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

NCT05677438 | Completed Phase 2

• 1 other identifier: A128_01AGA2211
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Androgenetic Alopecia

Keywords

Androgenetic Alopecia; CKD-498

Outcome Measures

Primary Outcomes (1)

• Total number of hair Changes

  from Baseline at Week24 of total number of hair changes

  Baseline, Week 24

Study Arms (4)

Test Group1

EXPERIMENTAL

Drug: CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2; Drug: Placebo of CKD-498 dose#3

Test Group2

EXPERIMENTAL

Drug: CKD-498 dose#2; Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#3

Test Group3

EXPERIMENTAL

Drug: CKD-498 dose#3; Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#2; Drug: Placebo of CKD-498 dose#3

Interventions

CKD-498 dose#1 DRUG

oral, once daily, 24 weeks

Test Group1

CKD-498 dose#2 DRUG

oral, once daily, 24 weeks

Test Group2

CKD-498 dose#3 DRUG

oral, once daily, 24 weeks

Test Group3

Placebo of CKD-498 dose#1 DRUG

oral, once daily, 24 weeks

Placebo Group; Test Group2; Test Group3

Placebo of CKD-498 dose#2 DRUG

oral, once daily, 24 weeks

Placebo Group; Test Group1; Test Group3

Placebo of CKD-498 dose#3 DRUG

oral, once daily, 24 weeks

Placebo Group; Test Group1; Test Group2

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• ChangHun Huh, MD, PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: December 20, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)