A Phase II Clinical Trial of KNP2002 (OM202JA)

• Sponsor: KinoPharma Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05896215
• Collaborator: (none)
• Enrollment: 160
• Arms: 4
• Anticipated Duration (Months): 11.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Common Wart	Drug: KNP2002; Drug: Placebo of KNP2002	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Trial of KNP2002 Ointment in Patients With Common Warts (OM202JA)
• Anticipated Study Start Date: Jun 6, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in wart area [At 16 weeks after starting administration]

   Percent change in wart area from baseline

Secondary Outcome Measures

1. Change in wart area over time [At 4, 8, 12, and 16 weeks after starting administration]

   Percent change in wart area from baseline

2. Wart improvement rate [At 4, 8, 12, and 16 weeks after starting administration]

   Wart improvement rate categorized by rate of change in wart area

3. Wart disappearance rate [Up to 16 weeks after starting administration]

   Proportion of patients with warts disappearing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• KinoPharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: KinoPharma Inc.
• ClinicalTrials.gov Identifier: NCT05896215
• Other Study ID Numbers: OM202JA
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by KinoPharma Inc.: Common Wart
• Additional relevant MeSH terms: Warts

Study Results

No Results Posted as of Jun 9, 2023