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 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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Genital Herpes
• Intervention / Treatment: Biological: UB-621

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Linda Shih, DVM; Phone Number: 3851 +886 36684800; Email: linda.shih@unitedbiopharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion rate	Lesion rate is calculated as the number of days with lesion divided by the number of study days.	16 weeks
Duration of recurrent lesions	Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.	16 weeks
Recurrence rate	Recurrence rate is defined as number of recurrences divided by the total number of study days.	16 weeks
Time to first recurrence of lesion	Time to first recurrence of lesion as reported by patient and verified by investigator.	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HSV-2 shedding rate.	Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.	8 weeks
Clinical and Subclinical HSV-2 Shedding Rates	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.	8 weeks
Rate of HSV-2 Shedding Episodes	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.	8 weeks
HSV-2 viral load	Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.	8 weeks

Collaborators and Investigators

• Sponsor: UBP Greater China (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Herpesviridae Infections; Herpes Simplex; Recurrence; Herpes Genitalis
• Other Study ID Numbers: UBP-A228-HSV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No