Phase III Study of KX-826 With Adult Male Patients With AGA

Study Overview
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Brief Summary
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This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

Detailed Description
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In this study, around 740 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 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: KX-826-（5%） BID
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing; Male, ≥ 18 old; Clinically diagnosed as androgenetic alopecia; Rating IIIv, IV and V on Hamilton-Norwood scale; Exclusion Criteria: Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening; Have used minoxidil within 6 months prior to screening; Have used finasteride or dutasteride within 12 months prior to screening; Had used topical drugs for alopecia sites within 3 months prior to screening; Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening; Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KX-826-0.5% BID<br>treatment dose group of 0.5% BID(0.5%) | Drug: KX-826-（5%） BID<br>* Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening.<br>* Other names: KX-826-5 mg(5%)60mL BID;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening.<br>|

What is the study measuring?
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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 in comparison to placebo). | change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo). | mean change from baseline after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measure: | Hair growth assessment (HGA) of patient self-assessment, and Hair growth assessment (HGA) of investigator 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
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Keywords Provided by Centre Hospitalier Valida
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KX-826, AGA