NCT06622824

To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia

Efficacy and Safety of Topical KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia: A Multicenter, Randomized, Double-blind, Vehicle Controlled Adaptive Design Phase 2/3 Study

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 756 (estimated)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.

Detailed description

In phase 2 study, around 90 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (30 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation. A Phase 2 statistical analysis will be performed when 90 patients complete the Week 24 visit or early withdrawal visit. Blood samples will be collected at the following time points: Day 1: 3 hours (pre-dose) W6 (Day 42): 3 hours (pre-dose) W12 (Day 84): 3 hours (pre-dose) In phase 3 study, around 666 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (222 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Conditions

• Androgenetic Alopecia (AGA)

Interventions

Type	Name	Description
DRUG	KX-826 0.5% BID	0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
DRUG	KX-826 1.0% BID	1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
DRUG	Vehicle (Placebo) applied BID	Matching placebo applied topically to scalp twice daily for 24 weeks

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-10-20
• Completion: 2028-06-30
• First posted: 2024-10-02
• Last updated: 2024-10-21

Locations

1 site across 1 country: China