceboThe 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. | Other | Cohort 1, Cohort 2 |
Primary outcome
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.
4 secondary outcomes
change of HSV-2 viral load
Time frame: 112 days
change of genital lesion rates
Time frame: 140 days
Clinical and Subclinical HSV-2 Shedding Rates
Time frame: 196 days
Rate of HSV-2 Shedding Episodes
Time frame: 196
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-621 in people with Genital Herpes, run by United BioPharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Lai (+886-3-668-4800, annie.lai@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of HSV-2 shedding rate. (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.