NCT06126965|UnknownPhase 3

Phase III Study of KX-826 With Adult Male Patients With AGA

A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of KX-826 for Topical Use in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)

Suzhou Kintor Pharmaceutical Inc,ClinicalTrials.gov

Compare

1 other identifier

KX0826-CN-1003

Study Type

interventional

Target

740

Locations

1 country

Sites

Timeline

RegisteredNov 2023

StartedDec 2021

CompletionMay 2024

Brief Summary

This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

740

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2021

Geographic Reach

1 country

26 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

December 29, 2021

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed

Last Updated

April 3, 2024

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

October 29, 2023

Last Update Submit

April 1, 2024

Conditions

Androgenetic Alopecia

Keywords

KX-826AGA

Outcome Measures

Primary Outcomes (1)

change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
mean change from baseline after 24 weeks of treatment

Secondary Outcomes (2)

Secondary Outcome Measure:
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 (2)

KX-826-0.5% BID

EXPERIMENTAL

treatment dose group of 0.5% BID(0.5%)

Drug: KX-826-（5%） BID

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

KX-826-（5%） BIDDRUG

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening.

Also known as: KX-826-5 mg(5%)60mL BID

KX-826-0.5% BID

PlaceboOTHER

Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening.

Placebo

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsMale, aged ≥ 18 years, in good general health;

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
Male, ≥ 18 old;
Clinically diagnosed as androgenetic alopecia;
Rating IIIv, IV and V on Hamilton-Norwood scale;

You may not qualify if:

Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
Have used minoxidil within 6 months prior to screening;
Have used finasteride or dutasteride within 12 months prior to screening;
Had used topical drugs for alopecia sites within 3 months prior to screening;
Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Suzhou Kintor Pharmaceutical Inc,lead
Suzhou Koshine Biomedica, Inc.collaborator

Study Sites (26)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Friendship Hospital,Capital Medical University