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AlopeciaPhase 2NCT06409650

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

A Phase 2 study testing KX-826 dosed at 2.5mg and KX-826 dosed at 5 mg in people with Alopecia, run by Suzhou Koshine Biomedica, Inc. at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Alopecia
What is being tested?
KX-826 dosed at 2.5mg and KX-826 dosed at 5 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
15 sitesChina
Study dates
9 Nov 2021to 7 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet all of the following criteria may be included in this study:
  • Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study and sign the ICF in writing;
  • Female, ≥ 18 years old;
  • Clinically diagnosed as androgenetic alopecia;
  • Alopecia severity was Ggraded D3-D6 according toon Savin scale;
  • Willing to maintain the same hair style, color and length at each follow-up visit;
  • Have no pregnancy plan and agree to take highly effective contraceptives throughout the study and within 3 months after the last dose. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from the study:
  • Medical/surgical history of any uncontrolled serious clinical system diseases, which may affect the safety and efficacy evaluation of the study drug, such as circulatory system, nervous system, hematological system, digestive system (e.g., inflammatory bowel disease), immune system, psychiatric disorders, etc.;
  • Known hair loss disorders other than AGA, such as alopecia areata or diffuse alopecia areata, syphilitic alopecia, cicatricial alopecia, malnutrition, alopecia due to chemotherapy/radiotherapy;
  • Scalp skin diseases that affect the efficacy evaluation, scalp trauma, or other scalp skin lesions requiring topical drug therapy, such as fungal or bacterial infection, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis and scalp atrophy;
  • Concomitant diseases that affect hair growth, such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia and significant short-term weight loss;
  • History of hair transplantation or requiring long-term wearing of a wig and hair adhesive during the study treatment;
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  • Have used topical drugs for hair loss sites (including corticosteroids, estrogens, etc.) that may affect the efficacy evaluation for ≥ 2 consecutive weeks within 3 months prior to screening;
  • Have used androgen replacement therapy, immunosuppressants 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 spironolactone or cyproterone within 6 months prior to screening;
  • Have received autologous platelet-rich plasma therapy for AGA within 12 months prior to screening;
  • Have received chemotherapy and cytotoxic agents within 12 months prior to screening or have received scalp radiation and/or low-energy laser or scalp surgery for AGA within 12 months prior to screening;
  • Have used other medical shampoos or solutions containing ketoconazole or similar ingredients (e.g., Terzolin) that may affect the efficacy evaluation within 1 month prior to screening;
  • Plan to use any adjuvant or concomitant therapy for the treatment of alopecia throughout the study;
  • Allergic to the study drug or known to be allergic to ingredients of the study drug;
  • History of malignant diseases within 5 years prior to screening;
  • Abnormal and clinically significant findings in physical examination, vital signs, 12-lead ECG, hematology, urinalysis, blood chemistry and thyroid function test at screening, which will affect the efficacy and safety evaluation and study results as judged by the investigator;
  • Positive for any one or more of antibodies of treponema pallidum antibody, human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis C virus antibody;
  • Have undergone major surgery within 3 months prior to screening, or plan to undergo major surgery during the study;
  • Have participated in or being participated in clinical studies of interventional drugs or medical devices within 3 months prior to screening (except for those who participated in non-interventional studies and those who only signed the ICF but did not receive study intervention);
  • History of drug abuse within 1 year prior to screening, or history of drug use or alcohol dependence within 3 months prior to the study;
  • Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • China-Japan Friendship Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Xiangya Hospital Central South University

    Changsha

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Dermatology Hospital of Southern Medical University

    Guangzhou

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

    Hangzhou

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Huashan Hospital, Fudan University

    Shanghai

  • Shenzhen People's Hospital

    Shenzhen

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • Suining Central Hospital

    Suining

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

Other trials in China

About this study

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

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.

Read the detailed 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.

Conditions
Alopecia
Being tested
KX-826 dosed at 2.5mg, KX-826 dosed at 5 mg, Matching placebo to KX-826
Keywords
Androgenetic Alopecia, Hair loss, Female pattern hair loss
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KX-826 dosed at 2.5mgDrug

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

  • KX-826 dosed at 2.5mgDrug

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

  • KX-826 dosed at 5 mgDrug

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

  • KX-826 dosed at 5 mgDrug

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

  • Matching placebo to KX-826Drug

    Placebo applied topically to scalp once daily for 24 weeks

  • Matching placebo to KX-826Drug

    Placebo applied topically to scalp twice daily for 24 weeks

Study groups in NCT06409650
Study groupRoleWhat they receive
Arm AExperimentalKX-826 2.5mg QD
Receives: Drug: KX-826 dosed at 2.5mg
Arm BExperimentalKX-826 2.5mg BID
Receives: Drug: KX-826 dosed at 2.5mg
Arm CExperimentalKX-826 5mg QD
Receives: Drug: KX-826 dosed at 5 mg
Arm DExperimentalKX-826 5mg BID
Receives: Drug: KX-826 dosed at 5 mg
Arm EPlacebo comparatorMatching placebo QD
Receives: Drug: Matching placebo to KX-826
Arm FPlacebo comparatorMatching placebo BID
Receives: Drug: Matching placebo to KX-826

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of change in Target Area Hair Counts

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

    Measured: 24 weeks

Secondary outcomes (1)

  1. Assessment of change in Hair Growth Assessment score

    Changes from baseline in HGA (Hair Growth Assessment) score by Principal Investigator and subjects (HGA scale ranged from -3 to 3 and represented decreases from baseline that were substantial, moderate, slight, no change, slight increases, moderate increases, and substantial increases, respectively. HGA improvement was defined as a hair growth assessment score of larger than 0.)

    Measured: 6,12,18 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start9 Nov 2021
  3. Primary completion10 Nov 2022
  4. Study completion7 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06409650
Sponsor's protocol ID
KX0826-CN-1004
Status last verified
May 2024
First submitted
7 May 2024
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KX-826 dosed at 2.5mg and KX-826 dosed at 5 mg in people with Alopecia, run by Suzhou Koshine Biomedica, Inc. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of change in Target Area Hair Counts (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06409650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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