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

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: CKD-843 dose#1; Drug: Placebo of Dutasteride Capsule; Drug: CKD-843 dose#2; Drug: Placebo of CKD-843 dose; Drug: Dutasteride Capsules

Detailed Description

The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: OhSang Kwon, MD, PhD; Phone Number: +2-2072-2417; Email: oskwon@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
    • Contact: OhSang Kwon, MD, PhD; Phone Number: +2-2072-2417; Email: oskwon@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Male of age 18-50 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group1; CKD-843 dose#1 + Placebo of Dutasteride Capsule	Drug: CKD-843 dose#1; IM injection every 3 months for 12 months; Drug: Placebo of Dutasteride Capsule; oral, once daily, 12 months
Experimental: Test Group2; CKD-843 dose#2 + Placebo of Dutasteride Capsule	Drug: Placebo of Dutasteride Capsule; oral, once daily, 12 months; Drug: CKD-843 dose#2; IM injection every 3 months for 12 months
Placebo Comparator: Placebo-controlled Group; Placebo of CKD-843 dose + Placebo of Dutasteride Capsule	Drug: Placebo of Dutasteride Capsule; oral, once daily, 12 months; Drug: Placebo of CKD-843 dose; IM injection every 3 months for 12 months
Active Comparator: Active-controlled Group; Placebo of CKD-843 dose + Dutasteride Capsules	Drug: Placebo of CKD-843 dose; IM injection every 3 months for 12 months; Drug: Dutasteride Capsules; oral, once daily, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of hair Changes	from Baseline at Week24 of total number of hair changes	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: OhSang Kwon, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): September 17, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: A107_03AGA2318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No