臨床研究等提出・公開システム

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)

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)

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

Clinical Trials Information -

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

Oct. 26, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 Investigator).
3. At least 3, but no more than 20, common warts (Verruca vulgaris) per the opinion of the Investigator, at least 2 of which are suitable for selection as measured warts. Lesions that could potentially be non warts should not be included in the common wart count. If there is any uncertainty about the classification of certain lesions, the Medical Monitor should be contacted before the subject is enrolled.
4. At least 1 of the common warts is located on the hands (excluding palms and palmar aspect of fingers), feet (excluding soles and plantar aspect of toes), limbs, and/or trunk, which is suitable for selection as the treatment wart.
5. 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.
6. 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 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 or deemed postmenopausal by the Investigator (provided the subject has not experienced menstrual bleeding in the past year).
d.Female subjects of childbearing potential must have evidence of a negative urine pregnancy test result at the Baseline Visit.
7. 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.

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, coix seed extract, or any other treatments for warts (including over-the-counter products) within the 30 days prior to the Baseline Visit or during the study.

Both

Common Warts (Verruca vulgaris)

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.

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.

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.

Oct. 04, 2023

Oct. 04, 2023

Oct. 04, 2023

Oct. 04, 2023

No

United States