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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04714060
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
UBP Greater China (Shanghai) Co., Ltd

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

Condition or disease Intervention/treatment Phase
Recurrent Genital Herpes Biological: UB-621 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: cohort 1
2.5 mg/kg UB-621 group
Biological: UB-621
mAb by SC administration

Experimental: cohort 2
5 mg/kg UB-621 group
Biological: UB-621
mAb by SC administration

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Lesion rate [ Time Frame: 16 weeks ]
    Lesion rate is calculated as the number of days with lesion divided by the number of study days.

  2. Duration of recurrent lesions [ Time Frame: 16 weeks ]
    Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.

  3. Recurrence rate [ Time Frame: 16 weeks ]
    Recurrence rate is defined as number of recurrences divided by the total number of study days.

  4. Time to first recurrence of lesion [ Time Frame: 16 weeks ]
    Time to first recurrence of lesion as reported by patient and verified by investigator.

Other Outcome Measures:
  1. HSV-2 shedding rate. [ Time Frame: 8 weeks ]
    Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.

  2. Clinical and Subclinical HSV-2 Shedding Rates [ Time Frame: 8 weeks ]
    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.

  3. Rate of HSV-2 Shedding Episodes [ Time Frame: 8 weeks ]
    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.

  4. HSV-2 viral load [ Time Frame: 8 weeks ]
    Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714060

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Contact: Linda Shih, DVM +886 36684800 ext 3851 linda.shih@unitedbiopharma.com

Sponsors and Collaborators
UBP Greater China (Shanghai) Co., Ltd
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Responsible Party: UBP Greater China (Shanghai) Co., Ltd
ClinicalTrials.gov Identifier: NCT04714060    
Other Study ID Numbers: UBP-A228-HSV
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Genitalis
Herpes Simplex
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases