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

Study Overview
=================
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.

Official Title
-----------------
A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China

Conditions
-----------------
Androgenetic Alopecia (AGA)

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing; Male, aged ≥ 18 years, in good general health; Clinical diagnosis of AGA; Stage IIIv, IV and V according to Hamilton-Norwood scale. Exclusion Criteria: Patients who have used external topical drugs for alopecia sites within 3 months prior to screening; 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; Minoxidil use within 6 months prior to screening; 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; Other conditions that may affect compliance or ineligibility for participation of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KX-826-2.5 mg BID<br>treatment dose groups of 2.5 mg BID (0.25%) | Drug: KX-826-2.5 mg (0.25%)/60 mL BID<br>* Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.<br>* Other names: KX-826-2.5 mg (0.25%)/60 mL;|
| Experimental: KX-826-5 mg QD<br>treatment dose groups of 5 mg QD (0.5%) | Drug: KX-826-5 mg (5%)/60 mL QD<br>* Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily.<br>|
| Experimental: KX-826-5 mg BID<br>treatment dose groups of 5 mg BID (0.5%) | Drug: KX-826-5 mg (5%)/60 mL BID<br>* Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24). | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment | 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 | 
| Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 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) | change from baseline after 6, 12, 18, and 24 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KX-826 AGA