search
Back to results

Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes

Primary Purpose

Recurrent Genital Herpes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
UB-621 low-dose
UB-621 high-dose
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≧18 years at the time of signing ICF
  2. HSV-2 seropositive when screening
  3. A history of recurrent genital herpes and experience 6-12 episodes in the past year
  4. Negative result of the HIV assay
  5. In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions
  6. Keep daily diary during the study period
  7. Female subjects: negative serum β-HCG at screening and no beast-feeding.
  8. Use contraception during study participation
  9. Understanding and willing to fully comply with study interventions and restrictions.

Exclusion Criteria:

  1. 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).
  2. History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases.
  3. Use of systemic steroids or immunomodulators within 30 days prior to the screening
  4. Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer.
  5. Vaccination within 30 days prior to the screening.
  6. Prior exposure to any HSV vaccines
  7. Known hypersensitive to monoclonal antibodies
  8. ECG abnormalities with clinical relevance or cardiovascular diseases at screening
  9. Serum creatinine > 1.5 mg/dL at screening
  10. AST and ALT > 2.5 x ULN at screening
  11. HBsAg positive or HCT antibody positive at screening
  12. Syphilis RPR test positive at screening
  13. TB history or documented T-spot positive, or now is under treatment of TB
  14. Any other circumstances that are determined to affect the conduct or successful completion of the clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    UB-621 low-dose

    UB-621 high-dose

    Arm Description

    placebo matching UB-621

    low-dose of UB-621

    high-dose of UB-621

    Outcomes

    Primary Outcome Measures

    Time to first recurrence
    Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.

    Secondary Outcome Measures

    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.
    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.
    Recurrence rate
    Recurrence rate is defined as number of recurrences divided by the total number of study days.

    Full Information

    First Posted
    July 19, 2021
    Last Updated
    September 29, 2022
    Sponsor
    UBP Greater China (Shanghai) Co., Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04979975
    Brief Title
    Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (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
    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

    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
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    placebo matching UB-621
    Arm Title
    UB-621 low-dose
    Arm Type
    Experimental
    Arm Description
    low-dose of UB-621
    Arm Title
    UB-621 high-dose
    Arm Type
    Experimental
    Arm Description
    high-dose of UB-621
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    PBO- placebo matching to UB-621
    Intervention Type
    Biological
    Intervention Name(s)
    UB-621 low-dose
    Intervention Description
    fully human anti-HSV mAb
    Intervention Type
    Biological
    Intervention Name(s)
    UB-621 high-dose
    Intervention Description
    fully human anti-HSV mAb
    Primary Outcome Measure Information:
    Title
    Time to first recurrence
    Description
    Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects with episodes
    Description
    Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects.
    Time Frame
    26 weeks
    Title
    Lesion rate
    Description
    Lesion rate is calculated as the number of days with lesion divided by the number of study days.
    Time Frame
    26 weeks
    Title
    Duration of recurrent lesions
    Description
    Duration of recurrent lesions is calculated as consecutive days with lesions.
    Time Frame
    26 weeks
    Title
    Recurrence rate
    Description
    Recurrence rate is defined as number of recurrences divided by the total number of study days.
    Time Frame
    26 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
    12 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
    12 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
    12 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
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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. Exclusion Criteria: 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 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
    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

    Learn more about this trial

    Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes

    We'll reach out to this number within 24 hrs