Phase II Study Evaluating the Efficacy and Safety of KX-826
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| 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.
|
| Placebo Comparator: Placebo 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.
|
Outcome Measures
Primary Outcome Measures
- 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]
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).
Secondary Outcome Measures
- 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]
Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
- 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]
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
-
Male, aged ≥ 18 years, in good general health;
-
Clinical diagnosis of AGA;
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Stage IIIv, IV and V according to Hamilton-Norwood scale.
Exclusion Criteria:
-
Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
-
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;
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Minoxidil use within 6 months prior to screening;
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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;
-
Other conditions that may affect compliance or ineligibility for participation of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | |
| 2 | Peking University People's Hospital | Beijing | Beijing | China | |
| 3 | Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China | |
| 4 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | |
| 5 | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China | |
| 6 | Huashan Hospital | Shanghai | Shanghai | China | |
| 7 | Shanghai Dermatology Hospital | Shanghai | Shanghai | China | |
| 8 | Tianjin Medical University General Hospital | Tianjin | Tianjin | China | |
| 9 | The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Suzhou Kintor Pharmaceutical Inc,
Investigators
- Principal Investigator: Jianzhong Zhang, Peking University People's Hospital
- Principal Investigator: Qinping Yang, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KX0826-CN-1002