OM202JP Clinical Study of KNP2002

A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Common Wart
• Intervention / Treatment: Drug: KNP2002; Drug: Placebo of KNP2002

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Katsuhiko Sato, Ph.D.; Phone Number: +81-3-6264-9604; Email: k.sato@kinopharma.com

Study Locations

• Japan
  • Osaka, Japan, 537-0013
    • Hayami Dermatology
  • Gunma
    • Maebashi, Gunma, Japan, 371-0046
      • Kawaharamachi Dermatology
  • Hyogo
    • Himeji, Hyogo, Japan, 672-8084
      • Tetsuya Dermatology
    • Kobe, Hyogo, Japan, 657-0027
      • Takashima Dermatology
    • Kobe, Hyogo, Japan, 657-0065
      • Nishino Dermatology Clinic
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 220-6208
      • Queen's Square, Dermatology, Allergy
    • Yokohama, Kanagawa, Japan, 240-0013
      • Asai Dermatology Clinic
  • Osaka
    • Sakai, Osaka, Japan, 593-8301
      • Okawa Dermatology Clinic
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 321-2471
      • Sugai Dermatology Parkside Clinic
  • Tokyo
    • Arakawa-Ku, Tokyo, Japan, 116-0003
      • Tsunoda Clinic
    • Katsushika-Ku, Tokyo, Japan, 125-0041
      • Sugisawa Dermatology Clinic
    • Kita-Ku, Tokyo, Japan, 115-0045
      • Igarashi Clinic
    • Koto-Ku, Tokyo, Japan, 136-0074
      • Maruyama Dermatology Clinic
    • Nakano-Ku, Tokyo, Japan, 164-0001
      • Todoroki Dermatology Clinic
    • Setagaya-Ku, Tokyo, Japan, 157-0062
      • Okuda Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group; Topical administration of low dose of KPN2002	Drug: KNP2002; Dairy topical administration for 12 weeks; Other Names: KV-0132
Experimental: Middle dose group; Topical administration of middle dose of KPN2002	Drug: KNP2002; Dairy topical administration for 12 weeks; Other Names: KV-0132
Experimental: High dose group; Topical administration of high dose of KPN2002	Drug: KNP2002; Dairy topical administration for 12 weeks; Other Names: KV-0132
Placebo Comparator: Placebo group; Topical administration of placebo	Drug: Placebo of KNP2002; Dairy topical administration for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wart area	Percent change in wart area from baseline	At 16 weeks after starting administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KinoPharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Common Wart
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: OM202JA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No