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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Genital Herpes
• Intervention / Treatment: Other: Placebo; Biological: UB-621 low-dose; Biological: UB-621 high-dose

• Study Type: Interventional
• Enrollment (Anticipated): 200
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; placebo matching UB-621	Other: Placebo; PBO- placebo matching to UB-621
Experimental: UB-621 low-dose; low-dose of UB-621	Biological: UB-621 low-dose; fully human anti-HSV mAb
Experimental: UB-621 high-dose; high-dose of UB-621	Biological: UB-621 high-dose; fully human anti-HSV mAb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first recurrence	Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	26 weeks
Lesion rate	Lesion rate is calculated as the number of days with lesion divided by the number of study days.	26 weeks
Duration of recurrent lesions	Duration of recurrent lesions is calculated as consecutive days with lesions.	26 weeks
Recurrence rate	Recurrence rate is defined as number of recurrences divided by the total number of study days.	26 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.	12 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.	12 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.	12 weeks
HSV-2 viral load	Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 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-A229-HSV

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