A Phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions

Phase 1

• Conditions: Patients with cervical histologic HSIL.; MedDRA version: 21.0Level: LLTClassification code 10064455Term: HSILSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-001342-19-DE
• Lead Sponsor: Asieris MediTech Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 384

Inclusion Criteria

1.Biopsy-confirmed HSIL histology determined by a panel of three
pathologists from at the central laboratory in of each region (China, US, and Europe),biopsy tests performed before the signing of the informed consent form and within 2 months prior to administration are acceptable, no repeated test is required;
2. Adequate colposcopy including:
a. visualization of entire cervical transformation zone including the squamocolumnar junction
b. visualization of entire lesion margin
3. Colposcopically visible lesion after biopsy, before treatment (Note: To ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy)
4. Average sized uterine cervix suitable for application of the Cevira® device
5. Female (not breastfeeding, with negative pregnancy test and using either a highly effective method of contraception during the entire study and 30 days after end of the study or being post-menopausal for at least 1 year or sterilized women)
6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
7. Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

1. Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of
the uterine cervix area
2. Invasive cervical cancer
3. Adenocarcinoma in situ, or other glandular intraepithelial lesions
4. Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform
endocervical curettage [ECC] test at the discretion of the investigators)
5. Lesion(s) extending to the vaginal vault
6. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological
infection as per colposcopy and clinical examination
7. Vaginal bleeding at time of treatment at the discretion of the investigator
8. Pregnancy
9. Nursing
10. Childbirth or miscarriage within six weeks of enrolment
11. Previous treatment of cervical intraepithelial lesions (CIN) or cervical invasive disease
12. History of toxic shock syndrome
13. Known or suspected porphyria
14. Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or
aminolevulinic acid)
15. Known allergy to silicone
16. Use of heart pacemaker
17. Use of any mechanical barriers such as the contraceptive FemCap
18. Inappropriate anatomical and physiological conditions (natural or acquired through disease) such as metrorrhagia, uterine/cervical prolapse, vaginal dryness, period of the woman's menstruation and other. If, the therapeutic drugs for concomitant diseases have the effect of treating HPV, HSIL and tumours, as well as regulating immunologic function, which will affect the efficacy evaluation of Cevira®
19. Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days or five half-lives of the drug, whichever is longer, prior to enrolment.
20. Patients that in the investigator’s opinion are not suitable for participation
21. Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients<br>with cervical histologic HSIL.;Secondary Objective: Not applicable;Primary end point(s): The proportion of responders at 6 months after first treatment;<br>A responder is defined as follows:<br>• Normal histology;<br>or<br>• LSIL histology and clearance of baseline HPV <br>;Timepoint(s) of evaluation of this end point: 6 months after first treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first<br>treatment.<br>The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.<br>The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months<br>after first treatment.<br>The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months<br>after first treatment. <br>;Timepoint(s) of evaluation of this end point: At 6 months after first treatment.