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OM202JP Clinical Study of KNP2002

Primary Purpose

Common Wart

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KNP2002
Placebo of KNP2002
Sponsored by
KinoPharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Wart focused on measuring Common Wart

Eligibility Criteria

15 Years - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kawaharamachi DermatologyRecruiting
  • Tetsuya DermatologyRecruiting
  • Takashima DermatologyRecruiting
  • Nishino Dermatology ClinicRecruiting
  • Queen's Square, Dermatology, AllergyRecruiting
  • Asai Dermatology ClinicRecruiting
  • Okawa Dermatology ClinicRecruiting
  • Sugai Dermatology Parkside ClinicRecruiting
  • Tsunoda ClinicRecruiting
  • Sugisawa Dermatology ClinicRecruiting
  • Igarashi ClinicRecruiting
  • Maruyama Dermatology ClinicRecruiting
  • Todoroki Dermatology ClinicRecruiting
  • Okuda Dermatology ClinicRecruiting
  • Hayami DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose group

Middle dose group

High dose group

Placebo group

Arm Description

Topical administration of low dose of KPN2002

Topical administration of middle dose of KPN2002

Topical administration of high dose of KPN2002

Topical administration of placebo

Outcomes

Primary Outcome Measures

Change in wart area
Percent change in wart area from baseline

Secondary Outcome Measures

Change in wart area over time
Percent change in wart area from baseline
Wart improvement rate
Wart improvement rate categorized by rate of change in wart area
Wart disappearance rate
Proportion of patients with warts disappearing

Full Information

First Posted
May 31, 2023
Last Updated
June 15, 2023
Sponsor
KinoPharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05896215
Brief Title
OM202JP Clinical Study of KNP2002
Official Title
A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KinoPharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Wart
Keywords
Common Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Topical administration of low dose of KPN2002
Arm Title
Middle dose group
Arm Type
Experimental
Arm Description
Topical administration of middle dose of KPN2002
Arm Title
High dose group
Arm Type
Experimental
Arm Description
Topical administration of high dose of KPN2002
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Topical administration of placebo
Intervention Type
Drug
Intervention Name(s)
KNP2002
Other Intervention Name(s)
KV-0132
Intervention Description
Dairy topical administration for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of KNP2002
Intervention Description
Dairy topical administration for 12 weeks
Primary Outcome Measure Information:
Title
Change in wart area
Description
Percent change in wart area from baseline
Time Frame
At 16 weeks after starting administration
Secondary Outcome Measure Information:
Title
Change in wart area over time
Description
Percent change in wart area from baseline
Time Frame
At 4, 8, 12, and 16 weeks after starting administration
Title
Wart improvement rate
Description
Wart improvement rate categorized by rate of change in wart area
Time Frame
At 4, 8, 12, and 16 weeks after starting administration
Title
Wart disappearance rate
Description
Proportion of patients with warts disappearing
Time Frame
Up to 16 weeks after starting administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katsuhiko Sato, Ph.D.
Phone
+81-3-6264-9604
Email
k.sato@kinopharma.com
Facility Information:
Facility Name
Kawaharamachi Dermatology
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0046
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tetsuya Dermatology
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
672-8084
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takashima Dermatology
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishino Dermatology Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0065
Country
Japan
Individual Site Status
Recruiting
Facility Name
Queen's Square, Dermatology, Allergy
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Individual Site Status
Recruiting
Facility Name
Asai Dermatology Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
240-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okawa Dermatology Clinic
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8301
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugai Dermatology Parkside Clinic
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
321-2471
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsunoda Clinic
City
Arakawa-Ku
State/Province
Tokyo
ZIP/Postal Code
116-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugisawa Dermatology Clinic
City
Katsushika-Ku
State/Province
Tokyo
ZIP/Postal Code
125-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Igarashi Clinic
City
Kita-Ku
State/Province
Tokyo
ZIP/Postal Code
115-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Maruyama Dermatology Clinic
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Individual Site Status
Recruiting
Facility Name
Todoroki Dermatology Clinic
City
Nakano-Ku
State/Province
Tokyo
ZIP/Postal Code
164-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okuda Dermatology Clinic
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
157-0062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hayami Dermatology
City
Osaka
ZIP/Postal Code
537-0013
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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OM202JP Clinical Study of KNP2002

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