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To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

Primary Purpose

Alopecia, Male Pattern Hair Loss

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KX- 826 dosed at 2.5mg
KX-826 dosed at 5mg
KX-826 dosed at 5mg
Matching placebo to KX-826
Sponsored by
Suzhou Kintor Pharmaceutical Inc,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia focused on measuring Androgenetic Alopecia, Hair loss, Hair thinning, Baldness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject is capable of giving informed consent and complying with study procedures;
  2. Subject is male between the ages of 18 and 70 years, inclusive;
  3. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
  4. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
  5. Subject agrees to continue his other general hair care products and regimen for the entire study;
  6. Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and

    ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate

    ≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range values);

  7. Negative COVID-19 results within 3 days prior first dosing

Exclusion Criteria:

  1. Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;
  2. Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
  3. Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
  4. Subject had scalp hair transplants at any time
  5. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
  6. Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss;
  7. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the subject throughout the study
    • Influence the findings of the studies or their interpretations
    • Impede the subject's ability to complete the entire duration of study
  8. Subject is currently enrolled in an investigational drug or device study;
  9. Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization;
  10. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function;
  11. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits;
  12. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
  13. Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug or tattoo ink.
  14. Subject has used any of the following topical preparations or procedures on the scalp:

    • Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of randomization;
    • Use of hair regrowth products, including minoxidil, for >4 continuous weeks within 6 months before randomization;
    • Medical shampoos or solutions which include Ketoconazole or the like (e.g. Terzolin) within four weeks prior to randomization;
    • Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within four weeks of randomization;
    • Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within four weeks of randomization;
    • Scalp procedures (surgical, laser, light, or energy treatments, microneedling, etc.) within six months of randomization;
    • Platelet rich plasma (PRP) procedure on the scalp at any time point.
  15. Subject has used the following systemic medications or procedures:

    • Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of randomization. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least four weeks prior to randomization];
    • Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within six months of randomization;
    • Use of immunoglobulins/immunomodulators (eg, cyclosporin) for >4 continuous weeks within 6 months of randomization,
    • Use of 5-α-reductase inhibitors (eg, finasteride or dutasteride) and/ or antiandrogens within 12 months before randomization;
    • Use of systemic cimetidine or ketoconazole for >2 continuous weeks within 3 months before randomization;
    • Chemotherapy or cytotoxic agents within 12 months of randomization;
    • Radiation of the scalp at any time point;
    • Use of systemic corticosteroids within 2 months of randomization for >2 consecutive weeks,
    • Other systemic therapy, which in the opinion of the investigator, may materially affect the subject's hair or hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids;
  16. An unwillingness of male participants to use highly effective contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Highly effective measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation.

Sites / Locations

  • First OC Dermatology
  • Evoution Clinical Trials
  • Qway Research LLC
  • Anchor Medical Research, LLC
  • Innovation Medical Group, LLC
  • Palm Beach Research Center
  • DelRicht Research
  • ALLCUTIS Research, LLC
  • ALLCUTIS Research, LLC
  • Clinical Trials of Texas, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

KX-826: 2.5mg twice daily

KX-826: 5mg once daily

KX-826: 5mg twice daily

Matching placebo to KX-826

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of change in Hair Growth Assessment score
Changes from baseline in HGA (Hair Growth Assessment) score by Principal Investigator, subjects, and Canfield Independent panel review in comparison to placebo

Full Information

First Posted
January 30, 2022
Last Updated
September 24, 2022
Sponsor
Suzhou Kintor Pharmaceutical Inc,
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1. Study Identification

Unique Protocol Identification Number
NCT05218642
Brief Title
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
March 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Kintor Pharmaceutical Inc,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.
Detailed Description
KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Male Pattern Hair Loss
Keywords
Androgenetic Alopecia, Hair loss, Hair thinning, Baldness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
KX-826: 2.5mg twice daily
Arm Title
Arm B
Arm Type
Experimental
Arm Description
KX-826: 5mg once daily
Arm Title
Arm C
Arm Type
Experimental
Arm Description
KX-826: 5mg twice daily
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Matching placebo to KX-826
Intervention Type
Drug
Intervention Name(s)
KX- 826 dosed at 2.5mg
Intervention Description
2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
KX-826 dosed at 5mg
Intervention Description
5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
KX-826 dosed at 5mg
Intervention Description
5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Matching placebo to KX-826
Intervention Description
Placebo applied topically to scalp twice daily or once daily for 24 weeks
Primary Outcome Measure Information:
Title
Assessment of change in Target Area Hair Counts
Description
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Assessment of change in Hair Growth Assessment score
Description
Changes from baseline in HGA (Hair Growth Assessment) score by Principal Investigator, subjects, and Canfield Independent panel review in comparison to placebo
Time Frame
6,12,18 and 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is capable of giving informed consent and complying with study procedures; Subject is male between the ages of 18 and 70 years, inclusive; Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss; Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study Subject agrees to continue his other general hair care products and regimen for the entire study; Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate ≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range values); Negative COVID-19 results within 3 days prior first dosing Exclusion Criteria: Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy; Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy; Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding; Subject had scalp hair transplants at any time Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA; Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss; Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the subject throughout the study Influence the findings of the studies or their interpretations Impede the subject's ability to complete the entire duration of study Subject is currently enrolled in an investigational drug or device study; Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization; Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function; Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits; Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody; Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug or tattoo ink. Subject has used any of the following topical preparations or procedures on the scalp: Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of randomization; Use of hair regrowth products, including minoxidil, for >4 continuous weeks within 6 months before randomization; Medical shampoos or solutions which include Ketoconazole or the like (e.g. Terzolin) within four weeks prior to randomization; Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within four weeks of randomization; Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within four weeks of randomization; Scalp procedures (surgical, laser, light, or energy treatments, microneedling, etc.) within six months of randomization; Platelet rich plasma (PRP) procedure on the scalp at any time point. Subject has used the following systemic medications or procedures: Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of randomization. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least four weeks prior to randomization]; Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within six months of randomization; Use of immunoglobulins/immunomodulators (eg, cyclosporin) for >4 continuous weeks within 6 months of randomization, Use of 5-α-reductase inhibitors (eg, finasteride or dutasteride) and/ or antiandrogens within 12 months before randomization; Use of systemic cimetidine or ketoconazole for >2 continuous weeks within 3 months before randomization; Chemotherapy or cytotoxic agents within 12 months of randomization; Radiation of the scalp at any time point; Use of systemic corticosteroids within 2 months of randomization for >2 consecutive weeks, Other systemic therapy, which in the opinion of the investigator, may materially affect the subject's hair or hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids; An unwillingness of male participants to use highly effective contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Highly effective measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation.
Facility Information:
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Evoution Clinical Trials
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Qway Research LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Anchor Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Innovation Medical Group, LLC
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
DelRicht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
ALLCUTIS Research, LLC
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
ALLCUTIS Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

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