Efficacy, safety, and dose-response of a Live Biotherapeutic Product (BGY-1601-VT, vaginal tablet) as a first-line monotherapy in women with acute vaginal infection: a randomized, double-blind, placebo-controlled study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nexbiome Therapeutics

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

16 Oct 2024 → 20 Feb 2026

Decision date (initial)

2024-06-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Nexbiome therapeutics

External identifiers

EU CT number

2023-508958-26-00

ClinicalTrials.gov

NCT06450990

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Efficacy, Safety

The main objective is to compare the efficacy of BGY-1601-VT, according to the dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection :
- 7 days (-1/+3) after treatment start (V2)
- In women with confirmed diagnosis of Bacterial Vaginosis (BV), Vulvovaginal Candidiadis (VVC), or mixed infection (BV+VCC).

Secondary objectives 3

1. 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.
2. To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimen #2, and the safety of placebo.
3. To compare the evolution of Lacticaseibacillus rhamnosus Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.

Conditions and MedDRA coding

Gynaecological

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. I1. Post-menarche / premenopausal women aged 18 to 50 years old (inclusive)
2. I2. With suspected BV and/or VVC, presenting at least two of the following symptoms of acute vaginal infection: Fluid abundant discharge, thick abundant discharge, fishy odor, external (vulvar) or internal (vaginal) itching, external (vulvar) or internal (vaginal) burning.
3. I3. Women not at risk of pregnancy.
4. I4. Negative pregnancy urinary test performed during the screening visit.
5. I5. Good general and mental health in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
6. I6. Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form.
7. I7. Affiliated with a health insurance through a public or private health insurance provider.

Exclusion criteria 17

1. E1. Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month.
2. E9. Participant who had a sexual intercourse from 48h prior to D0, or who is planning to have a sexual intercourse from V1 to V2, or within 48h prior to V3.
3. E10. Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
4. E11. Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months.
5. E12. Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause.
6. E13. With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient.
7. E14. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
8. E15. Under legal protection (guardianship, wardship) or deprived from her rights following administrative or judicial decision.
9. E16. Presenting a psychological or linguistic incapability to sign the informed consent.
10. E17. Impossible to contact in case of emergency.
11. E2. Current herpes simplex flare-up in the genital area.
12. E3. Vulvar condyloma due to the human papilloma virus.
13. E4. Vulvar dermatoses (e.g.: psoriasis or lichenification).
14. E5. Clinical diagnosis of BV or VVC within 4 months.
15. E6. Treatment received (local or systemic) with any antibiotic, antifungal, antiseptic or probiotic therapy (etc.) within 7 days prior to screening or within 5 known half-lives of the drug (whichever is longer), regardless of the indication
16. E7. Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.).
17. E8. Participant who is likely to be menstruating between D0 and D4.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.

Secondary endpoints 11

1. Percentage of participants with clinical cure at the time point AND no rescue therapy started.
2. Percentage of participants with improved symptoms at the time point, related to D0 (self-assessment): PGI-C scale ≤ 2 AND no rescue therapy started.
3. Percentage of participants with improved symptoms at the time point, related to D0 (as per the investigator’s assessment): CGI-C scale ≤ 2 AND no rescue therapy started.
4. Percentage of participants who started a rescue therapy before the time point.
5. Evolution of each symptom from D0 to the time point, as per the participant’s assessment (resolution / improvement / no change / worsening): Itching / pruritus, burning / irritation, pain, leucorrhea / vaginal discharge.
6. Evolution of each symptom from D0 to the time point, as per the investigator’s assessment (resolution / improvement / no change / worsening): Leucorrhoea / vaginal discharge, edema, erythema, ulceration, pH.
7. Time to resolution of all symptoms present at D0, as reported in the participant’s diary.
8. Time to symptom recurrence after resolution, if applicable, as reported in the participant’s diary.
9. Time to rescue therapy.
10. Number of events / participants with adverse events (Aes), depending on their classification (systemic / local; severe; treatment-emergent).
11. Quantification of Lcr35 in the vaginal microbiota, from quantitative polymerase chain reaction (qPCR) on vaginal secretions at the time point.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nexbiome Therapeutics

Sponsor organisation

Nexbiome Therapeutics

Address

22 Allee Alan Turing

City

Clermont Ferrand

Postcode

63000

Country

France

Scientific contact point

Organisation

Nexbiome Therapeutics

Contact name

Véronique Trochon-Joseph

Public contact point

Organisation

Nexbiome Therapeutics

Contact name

Cyrille Jeune

Third parties 1

Locations

2 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications