Clincosm LogoSign in Get a demo

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

Sponsor
Suzhou Kintor Pharmaceutical Inc, (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06126965
Collaborator
Suzhou Koshine Biomedica, Inc. (Industry)
740
Enrollment
26
Locations
2
Arms
29
Anticipated Duration (Months)
28.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: KX-826-（5%） BID
  • Other: Placebo
 Phase 3

Detailed Description

In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Study Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Dec 29, 2021
Anticipated Primary Completion Date :
Jan 11, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: KX-826-0.5% BID

treatment dose group of 0.5% BID(0.5%)

Drug: KX-826-（5%） BID
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.
Other Names:
  • KX-826-5 mg(5%)60mL BID

    		•
    Placebo Comparator: Placebo

    Placebo

    Other: Placebo
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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]

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

    Secondary Outcome Measures

    1. Secondary Outcome Measure: [change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method]

      Hair growth assessment (HGA) of patient self-assessment, and Hair growth assessment (HGA) of investigator 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) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;

    2. Male, ≥ 18 old;

    3. Clinically diagnosed as androgenetic alopecia;

    4. Rating IIIv, IV and V on Hamilton-Norwood scale;

    Exclusion Criteria:

    1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;

    2. Have used minoxidil within 6 months prior to screening;

    3. Have used finasteride or dutasteride within 12 months prior to screening;

    4. Had used topical drugs for alopecia sites within 3 months prior to screening;

    5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;

    6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital Of Anhui Medical University Hefei Anhui China
    2 Beijing Friendship Hospital,Capital Medical University Beijing Beijing China
    3 Beijing Tongren Hospital,Cmu Beijing Beijing China
    4 Beijing Tsinghua Changgung Hospital Beijing Beijing China
    5 China-Japan Friendship Hospital Beijing Beijing China
    6 Peking University First Hospital Beijing Beijing China
    7 Peking University People's Hospital Beijing Beijing China
    8 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China
    9 Dermatology Hospital of Southern Medical University Guangzhou Guangdong China
    10 Guangdong Provincial People's Hospital Guangzhou Guangdong China
    11 Shenzhen People's Hospital Shenzhen Guangdong China
    12 Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine Zhejiang Hangzhou China
    13 The First Hospital Of Hebei Medical University Shijiazhuang Hebei China
    14 The First Affiliated Hospital Of Zhengzhou University Zhengzhou Henan China
    15 Wuhan Hospital Of Traditional Chinese And Western Medicine Wuhan Hubei China
    16 The Second Xiangya Hospital Of Central South University Changsha Hunan China
    17 Xiangya Hospital Central South University Changsha Hunan China
    18 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China
    19 The First Hospital Of China Medical University Shenyang Liaoning China
    20 Huashan Hospital Shanghai Shanghai China
    21 Shanghai Dermatology Hospital Shanghai Shanghai China
    22 West China Hospital Sichuan University Chengdou Sichuan China
    23 Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital Tianjin Tianjin China
    24 Tianjin Medical University General Hospital Tianjin Tianjin China
    25 Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine Hangzhou Zhejiang China
    26 The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Suzhou Kintor Pharmaceutical Inc,
    • Suzhou Koshine Biomedica, Inc.

    Investigators

    • Principal Investigator: Jianzhong Zhang, Peking University People's Hospital
    • Principal Investigator: Qinping Yang, Huashan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzhou Kintor Pharmaceutical Inc,
    ClinicalTrials.gov Identifier:
    NCT06126965
    Other Study ID Numbers:
    • KX0826-CN-1003
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 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

    Study Results

    No Results Posted as of Nov 13, 2023