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Artesunate Vaginal Inserts for the Treatment of CIN2/3 (ART_CIN_II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098744
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Amarex Clinical Research
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
M.D. Anderson Cancer Center
The Cleveland Clinic
Information provided by (Responsible Party):
Frantz Viral Therapeutics, LLC

Brief Summary:

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.


Condition or disease Intervention/treatment Phase
CIN 2/3 HPV Infection Pre-Cancerous Dysplasia Cervical Dysplasia Drug: Artesunate vaginal insert Drug: Placebo vaginal insert Phase 2

Detailed Description:

Eligible participants in this study are randomized to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Participants are followed closely with colposcopies at weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is unblinded. Participants in the placebo group who still have CIN2/3 have the option to start treatment with artesunate within 4 weeks. Participants in the artesunate treatment who still have CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or cold knife conization) within 6 weeks.

Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

Secondary Objectives:

  • To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3
  • To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
  • To evaluate histopathologic regression after the week 15 time point

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Drug: Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Other Names:
  • Artesunic acid
  • DHA
  • artemisinin

Placebo Comparator: Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit.
Drug: Placebo vaginal insert
Placebo for artesunate vaginal inserts




Primary Outcome Measures :
  1. Proportion of subjects with histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15 [ Time Frame: 15 weeks ]
    Number of participants who have histologic regression of CIN2/3 to CIN1 within the study window (15 weeks)


Secondary Outcome Measures :
  1. Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15 [ Time Frame: 15 weeks ]
    Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks)


Other Outcome Measures:
  1. Number of participants with Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 28 weeks ]
    Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention

  2. Number of participants who withdrew from the study due to TEAEs [ Time Frame: 28 weeks ]
    Number of participants who were withdrawn from the study due to adverse events related to the study drug



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for women only as it is a treatment for cervical intraepithelial neoplasia (CIN2/3)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult females age ≥ 18 years
  • Capable of informed consent
  • Any HPV genotype detectable by DNA test/HPV genotyping
  • Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2, CIN3, or CIN2/3
  • Women of childbearing potential agree to use birth control through week 28 of the study.
  • Weight ≥ 50kg

Exclusion Criteria:

  • Pregnant and nursing women
  • Active autoimmune disease
  • Taking immunosuppressive medication
  • HIV seropositivity
  • Immunocompromised subjects
  • Evidence of concurrent cervical adenocarcinoma in situ
  • Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098744


Contacts
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Contact: Mihaela Plesa, BA 443-695-5243 mplesa@frantzgroup.com
Contact: Ahmad Bayat, MD (301) 956-2523 ahmadb@amarexcro.com

Locations
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United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21205
Contact: Cornelia Trimble, MD    410-502-0512    ctrimbl@jhmi.edu   
Contact: Maria Hom    410-502-0512    mhom3@jhmi.edu   
Principal Investigator: Cornelia L Trimble, MD         
United States, Texas
The Harris Health System
Houston, Texas, United States, 77026
Contact: Jessica Gallegos    713-563-4580    jrgalleg@mdanderson.org   
Contact: Cindy Melendez    713-563-4582    cvmelend@mdanderson.org   
Sponsors and Collaborators
Frantz Viral Therapeutics, LLC
Amarex Clinical Research
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
M.D. Anderson Cancer Center
The Cleveland Clinic
Investigators
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Principal Investigator: Cornelia L Trimble, MD Johns Hopkins University
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Responsible Party: Frantz Viral Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04098744    
Other Study ID Numbers: J1991
IRB00219993 ( Other Identifier: JHM IRB )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frantz Viral Therapeutics, LLC:
treatment study
cancer prevention
non-surgical
HPV disease
CIN
topical treatment
vaginal inserts
artesunate
artemisinin
non-invasive
high risk HPV
Additional relevant MeSH terms:
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Papillomavirus Infections
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Artesunate
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics