To Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males

NCT ID: NCT06692465

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2024-06-30

Brief Summary

The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.

Detailed Description

GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of androgenetic alopecia. A total of 180 adult male subjects with androgenetic alopecia (AGA) (according to Hamilton-Norwood classification IIIv, IV and V) were enrolled in this study. All subjects were randomly assigned in a 1:1:1:1:1:1ratio to investigational drug groups A, B, C and D and placebo groups E and F (i.e., 30 subjects in each group) and treated for 12 weeks at the specified dose and frequency for each group. The primary endpoint of the study is to evaluate the efficacy and safety of GT20029 solution in the treatment of androgenetic alopecia (AGA) in Chinese adult males and to determine the recommended dose for phase III trials.

Conditions

Alopecia; Male Pattern Hair Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: GT20029

Group Type: EXPERIMENTAL

GT20029 Tincture

Intervention Type: DRUG

5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Placebo Comparator: GT20029 Matching Placebo

Group Type: PLACEBO_COMPARATOR

GT20029 matching placebo

Intervention Type: DRUG

5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Interventions

GT20029 Tincture

5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Intervention Type: DRUG

GT20029 matching placebo

5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Agree to follow the trial treatment plan and visit plan, voluntarily enroll, and sign the informed consent form in writing.

2. Male, aged ≥ 18 years old, in good overall health;

3. Clinical diagnosis of androgenetic alopecia (refer to 2019 edition of Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia);

4. Alopecia severity according to Hamilton-Norwood classification IIIv, IV, V;

5. Willing to maintain the same hair style, hair color and hair length throughout the trial;

6. No parenting plan and able to use highly effective contraception during the trial and for 3 months after the last dose.

Exclusion Criteria

1. History of severe systemic diseases/surgical history, which may affect the safety and efficacy evaluation of the investigational drug, such as circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system diseases;

2. Alopecia areata or diffuse alopecia areata, syphilis alopecia, cicatricial alopecia, malnutrition, chemotherapy/radiotherapy caused by alopecia;

3. Patients with scalp skin diseases that affect the efficacy evaluation, trauma in the target area of the scalp or other scalp skin lesions requiring topical drug treatment, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy;

4. Combined with diseases that have an impact on hair growth, such as connective tissue disease, moderate to severe anemia, and significant weight loss in a short period of time;

5. Patients who have a history of hair transplantation or need to wear wig hair cover for a long time during the trial treatment;

6. Combined with endocrine related diseases affecting androgen levels, including but not limited to male testicular disease, Klinefelter syndrome, diseases affecting the hypothalamus-pituitary-gonadal axis;

7. Use of Chinese patent medicine drugs, food and health products with alopecia treatment 1 month before screening, such as Yangxue Shengfa Capsules, Lingdan Tablets, Zhangguang 101 germinal fluid, and Caifei Germinative fluid;

8. Patients who have taken androgen replacement therapy, immunosuppressive agents, corticosteroids preparations and other drugs that may interfere with the efficacy evaluation within 3 months before screening;

9. Use of minoxidil within 6 months before screening;

10. Patients treated with oral finasteride or dutasteride within 12 months before screening;

11. Patients who have used topical drugs for alopecia sites within 3 months before screening;

12. Receiving scalp radiation and/or laser or surgical therapy within 3 months before screening;

13. Use of other medical shampoos or solutions containing ketoconazole or similar ingredients (eg. Terzolin) that may interfere with the efficacy evaluation within 1 month before screening;

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

15. Abnormal and clinically significant physical examination, vital signs, 12-lead ECG, blood routine, urine routine, blood biochemistry, sex hormone tests during the screening period, and judged by the investigator to affect the efficacy and safety evaluation of subjects and test results;

16. Any or more of the results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis C virus antibody are positive;

17. Participating or participating in ongoing interventional drug or medical device clinical trials within 3 months before screening;

18. History of drug abuse within 1 year before screening;

19. Consumption of more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 3 months before screening;

20. Major surgery within 3 months before screening, or plan to undergo major surgery during the trial;

21. Other conditions that may affect compliance or unsuitable for participating in this study in the investigator 's opinion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Koshine Biomedica, Inc.

INDUSTRY

Sponsor Role: collaborator

Suzhou Kintor Pharmaceutical Inc,

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology department, Huashan Hospital, Fudan University

Shanghai, , China

Countries

China

Other Identifiers

GT20029-CN-1002

Identifier Type: -

Identifier Source: org_study_id