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

• ClinicalTrials.gov Identifier: NCT05940506
• Recruitment Status: Completed
• First Posted: July 11, 2023
• Last Update Posted: July 19, 2023
• Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Information provided by (Responsible Party): Suzhou Kintor Pharmaceutical Inc,

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China
• Actual Study Start Date: September 28, 2020
• Actual Primary Completion Date: July 8, 2021
• Actual Study Completion Date: August 18, 2021

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

1. 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 ]
   change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24).

Secondary Outcome Measures :

1. 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 ]
   Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment
2. 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 ]
   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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male, aged ≥ 18 years, in good general health
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Beijing

Peking University First Hospital

Beijing, Beijing, China

Peking University People's Hospital

Beijing, Beijing, China

China, Guangdong

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

China, Jiangsu

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

China, Shanghai

Huashan Hospital

Shanghai, Shanghai, China

Shanghai Dermatology Hospital

Shanghai, Shanghai, China

China, Tianjin

Tianjin Medical University General Hospital

Tianjin, Tianjin, China

China, Zhejiang

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

More Information

• Responsible Party: Suzhou Kintor Pharmaceutical Inc,
• ClinicalTrials.gov Identifier: NCT05940506
• Other Study ID Numbers: KX0826-CN-1002
• First Posted: July 11, 2023
• Last Update Posted: July 19, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suzhou Kintor Pharmaceutical Inc,:

KX-826 AGA

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical