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

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: KX-826-（5%） BID; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 740
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China
      • Beijing Friendship Hospital,Capital Medical University
    • Beijing, Beijing, China
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China
      • Peking University First Hospital
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing, China
      • Beijing Tongren Hospital,CMU
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Shenzhen, Guangdong, China
      • ShenZhen People's Hospital
  • Hangzhou
    • Zhejiang, Hangzhou, China
      • Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
  • Hebei
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Hospital Of Traditional Chinese And Western Medicine
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Dermatology Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital
  • Sichuan
    • Chengdou, Sichuan, China
      • West China Hospital Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 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.
Experimental: KX-826-0.5% BID; treatment dose group of 0.5% BID(0.5%)	Drug: KX-826-（5%） BID; 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.; Other Names: KX-826-5 mg(5%)60mL BID

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 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
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
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

Collaborators and Investigators

• Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Collaborators: Suzhou Koshine Biomedica, Inc.
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital; Principal Investigator: Qinping Yang, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: AGA; KX-826
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: KX0826-CN-1003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No