A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

NCT06916793 | Not Yet Recruiting Phase 3

• 1 other identifier: A107_03AGA2318
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Conditions

Androgenetic Alopecia

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

CKD-843 dose#1 + Placebo of Dutasteride Capsule

Drug: CKD-843 dose#1; Drug: Placebo of Dutasteride Capsule

Test Group2

EXPERIMENTAL

CKD-843 dose#2 + Placebo of Dutasteride Capsule

Drug: CKD-843 dose#2; Drug: Placebo of Dutasteride Capsule

Placebo-controlled Group

PLACEBO COMPARATOR

Placebo of CKD-843 dose + Placebo of Dutasteride Capsule

Drug: Placebo of CKD-843 dose; Drug: Placebo of Dutasteride Capsule

Active-controlled Group

ACTIVE COMPARATOR

Placebo of CKD-843 dose + Dutasteride Capsules

Drug: Placebo of CKD-843 dose; Drug: Dutasteride Capsules

Interventions

CKD-843 dose#1 DRUG

IM injection every 3 months for 12 months

Test Group1

CKD-843 dose#2 DRUG

IM injection every 3 months for 12 months

Test Group2

Placebo of CKD-843 dose DRUG

IM injection every 3 months for 12 months

Active-controlled Group; Placebo-controlled Group

Dutasteride Capsules DRUG

oral, once daily, 12 months

Active-controlled Group

Placebo of Dutasteride Capsule DRUG

oral, once daily, 12 months

Placebo-controlled Group; Test Group1; Test Group2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male of age 18-50 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
• Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alopecia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• OhSang Kwon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OhSang Kwon, MD, PhD

CONTACT

+2-2072-2417; oskwon@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): September 17, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)