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

Kintor Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Androgenetic Alopecia (AGA)

Treatments: Other: Placebo; Drug: KX-826-5 mg (5%)/60 mL BID; Drug: KX-826-5 mg (5%)/60 mL QD; Drug: KX-826-2.5 mg (0.25%)/60 mL BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT05940506

KX0826-CN-1002

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

KX-826-2.5 mg BID

Experimental group

Description:

treatment dose groups of 2.5 mg BID (0.25%)

Treatment:

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

KX-826-5 mg QD

Experimental group

Description:

treatment dose groups of 5 mg QD (0.5%)

Treatment:

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

KX-826-5 mg BID

Experimental group

Description:

treatment dose groups of 5 mg BID (0.5%)

Treatment:

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

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo