Recurrent Genital HerpesPhase 2NCT04714060
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
A Phase 2 study testing UB-621 in people with Recurrent Genital Herpes, run by UBP Greater China (Shanghai) Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Genital Herpes
- What is being tested?
- UB-621
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Jan 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- 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 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.
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- 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.
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.
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Conditions
- Recurrent Genital Herpes
- Being tested
- UB-621
- 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
mAb by SC administration
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | 2.5 mg/kg UB-621 group Receives: Biological: UB-621 |
| cohort 2 | Experimental | 5 mg/kg UB-621 group Receives: Biological: UB-621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (4)
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Measured: 16 weeks
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
Measured: 16 weeks
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Measured: 16 weeks
Time to first recurrence of lesion
Time to first recurrence of lesion as reported by patient and verified by investigator.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Jan 2025 (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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 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
- NCT04714060
- Sponsor's protocol ID
- UBP-A228-HSV
- Status last verified
- May 2022
- First submitted
- 15 Jan 2021
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04714060
- Acronym / sponsor ID
- UBP-A228-HSV
- Conditions
- Recurrent Genital Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- UBP Greater China (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 19 Jan 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Biological: UB-6212.5 mg/kg UB-621 group |
| cohort 2 | Experimental | Biological: UB-6215 mg/kg UB-621 group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (21 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.
- 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)
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-621mAb by SC administration | Biological | cohort 1, cohort 2 |
Primary outcome
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
Time frame: 16 weeks
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.
4 secondary outcomes
Lesion rate
Time frame: 16 weeks
Duration of recurrent lesions
Time frame: 16 weeks
Recurrence rate
Time frame: 16 weeks
Time to first recurrence of lesion
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
Related trials for Recurrent Genital Herpes
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Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
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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
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Recurrent Genital Herpes
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 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 21 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 18 May 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 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?
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison) (time frame: 16 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 18 May 2022.