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

NCT05940506 | Completed Phase 2

• 1 other identifier: KX0826-CN-1002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

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.

Conditions

Androgenetic Alopecia (AGA)

Keywords

KX-826 AGA

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (2)

• 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

• 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

Study Arms (4)

KX-826-2.5 mg BID

EXPERIMENTAL

treatment dose groups of 2.5 mg BID (0.25%)

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

KX-826-5 mg QD

EXPERIMENTAL

treatment dose groups of 5 mg QD (0.5%)

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

KX-826-5 mg BID

EXPERIMENTAL

treatment dose groups of 5 mg BID (0.5%)

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

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

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

Also known as: KX-826-2.5 mg (0.25%)/60 mL

KX-826-2.5 mg BID

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

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

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male, aged ≥ 18 years, in good general health
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Stage IIIv, IV and V according to Hamilton-Norwood scale.

You may not qualify if:

• 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;
• Minoxidil use within 6 months prior to screening;
• 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.

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (9)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Qinping Yang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: September 28, 2020
• Primary Completion: July 8, 2021
• Study Completion: August 18, 2021
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

CN (9)