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

Androgenetic Alopecia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06126965
• Other study ID #: KX0826-CN-1003
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 29, 2021
• Est. completion date: May 31, 2024

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 740
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Suzhou Kintor Pharmaceutical Inc,	Suzhou Koshine Biomedica, 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 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	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
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