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

NCT ID: NCT05940506

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-08-18

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.

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.

Conditions

Androgenetic Alopecia (AGA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KX-826-2.5 mg BID

treatment dose groups of 2.5 mg BID (0.25%)

Group Type: EXPERIMENTAL

KX-826-2.5 mg (0.25%)/60 mL BID

Intervention Type: DRUG

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 QD

treatment dose groups of 5 mg QD (0.5%)

Group Type: EXPERIMENTAL

KX-826-5 mg (5%)/60 mL QD

Intervention Type: DRUG

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 BID

treatment dose groups of 5 mg BID (0.5%)

Group Type: EXPERIMENTAL

KX-826-5 mg (5%)/60 mL BID

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

KX-826-2.5 mg (0.25%)/60 mL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Kintor Pharmaceutical Inc,

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Qinping Yang

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

KX0826-CN-1002

Identifier Type: -

Identifier Source: org_study_id