OM202JP Clinical Study of KNP2002

Phase 2

Active, not recruiting

• Conditions: Common Wart
• Interventions: Drug: KNP2002; Drug: Placebo of KNP2002

• Registration Number: NCT05896215
• Lead Sponsor: KinoPharma Inc.

Brief Summary

The goal of this clinical trial is to evaluate safety and efficacy of KNP2002 in patients with common warts aged 15 to 50 years old.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2023-06-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Subjects aged 15 to 49 years old
• Subjects with common warts on the upper or lower limb
• Subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration
• Subjects who have given their voluntary written consent to participate in this clinical trial

Exclusion Criteria

• Subjects with 5 or more warts on the upper or lower limbs
• Subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts
• Subjects with a history of allergy to topical skin preparations
• Subjects with a history of malignant tumor within 5 years before administration of study drug
• Subjects with any of the following diseases: Malignant tumor; Serious heart disease; Poorly controlled diabetes/hypertension
• Women who are pregnant, may become pregnant, or are breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose group	KNP2002	Topical administration of low dose of KPN2002
Placebo group	Placebo of KNP2002	Topical administration of placebo
Middle dose group	KNP2002	Topical administration of middle dose of KPN2002
High dose group	KNP2002	Topical administration of high dose of KPN2002

Primary Outcome Measures

Name	Time	Method
Change in wart area	At 16 weeks after starting administration	Percent change in wart area from baseline

Secondary Outcome Measures

Name	Time	Method
Wart improvement rate	At 4, 8, 12, and 16 weeks after starting administration	Wart improvement rate categorized by rate of change in wart area
Change in wart area over time	At 4, 8, 12, and 16 weeks after starting administration	Percent change in wart area from baseline
Wart disappearance rate	Up to 16 weeks after starting administration	Proportion of patients with warts disappearing

Trial Locations

Locations (15)

Igarashi Clinic; 🇯🇵 Kita-Ku, Tokyo, Japan

Maruyama Dermatology Clinic; 🇯🇵 Koto-Ku, Tokyo, Japan

Tsunoda Clinic; 🇯🇵 Arakawa-Ku, Tokyo, Japan

Kawaharamachi Dermatology; 🇯🇵 Maebashi, Gunma, Japan

Takashima Dermatology; 🇯🇵 Kobe, Hyogo, Japan

Nishino Dermatology Clinic; 🇯🇵 Kobe, Hyogo, Japan

Queen's Square, Dermatology, Allergy; 🇯🇵 Yokohama, Kanagawa, Japan

Sugisawa Dermatology Clinic; 🇯🇵 Katsushika-Ku, Tokyo, Japan

Okuda Dermatology Clinic; 🇯🇵 Setagaya-Ku, Tokyo, Japan

Hayami Dermatology; 🇯🇵 Osaka, Japan

Todoroki Dermatology Clinic; 🇯🇵 Nakano-Ku, Tokyo, Japan

Asai Dermatology Clinic; 🇯🇵 Yokohama, Kanagawa, Japan

Sugai Dermatology Parkside Clinic; 🇯🇵 Utsunomiya, Tochigi, Japan

Tetsuya Dermatology; 🇯🇵 Himeji, Hyogo, Japan

Okawa Dermatology Clinic; 🇯🇵 Sakai, Osaka, Japan