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

Androgenetic Alopecia (AGA) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05940506
• Other study ID #: KX0826-CN-1002
• Status: Completed
• Phase: Phase 2
• Start date: September 28, 2020
• Est. completion date: August 18, 2021

Study information

• Verified date: July 2023
• Source: Suzhou Kintor Pharmaceutical Inc,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 18, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia (AGA)

Intervention

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.
• 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.
• 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.

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	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	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Huashan Hospital	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Kintor Pharmaceutical Inc,

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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