A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin (Candida albicans Skin Test Antigen for Cellular Hypersensitivity) for the Treatment of Common Warts (Verruca vulgaris) in Adolescents and Adults (CFW-3A)

JRCT ID: jRCT2031230342

Registered date:12/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Common Warts (Verruca vulgaris)
• Date of first enrollment: 05/03/2024
• Target sample size: 330
• Countries of recruitment: United States,Japan
• Study type: Interventional
• Intervention(s): Subjects randomized to Candin or placebo will receive a fixed 0.5 mL injection at each dose. Subjects will receive up to 10 total doses (of Candin or placebo), with subjects receiving injections every 2 weeks (14 +/- 2 days) at the region of the interdigitated base of the wart (epidermal-dermal junction) for up to 10 injections total per subject or until clinical clearance of the treatment wart, whichever occurs first. If clinical clearance of the treatment wart occurs before or on the 10th injection visit, the site of the previously existing treatment wart will receive a final injection at the visit when clearance is recorded. Subjects with clinical clearance will then enter the 12-week Observational Period.

Outcome(s)

• Primary Outcome: The primary efficacy endpoint is the percentage of subjects who achieve complete resolution of the treatment wart without recurrence for 12 weeks after the last injection.

Secondary Outcome

1. Time from first injection to achieving clinical clearance of the treatment wart.
2. Proportion of subjects with clinical clearance of at least 50% of all measured warts at Follow-up Visit #2.
3. Proportion of subjects with clinical clearance of all measured warts at Follow-up Visit #2.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Subjects 12 years of age and older at the time of signing the ICF.
2. Otherwise healthy (no ongoing medical condition that would prohibit enrollment in this study per the opinion of the Principal Investigator) with at least 3, but no more than 20, common warts (Verruca vulgaris). Per the opinion of the investigator, one of which (i.e., the treatment wart) is suitable for regular study drug injections (i.e., must be located on the hands (excluding palms), feet (including toes) (excluding the soles of the feet), limbs, and/or trunk) and at least two of which are suitable for selection as measured wartts. All other warts (flat, palmar, plantar, facial, periungual, genital, or warts in the region of a pre-existing inflammatory condition) are excluded from being injected or measured but will be photographed (with the exception of genital warts) and assessed as either "present" or "absent."
3. For adults, mentally and legally capable of giving informed consent prior to any study-related procedures. For adolescents, parent and adolescent are mentally and legally capable of giving informed consent/assent prior to any study-related procedures.
4. Female subjects (assigned female at birth) are eligible to participate in the study if they are not pregnant or breastfeeding, if they do not intend to get pregnant during the study, and if they agree to comply with the contraception and reproduction restrictions of the study as follows:
a. Female subjects of childbearing potential (have experienced menstrual bleeding within the last year and are not surgically or otherwise sterile) must be using a method of contraception that is "highly effective" (i.e., < 1% failure rate) for at least 30 days prior to the first injection (Screening Visit) and at least 90 days following the last injection;
b. Highly effective forms of birth control used by females include abstinence, hormonal contraceptives (oral, patch, injectable or vaginal ring), and implantable device (implantable rod or intrauterine device). If taking hormonal contraceptives, subjects must be on a stable dose since at least 30 days before the first injection (Screening Visit).
c. Postmenopausal subjects must be at least 55 years of age and have had no menstrual bleeding for at least 1 year before initial injection at the Screening Visit
d. Female subjects of childbearing potential must have evidence of a negative urine pregnancy test result at the Baseline Visit.
5. All male subjects (assigned male at birth), from the day of initial injection until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male subjects with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) (For Japan, male subjects with partners of childbearing potential must be willing to use one effective method of birth control such as condom etc.) to prevent pregnancy and drug exposure of a partner, and must refrain from donating sperm for fathering a child for 90 days following the last injection.

Exclude criteria

1. Presence of systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function, in the opinion of the investigator.
2. Candin delayed type hypersensitivity (DTH) reaction test delayed wheal sized < 5 mm or > 25 mm at the Baseline Visit.
3. History of keloid formation.
4. Treatment with immunotherapy (e.g., diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study.
5. Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study.
6. Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half-lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids (topical or inhaled steroids are acceptable)).
7. Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study.

Related Information

• Primary Sponsor: Kanmuri Kazuhiro
• Secondary ID(s): NCT05889845