Clinical Trials/NCT06450990

NCT06450990

Not Yet Recruiting

Phase 1

Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study

NEXBIOME THERAPEUTICS0 sites165 target enrollmentJuly 8, 2024

ConditionsBacterial Vaginosis Vulvovaginal Candidiasis

InterventionsBGY-1601-VT PLACEBO

DrugsBGY-1601-VT

Overview

Phase: Phase 1
Intervention: BGY-1601-VT
Conditions: Bacterial Vaginosis
Sponsor: NEXBIOME THERAPEUTICS
Enrollment: 165
Primary Endpoint: To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis

Registry

clinicaltrials.gov

Start Date

July 8, 2024

End Date

February 26, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

NEXBIOME THERAPEUTICS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Post-menarche woman aged 18 to 50 years old (inclusive),
•With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection
•No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,
•Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,

Exclusion Criteria

•Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month
•Current herpes simplex flare-up in the genital area,
•Vulvar condyloma due to the human papilloma virus;
•Vulvar dermatoses (e.g.: psoriasis or lichenification);
•Clinical diagnosis of BV or VVC within 4 months;
•Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;
•Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;
•Participant using any intravaginal product (local contraceptive \[spermicide, hormonal ring\], moisturizer, tampon, intimate hygiene product, etc.);
•Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
•Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;

Arms & Interventions

BGY-1601-VT #1

Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)

Intervention: BGY-1601-VT

BGY-1601-VT #1

Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)

Intervention: PLACEBO

BGY-1601-VT #2

BGY-1601#2: one verum tablet at D0 and one verum tablet at D2

Intervention: BGY-1601-VT

PLACEBO

Placebo: one placebo tablet at D0 and one placebo tablet at D2

Intervention: PLACEBO

Outcomes

Primary Outcomes

To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection

Time Frame: Visit 2 (V2) = 7 days

Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy

Secondary Outcomes

To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo, dosing regimen #2 versus placebo, and dosing regimen #1 versus dosing regimen #2, to treat acute vaginal infection(Visit 2 (7 days) and Visit 3 (28 days))
To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and(V2 (7 days) and V3 (28 days))
To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.(Visit 2 (7 days) and Visit 3 (28 days))