ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients

NCT03334240 | Terminated Phase 2 FDA Drug

• 1 other identifier: CLS003-CO-PR-003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to explore and evaluate the pharmacodynamics and clinical efficacy of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions

Conditions

HPV-Induced Genital Lesions

Keywords

HPV; Digoxin; Furosemide; Vulvar HSIL

Outcome Measures

Primary Outcomes (14)

• Lesion (vulvar HSIL or wart) size reduction

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Change in patient-reported outcomes

  Through study completion, up to 20 weeks

• HPV viral load assessment

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Change in the HPV viral load

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Mean HPV viral load

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Histology (regression of vulvar HSIL or AGWs to no dysplasia, HPV genotyping)

  Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)

• Local immunity status

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Percentage clearance of vulvar HSIL lesions

  For vulvar HSIL cohort

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Proportion of patients with all vulvar HSIL lesions cleared

  For vulvar HSIL cohort

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Histology (regression of vulvar HSIL to no dysplasia)

  For vulvar HSIL cohort

  Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)

• Histological recurrence in the Part 1 follow-up period

  For vulvar HSIL cohort

  Day 84, 126

• Percentage clearance of genital warts

  For genital wart cohort

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Proportion of patients with all genital warts cleared

  For genital wart cohort

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)

• Clinical recurrence in the Part 1 follow-up period

  For genital wart cohort

  Day 84, 126

Secondary Outcomes (1)

• Adverse event collection to assess safety/tolerability of CLS003

  Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study), and as volunteered by patient

Study Arms (2)

CLS003

EXPERIMENTAL

Digoxin and Furosemide topical formulation

Drug: CLS003

Vehicle

PLACEBO COMPARATOR

Inactive vehicle

Drug: Vehicle

Interventions

CLS003 DRUG

CLS003

CLS003

Vehicle DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years in general, stable good health (with the exception of the immunocompromised disorder) as per judgment of the investigator based upon the results of a medical history, physical examination, ECG, chemistry, hematology.
• In case of immunocompromised patients including but not limited to; patients receiving immunosuppressive therapy for any reason, patients with auto-immune disease, HIV patients, transplantation patients
• In case of genital warts patient group(s): have at least 3 genital warts (only applicable to Study Part 1)
• In case of vulvar HSIL: at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥ 20 mm OR in 2 perpendicular dimensions that when multiplied together give a surface area ≥ 120 mm² (only applicable to Study Part 1)
• If female of childbearing potential, have a negative urine pregnancy test at Screening and Day 0, and is willing to use effective contraception during the study and 3 months afterwards (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy)
• Able to participate and willing to give written informed consent and to comply with the study restrictions
• Ability to communicate well with the investigator in the Dutch language
• Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study

You may not qualify if:

• Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease
• Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
• Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
• Have any current relevant skin infections in the treatment area other than genital warts (inclusively, but not limited to atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
• Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
• Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
• Loss or donation of blood over 500 mL within three months prior to screening.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

LUMC/Centre For Human Drug Research

Leiden, Netherlands

Location

Study Officials

• J. (Koos) Burggraaf, MD, PhD

  Centre For Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 48 subjects are planned to be enrolled within one of the following three groups: a.) Immunocompetent patients with anogenital warts, b.) Immunocompromised with anogenital warts and c.) Immunocompromised with vulvar HSIL \[3:1, active/vehicle\]. Eligible subjects may enroll in an (up to) 8-week open-label Part 2 of study

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: October 5, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

NL (1)