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

Phase 3

Active, not recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: KX-826-（5%） BID; Other: Placebo

• Registration Number: NCT06126965
• Lead Sponsor: Suzhou Kintor Pharmaceutical Inc,

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-12-29
• Study First Submitted: 2023-10-29
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 740

Inclusion Criteria

1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
2. Male, ≥ 18 old;
3. Clinically diagnosed as androgenetic alopecia;
4. Rating IIIv, IV and V on Hamilton-Norwood scale;

Exclusion Criteria

1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
2. Have used minoxidil within 6 months prior to screening;
3. Have used finasteride or dutasteride within 12 months prior to screening;
4. Had used topical drugs for alopecia sites within 3 months prior to screening;
5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KX-826-0.5% BID	KX-826-（5%） BID	treatment dose group of 0.5% 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 in comparison to placebo).	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 in comparison to placebo).

Secondary Outcome Measures

Name	Time	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 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)
Secondary Outcome Measure:	change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method	Hair growth assessment (HGA) of patient self-assessment, and Hair growth assessment (HGA) of investigator assessment

Trial Locations

Locations (26)

Beijing Friendship Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Dermatology Hospital; 🇨🇳 Shanghai, Shanghai, China

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

The Second Hospital Of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Beijing Tongren Hospital,Cmu; 🇨🇳 Beijing, Beijing, China

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

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

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

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine; 🇨🇳 Zhejiang, Hangzhou, China

The First Hospital Of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital Of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Wuhan Hospital Of Traditional Chinese And Western Medicine; 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital Of Central South University; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

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

The First Hospital Of China Medical University; 🇨🇳 Shenyang, Liaoning, China

West China Hospital Sichuan University; 🇨🇳 Chengdou, Sichuan, China

Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital; 🇨🇳 Tianjin, Tianjin, China

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

Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

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

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