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Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL) (APRICITY)

Primary Purpose

Cervical Intraepithelial Neoplasia Grade 2/3

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cevira®
Placebo
Sponsored by
Asieris MediTech (Hong Kong) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia Grade 2/3

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe);

  2. Adequate colposcopy including:

    1. visualization of entire cervical transformation zone including the squamocolumnar junction
    2. 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. Use of adequate birth control until completion of the 6 month assessment visit
  6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
  7. Signed written informed consent

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. Patients who previously received surgical treatment, have incomplete cervical structure and have recurrent HSIL; or patients who received other treatment after the confirmed diagnosis of HSIL
  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. Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days
  18. Patients that in the investigator's opinion are not suitable for participation
  19. Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cevira® treatment

Placebo ointment

Arm Description

The Cevira® treatment is an integrated combination of drug and device

The placebo ointment contains only vehicle, and is similar in appearance and consistence as the Cevira® ointment. The placebo device is identical in appearance as the Cevira® device, but does not provide light.

Outcomes

Primary Outcome Measures

The proportion of responders at 6 months after first treatment
A responder is defined as follows: Normal histology; or LSIL histology and clearance of baseline HPV

Secondary Outcome Measures

The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.

Full Information

First Posted
July 20, 2020
Last Updated
August 11, 2022
Sponsor
Asieris MediTech (Hong Kong) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04484415
Brief Title
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
Acronym
APRICITY
Official Title
A Double Blind, Prospective, Randomized, Placebo Controlled, Multi-center Phase 3 Study to Evaluate Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asieris MediTech (Hong Kong) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL).
Detailed Description
To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.A total of 384 subjects will be enrolled globally, among which, 300 subjects of them will be enrolled in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 2/3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cevira® treatment
Arm Type
Experimental
Arm Description
The Cevira® treatment is an integrated combination of drug and device
Arm Title
Placebo ointment
Arm Type
Placebo Comparator
Arm Description
The placebo ointment contains only vehicle, and is similar in appearance and consistence as the Cevira® ointment. The placebo device is identical in appearance as the Cevira® device, but does not provide light.
Intervention Type
Combination Product
Intervention Name(s)
Cevira®
Intervention Description
The device is a single-use, disposable, LED-based red light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
The placebo device is identical in appearance as the Cevira® device, but does not provide light.
Primary Outcome Measure Information:
Title
The proportion of responders at 6 months after first treatment
Description
A responder is defined as follows: Normal histology; or LSIL histology and clearance of baseline HPV
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
Description
The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
Time Frame
6 months
Title
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
Description
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
Time Frame
6 months
Title
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
Description
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
Time Frame
6 months
Title
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
Description
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe); Adequate colposcopy including: visualization of entire cervical transformation zone including the squamocolumnar junction visualization of entire lesion margin 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) Average sized uterine cervix suitable for application of the Cevira® device Use of adequate birth control until completion of the 6 month assessment visit Age 18 or older (Note: Patients aged 18-20 should not be actively recruited) Signed written informed consent Exclusion Criteria: Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area Invasive cervical cancer Adenocarcinoma in situ, or other glandular intraepithelial lesions Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage [ECC] test at the discretion of the investigators) Lesion(s) extending to the vaginal vault Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination Vaginal bleeding at time of treatment at the discretion of the investigator Pregnancy Nursing Childbirth or miscarriage within six weeks of enrolment Patients who previously received surgical treatment, have incomplete cervical structure and have recurrent HSIL; or patients who received other treatment after the confirmed diagnosis of HSIL History of toxic shock syndrome Known or suspected porphyria Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid) Known allergy to silicone Use of heart pacemaker Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days Patients that in the investigator's opinion are not suitable for participation Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinghe Lang, MD,PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Zhuang, PhD
Organizational Affiliation
Asieris MediTech (Hong Kong) Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35667715
Citation
Chen F, Novak Z, Dannecker C, Mokras C, Sui L, Zhang Y, You Z, Han L, Lang J, Hillemanns P. Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol. BMJ Open. 2022 Jun 6;12(6):e061740. doi: 10.1136/bmjopen-2022-061740.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

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