To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia

Last updated: May 20, 2024
Sponsor: Suzhou Koshine Biomedica, Inc.
Overall Status: Completed

Phase

2

Condition

Hair Loss

Alopecia

Treatment

KX-826

Matching placebo to KX-826

KX-826 dosed at 2.5mg

Clinical Study ID

NCT06409650
KX0826-CN-1004
  • Ages > 18
  • Female

Study Summary

This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who meet all of the following criteria may be included in this study:
  1. Agree to follow the study treatment regimen and visit plan, voluntarily enrollin the study and sign the ICF in writing;

  2. Female, ≥ 18 years old;

  3. Clinically diagnosed as androgenetic alopecia;

  4. Alopecia severity was Ggraded D3-D6 according toon Savin scale;

  5. Willing to maintain the same hair style, color and length at each follow-upvisit;

  6. Have no pregnancy plan and agree to take highly effective contraceptivesthroughout the study and within 3 months after the last dose. Women ofchildbearing potential must have a negative serum pregnancy test within 7 daysprior to the first dose of study drug.

Exclusion

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from the study:
  1. Medical/surgical history of any uncontrolled serious clinical system diseases,which may affect the safety and efficacy evaluation of the study drug, such ascirculatory system, nervous system, hematological system, digestive system (e.g., inflammatory bowel disease), immune system, psychiatric disorders, etc.;

  2. Known hair loss disorders other than AGA, such as alopecia areata or diffusealopecia areata, syphilitic alopecia, cicatricial alopecia, malnutrition,alopecia due to chemotherapy/radiotherapy;

  3. Scalp skin diseases that affect the efficacy evaluation, scalp trauma, or otherscalp skin lesions requiring topical drug therapy, such as fungal or bacterialinfection, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis,severe folliculitis and scalp atrophy;

  4. Concomitant diseases that affect hair growth, such as connective tissuedisease, inflammatory bowel disease, moderate to severe anemia and significantshort-term weight loss;

  5. History of hair transplantation or requiring long-term wearing of a wig andhair adhesive during the study treatment;

  6. Have used topical drugs for hair loss sites (including corticosteroids,estrogens, etc.) that may affect the efficacy evaluation for ≥ 2 consecutiveweeks within 3 months prior to screening;

  7. Have used androgen replacement therapy, immunosuppressants and other drugs thatmay affect the efficacy evaluation within 3 months prior to screening;

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

  9. Have used spironolactone or cyproterone within 6 months prior to screening;

  10. Have received autologous platelet-rich plasma therapy for AGA within 12 monthsprior to screening;

  11. Have received chemotherapy and cytotoxic agents within 12 months prior toscreening or have received scalp radiation and/or low-energy laser or scalpsurgery for AGA within 12 months prior to screening;

  12. Have used other medical shampoos or solutions containing ketoconazole orsimilar ingredients (e.g., Terzolin) that may affect the efficacy evaluationwithin 1 month prior to screening;

  13. Plan to use any adjuvant or concomitant therapy for the treatment of alopeciathroughout the study;

  14. Allergic to the study drug or known to be allergic to ingredients of the studydrug;

  15. History of malignant diseases within 5 years prior to screening;

  16. Abnormal and clinically significant findings in physical examination, vitalsigns, 12-lead ECG, hematology, urinalysis, blood chemistry and thyroidfunction test at screening, which will affect the efficacy and safetyevaluation and study results as judged by the investigator;

  17. Positive for any one or more of antibodies of treponema pallidum antibody,human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen orhepatitis C virus antibody;

  18. Have undergone major surgery within 3 months prior to screening, or plan toundergo major surgery during the study;

  19. Have participated in or being participated in clinical studies ofinterventional drugs or medical devices within 3 months prior to screening (except for those who participated in non-interventional studies and those whoonly signed the ICF but did not receive study intervention);

  20. History of drug abuse within 1 year prior to screening, or history of drug useor alcohol dependence within 3 months prior to the study;

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

Study Design

Total Participants: 160
Treatment Group(s): 4
Primary Treatment: KX-826
Phase: 2
Study Start date:
November 09, 2021
Estimated Completion Date:
December 07, 2023

Study Description

KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of female pattern hair loss (androgenetic alopecia). A total of 160 female subjects were randomized to one of four cohorts: 2.5 mg QD, 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.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing,
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha,
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou,
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen,
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Site Not Available

  • Suining Central Hospital

    Suining,
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

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