NCT06409650

To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of KX-826 Tincture for Topical Use in Chinese Adult Female Patients With Androgenetic Alopecia (AGA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Suzhou Koshine Biomedica, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.

Detailed description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of female pattern hair loss (androgenetic alopecia). A total of 160 female subjects were randomized to one of four cohorts: 2.5 mg QD, 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

Interventions

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

Timeline

• Start date: 2021-11-09
• Primary completion: 2022-11-10
• Completion: 2023-12-07
• First posted: 2024-05-10
• Last updated: 2024-05-22

Locations

15 sites across 1 country: China