A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621

NCT03595995 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: UBP-A206-HSV
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• change of HSV-2 shedding rate.

  The primary endpoint for this study is to evaluate the reduction in HSV-2 shedding rate within subjects in the Baseline Period versus Follow-up Period.

  112 days

Secondary Outcomes (4)

• change of HSV-2 viral load

  112 days

• change of genital lesion rates

  140 days

• Clinical and Subclinical HSV-2 Shedding Rates

  196 days

• Rate of HSV-2 Shedding Episodes

  196

Study Arms (2)

Cohort 1

EXPERIMENTAL

1. Placebo (volume equivalent to 2.5 mg/kg UB-621) 2. 2.5 mg/kg UB-621

Biological: UB-621; Other: Placebo

Cohort 2

EXPERIMENTAL

1. Placebo (volume equivalent to 5 mg/kg UB-621) 2. 5 mg/kg UB-621

Biological: UB-621; Other: Placebo

Interventions

UB-621 BIOLOGICAL

Monoclonal antibody by SC injection

Cohort 1; Cohort 2

Placebo OTHER

The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week 16.
• 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 prior to and upon the administration of study drug.
• Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.

You may not qualify if:

• 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.
• Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
• 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

Sponsors & Collaborators

• United BioPharma: lead

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Central Study Contacts

Annie Lai

CONTACT

+886-3-668-4800; annie.lai@unitedbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 23, 2018
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 3, 2022

Record last verified: 2022-09