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

Recurrent Genital Herpes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04979975
• Other study ID #: UBP-A229-HSV
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: December 2026

Study information

• Verified date: September 2022
• Source: UBP Greater China (Shanghai) Co., Ltd
• Contact: Linda Shih, DVM
• Phone: +886 36684800
• Email: linda.shih[@]unitedbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Herpes Genitalis
• Recurrence
• Recurrent Genital Herpes

Intervention

Other:
• Placebo
PBO- placebo matching to UB-621

Biological:
• UB-621 low-dose
fully human anti-HSV mAb
• UB-621 high-dose
fully human anti-HSV mAb

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UBP Greater China (Shanghai) Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HSV-2 shedding rate	Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.	12 weeks
Other	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
Other	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
Other	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
Primary	Time to first recurrence	Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.	26 weeks
Secondary	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
Secondary	Lesion rate	Lesion rate is calculated as the number of days with lesion divided by the number of study days.	26 weeks
Secondary	Duration of recurrent lesions	Duration of recurrent lesions is calculated as consecutive days with lesions.	26 weeks
Secondary	Recurrence rate	Recurrence rate is defined as number of recurrences divided by the total number of study days.	26 weeks