To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia

NCT06622824 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KX0826-CN-1010
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.

Conditions

Androgenetic Alopecia (AGA)

Keywords

androgenetic alopecia; Hair loss

Outcome Measures

Primary Outcomes (1)

• Target Area Non-vellus Hair count (TAHC) change from baseline at week 24 in comparison to vehicle.

  Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)

  24 weeks

Secondary Outcomes (4)

• Hair Growth Assessment (HGA)

  6 weeks, 12 weeks, 18 weeks and 24 weeks

• Target Area Non-vellus Hair diameter (TAHW) assessment

  6 weeks, 12 weeks, 18 weeks and 24 weeks

• Target Area total hair counts

  6 weeks, 12 weeks, 18 weeks and 24 weeks

• TAHC assessment

  6 weeks, 12 weeks, 18 weeks

Study Arms (3)

Arm A

EXPERIMENTAL

KX-826 0.5% BID

Drug: KX-826 0.5% BID

Arm B

EXPERIMENTAL

KX-826 1.0% BID

Drug: KX-826 1.0% BID

Arm C

PLACEBO COMPARATOR

Matching Vehicle

Drug: Vehicle (Placebo) applied BID

Interventions

KX-826 0.5% BID DRUG

0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks

Arm A

KX-826 1.0% BID DRUG

1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks

Arm B

Vehicle (Placebo) applied BID DRUG

Matching placebo applied topically to scalp twice daily for 24 weeks

Arm C

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Agree to comply with study procedures and visit plan. Subject is capable of giving informed consent;
• Male between the ages of 18 and 49 years, inclusive;
• Clinically diagnosed as androgenetic alopecia;
• Rating IIIv, IV and V on the Norwood Hamilton Scale; subject is willing to receive a ink dot tattoo;
• Subject is willing to maintain the same hairstyle, hair length, and hair color at each visit;
• Willing to use highly effective contraceptive measures during the study period and 3 months after the last dose.

You may not qualify if:

• Had a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA;
• Had gray hair in the target alopecia area;
• Had too short hair that, in the investogator's opinion, might affect hair growth assessment;
• Had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug (e.g., fungal or bacterial infection, severe seborrheic dermatitis, solar keratosis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy);
• Had a significant increase in hair loss determined by investigator within 6 months prior to screening;
• Had scalp hair transplants or hair extension history; need of wearing wig for a long time during the study;
• Subjects who plan to use any adjuvant or concomitant therapy for the treatment of alopecia throughout the study;
• Subjects with a previous or current diagnosis of hyperthyroidism or hypothyroidism;
• Subjects with diseases that affect hair growth, such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia, and significant short-term weight loss;
• Had used finasteride or dutasteride prior to screening;
• Had used platelet rich plasma (PRP) procedure within 12 months prior to screening;
• Had used scalp surgical procedure within 12 months prior to screening; Had used laser, light, or energy treatments within 6 months of screening;
• Had used anti-androgenic drugs (e.g., flutamide, cyproterone, drospirosterone, estrogen, progesterone, cimetidine, spironolactone, or oral ketoconazole, etc) within 6 months prior to screening;
• Had used the following medications that may affect the evaluation of efficacy in the study within 6 months prior to screening:
• Oral or topical minoxidil

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Alopecia

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoyan Ni

CONTACT

+86 15050402391; xyni@kintor.com.cn

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

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)