NCT05940506 - Phase II Study Evaluating the Efficacy and Safety of KX-826 | Crick

Overview

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Androgenetic Alopecia (AGA)

Interventions

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

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 QDDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

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

Outcomes

Primary Outcomes

change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).

Time frame: mean change from baseline after 24 weeks of treatment

Secondary Outcomes

Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment

Time frame: change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method

Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)

Time frame: change from baseline after 6, 12, 18, and 24 weeks of treatment