NCT05218642

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.

Detailed description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC （Target Area Hair Counts）at Week 24 in comparison to placebo

Conditions

• Alopecia
• Male Pattern Hair Loss

Interventions

Type	Name	Description
DRUG	KX- 826 dosed at 2.5mg	2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
DRUG	KX-826 dosed at 5mg	5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
DRUG	KX-826 dosed at 5mg	5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
DRUG	Matching placebo to KX-826	Placebo applied topically to scalp twice daily or once daily for 24 weeks

Timeline

• Start date: 2022-01-31
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2022-02-01
• Last updated: 2023-11-22

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study