Recurrent Genital HerpesPhase 2NCT04979975
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
A Phase 2 study testing UB-621 low-dose and UB-621 high-dose in people with Recurrent Genital Herpes, run by UBP Greater China (Shanghai) Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Genital Herpes
- What is being tested?
- UB-621 low-dose and UB-621 high-dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Conditions
- Recurrent Genital Herpes
- Being tested
- Placebo, UB-621 low-dose, UB-621 high-dose
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
PBO- placebo matching to UB-621
UB-621 low-doseBiological
fully human anti-HSV mAb
UB-621 high-doseBiological
fully human anti-HSV mAb
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | placebo matching UB-621 Receives: Other: Placebo |
| UB-621 low-dose | Experimental | low-dose of UB-621 Receives: Biological: UB-621 low-dose |
| UB-621 high-dose | Experimental | high-dose of UB-621 Receives: Biological: UB-621 high-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrence
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
Measured: 26 weeks
Secondary outcomes (4)
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.
Measured: 26 weeks
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Measured: 26 weeks
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions.
Measured: 26 weeks
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBP Greater China (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979975
- Sponsor's protocol ID
- UBP-A229-HSV
- Status last verified
- Sep 2022
- First submitted
- 19 Jul 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- 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 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
- ClinicalTrials.gov ID
- NCT04979975
- Acronym / sponsor ID
- UBP-A229-HSV
- Conditions
- Recurrent Genital Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UBP Greater China (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2021 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: Placeboplacebo matching UB-621 |
| UB-621 low-dose | Experimental | Biological: UB-621 low-doselow-dose of UB-621 |
| UB-621 high-dose | Experimental | Biological: UB-621 high-dosehigh-dose of UB-621 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| PlaceboPBO- placebo matching to UB-621 | Other | Placebo |
| UB-621 low-dosefully human anti-HSV mAb | Biological | UB-621 low-dose |
| UB-621 high-dosefully human anti-HSV mAb | Biological | UB-621 high-dose |
Primary outcome
Time to first recurrence
Time frame: 26 weeks
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
4 secondary outcomes
Proportion of subjects with episodes
Time frame: 26 weeks
Lesion rate
Time frame: 26 weeks
Duration of recurrent lesions
Time frame: 26 weeks
Recurrence rate
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Related trials for Recurrent Genital Herpes
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Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-621 low-dose and UB-621 high-dose in people with Recurrent Genital Herpes, run by UBP Greater China (Shanghai) Co., Ltd.
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 9 inclusion and 14 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: opening soon, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Shih, DVM (+886 36684800 ext. 3851, linda.shih@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence (time frame: 26 weeks). 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.