Phase II Study Evaluating the Efficacy and Safety of KX-826

Phase 2

Completed

• Conditions: Androgenetic Alopecia (AGA)
• Interventions: Drug: KX-826-2.5 mg (0.25%)/60 mL BID; Drug: KX-826-5 mg (5%)/60 mL QD; Drug: KX-826-5 mg (5%)/60 mL BID; Other: Placebo

• Registration Number: NCT05940506
• Lead Sponsor: Suzhou Kintor Pharmaceutical Inc,

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

Detailed Description

Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.

Study Timeline

• Study Start: 2020-09-28
• Primary Completion: 2021-07-08
• Study Completion: 2021-08-18
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-11
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
2. Male, aged ≥ 18 years, in good general health;
3. Clinical diagnosis of AGA;
4. Stage IIIv, IV and V according to Hamilton-Norwood scale.

Exclusion Criteria

1. Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
2. Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
3. Minoxidil use within 6 months prior to screening;
4. Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
5. Other conditions that may affect compliance or ineligibility for participation of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KX-826-2.5 mg BID	KX-826-2.5 mg (0.25%)/60 mL BID	treatment dose groups of 2.5 mg BID (0.25%)
KX-826-5 mg QD	KX-826-5 mg (5%)/60 mL QD	treatment dose groups of 5 mg QD (0.5%)
KX-826-5 mg BID	KX-826-5 mg (5%)/60 mL BID	treatment dose groups of 5 mg BID (0.5%)
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).	mean change from baseline after 24 weeks of treatment	change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).

Secondary Outcome Measures

Name	Time	Method
Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment	change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method	Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)	change from baseline after 6, 12, 18, and 24 weeks of treatment	Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)

Trial Locations

Locations (9)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China

Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Shanghai Dermatology Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China