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

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

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

Study Overview

• Status: Completed
• 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

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University First Hospital
    • Beijing, Beijing, China
      • Peking University People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Dermatology Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 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.
Experimental: KX-826-2.5 mg BID; treatment dose groups of 2.5 mg BID (0.25%)	Drug: KX-826-2.5 mg (0.25%)/60 mL BID; 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.; Other Names: KX-826-2.5 mg (0.25%)/60 mL
Experimental: KX-826-5 mg QD; treatment dose groups of 5 mg QD (0.5%)	Drug: KX-826-5 mg (5%)/60 mL QD; 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.
Experimental: KX-826-5 mg BID; treatment dose groups of 5 mg BID (0.5%)	Drug: KX-826-5 mg (5%)/60 mL BID; 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.

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

Collaborators and Investigators

• Sponsor: Suzhou Kintor Pharmaceutical 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): September 28, 2020
• Primary Completion (Actual): July 8, 2021
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: KX-826 AGA
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: KX0826-CN-1002

Drug and device information, study documents

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