To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

NCT05218642 | Completed Phase 2 FDA Drug

• 1 other identifier: KX0826-US-1003
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 10

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.

Conditions

Alopecia; Male Pattern Hair Loss

Keywords

Androgenetic Alopecia; Hair loss; Hair thinning; Baldness

Outcome Measures

Primary Outcomes (1)

• Assessment of change in Target Area Hair Counts

  Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo

  24 weeks

Secondary Outcomes (1)

• Assessment of change in Hair Growth Assessment score

  6,12,18 and 24 weeks

Study Arms (4)

Arm A

EXPERIMENTAL

KX-826: 2.5mg twice daily

Drug: KX- 826 dosed at 2.5mg

Arm B

EXPERIMENTAL

KX-826: 5mg once daily

Drug: KX-826 dosed at 5mg

Arm C

EXPERIMENTAL

KX-826: 5mg twice daily

Drug: KX-826 dosed at 5mg

Arm D

EXPERIMENTAL

Matching placebo to KX-826

Drug: Matching placebo to KX-826

Interventions

KX- 826 dosed at 2.5mg DRUG

2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks

Arm A

KX-826 dosed at 5mg DRUG

5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks

Arm B

Matching placebo to KX-826 DRUG

Placebo applied topically to scalp twice daily or once daily for 24 weeks

Arm D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subject is currently enrolled in an investigational drug or device study;
• Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization;
• Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function;
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (10)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Qway Research LLC

Hialeah, Florida, 33010, United States

Location

Evoution Clinical Trials

Hialeah Gardens, Florida, 33016, United States

Location

Anchor Medical Research, LLC

Miami, Florida, 33176, United States

Location

Innovation Medical Group, LLC

Palmetto Bay, Florida, 33157, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70808, United States

Location

ALLCUTIS Research, LLC

Beverly, Massachusetts, 01915, United States

Location

ALLCUTIS Research, LLC

Portsmouth, New Hampshire, 03801, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

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 Design

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

Model Details: Assignment

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 1, 2022
• Study Start: January 31, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-06

Locations

US (10)