A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05677438

Collaborator

(none)

120

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Drug: CKD-498 dose#1 Drug: CKD-498 dose#2 Drug: CKD-498 dose#3 Drug: Placebo of CKD-498 dose#1 Drug: Placebo of CKD-498 dose#2 Drug: Placebo of CKD-498 dose#3	Phase 2

Detailed Description

Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-498 in Female Patients With Androgenetic Alopecia

Actual Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group1	Drug: CKD-498 dose#1 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#2 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#3 oral, once daily, 24 weeks
Experimental: Test Group2	Drug: CKD-498 dose#2 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#1 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#3 oral, once daily, 24 weeks
Experimental: Test Group3	Drug: CKD-498 dose#3 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#1 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#2 oral, once daily, 24 weeks
Placebo Comparator: Placebo Group	Drug: Placebo of CKD-498 dose#1 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#2 oral, once daily, 24 weeks Drug: Placebo of CKD-498 dose#3 oral, once daily, 24 weeks

Outcome Measures

Primary Outcome Measures

Total number of hair Changes [Baseline, Week 24]
from Baseline at Week24 of total number of hair changes

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 54 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Female of age 19-54 years
Clinical Diagnosis of Androgenetic Alopecia
Written informed consent

Key Exclusion Criteria:

Other types of Alopecia or other diseases that can cause hair loss
Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
Women who are pregnant or breastfeeding
Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Gyeonggi-do		Korea, Republic of	13620

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

Investigators

Principal Investigator: ChangHun Huh, MD, PhD., Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT05677438

Other Study ID Numbers:

A128_01AGA2211

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 12, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chong Kun Dang Pharmaceutical

Androgenetic Alopecia

CKD-498

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Study Results

No Results Posted as of Jan 12, 2023