Clinical trial NCT06126965: Phase III Study of KX-826 With Adult Male Patients With AGA
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Androgenetic Alopecia
Keywords: KX-826
AGA
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,
Sponsor class: INDUSTRY
Collaborators: name: Suzhou Koshine Biomedica, Inc.
First posted: 2023-11-13
Enrollment: 740
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
timeFrame: mean change from baseline after 24 weeks of treatment
Secondary outcomes:
measure: Secondary Outcome Measure:
timeFrame: change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method
measure: Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
timeFrame: change from baseline after 6, 12, 18, and 24 weeks of treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital,Cmu
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhejiang
country: China
facility: Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine
state: Hangzhou
city: Shijiazhuang
country: China
facility: The First Hospital Of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital Of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Hospital Of Traditional Chinese And Western Medicine
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Chengdou
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Qinping Yang
role: PRINCIPAL_INVESTIGATOR
References: