A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration

Suzhou Kintor Pharmaceutical Inc,9 sites in 1 country123 target enrollmentJanuary 31, 2022

ConditionsAlopecia Male Pattern Hair Loss

InterventionsKX- 826 dosed at 2.5mg KX-826 dosed at 5mg Matching placebo to KX-826

DrugsKX-826 dosed at 5mg KX- 826 dosed at 2.5mg Matching placebo to KX-826

Overview

Phase: Phase 2
Intervention: KX- 826 dosed at 2.5mg
Conditions: Alopecia
Sponsor: Suzhou Kintor Pharmaceutical Inc,
Enrollment: 123
Locations: 9
Primary Endpoint: Assessment of change in Target Area Hair Counts
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.

Detailed Description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC （Target Area Hair Counts）at Week 24 in comparison to placebo

Registry

clinicaltrials.gov

Start Date

January 31, 2022

End Date

February 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Suzhou Kintor Pharmaceutical Inc,

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is capable of giving informed consent and complying with study procedures;
•Subject is male between the ages of 18 and 70 years, inclusive;
•Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
•Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
•Subject agrees to continue his other general hair care products and regimen for the entire study;
•Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and
•≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate
•≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range values);
•Negative COVID-19 results within 3 days prior first dosing

Exclusion Criteria

•Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;
•Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
•Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
•Subject had scalp hair transplants at any time
•Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
•Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss;
•Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
•Affect the safety of the subject throughout the study
•Influence the findings of the studies or their interpretations
•Impede the subject's ability to complete the entire duration of study