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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

Primary Purpose

Recurrent Genital Herpes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UB-621
Sponsored by
UBP Greater China (Shanghai) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Genital Herpes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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.
  • 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.

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.
  • 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
  • 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:

    1. albumin<3 g/dl
    2. ALP>2.5*ULN
    3. ALT>2.5*ULN
    4. AST>2.5*ULN
    5. Bilirubin>1.5*ULN
    6. CPK>1.5*ULN
    7. rGGT>2.5*ULN
    8. Hemoglobin: female<11 g/dl; male<12.5 g/dl
    9. platelet<125*10E3/ul
    10. WBC<2.5*10E3/ul or
    11. ANC<1.5*10E3/ul

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    cohort 1

    cohort 2

    Arm Description

    2.5 mg/kg UB-621 group

    5 mg/kg UB-621 group

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Lesion rate
    Lesion rate is calculated as the number of days with lesion divided by the number of study days.
    Duration of recurrent lesions
    Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
    Recurrence rate
    Recurrence rate is defined as number of recurrences divided by the total number of study days.
    Time to first recurrence of lesion
    Time to first recurrence of lesion as reported by patient and verified by investigator.

    Full Information

    First Posted
    January 15, 2021
    Last Updated
    May 16, 2022
    Sponsor
    UBP Greater China (Shanghai) Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04714060
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    January 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UBP Greater China (Shanghai) Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Genital Herpes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    cohort 1
    Arm Type
    Experimental
    Arm Description
    2.5 mg/kg UB-621 group
    Arm Title
    cohort 2
    Arm Type
    Experimental
    Arm Description
    5 mg/kg UB-621 group
    Intervention Type
    Biological
    Intervention Name(s)
    UB-621
    Intervention Description
    mAb by SC administration
    Primary Outcome Measure Information:
    Title
    Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
    Description
    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.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Lesion rate
    Description
    Lesion rate is calculated as the number of days with lesion divided by the number of study days.
    Time Frame
    16 weeks
    Title
    Duration of recurrent lesions
    Description
    Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
    Time Frame
    16 weeks
    Title
    Recurrence rate
    Description
    Recurrence rate is defined as number of recurrences divided by the total number of study days.
    Time Frame
    16 weeks
    Title
    Time to first recurrence of lesion
    Description
    Time to first recurrence of lesion as reported by patient and verified by investigator.
    Time Frame
    16 weeks
    Other Pre-specified Outcome Measures:
    Title
    HSV-2 shedding rate.
    Description
    Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.
    Time Frame
    8 weeks
    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 follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.
    Time Frame
    8 weeks
    Title
    Rate of HSV-2 Shedding Episodes
    Description
    The rate of HSV-2 shedding episodes is 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.
    Time Frame
    8 weeks
    Title
    HSV-2 viral load
    Description
    Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 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. 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. 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. 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Linda Shih, DVM
    Phone
    +886 36684800
    Ext
    3851
    Email
    linda.shih@unitedbiopharma.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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