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A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT06118866
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Hope Medicine (Nanjing) Co., Ltd

Study Description
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Brief Summary:
To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: placebo-Q2W Drug: HMI-115-120mg-Q4W Drug: HMI-115-240mg-Q4W Drug: HMI-115, 240mg-Q2W Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy in Male Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo-Q2W
placebo, 0mg/vials
 Drug: placebo-Q2W
placebo, 0mg，SC，Q2W，12 cycles
Active Comparator: HMI-115-120mg-Q4W
HMI-115, 60mg/vials
 Drug: HMI-115-120mg-Q4W
HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
Active Comparator: HMI-115-240mg-Q4W
HMI-115, 60mg/vials
 Drug: HMI-115-240mg-Q4W
HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
Active Comparator: HMI-115-240mg-Q2W
HMI-115, 60mg/vials
 Drug: HMI-115, 240mg-Q2W
HMI-115, 240mg，SC，Q2W，12 cycles


Outcome Measures
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Primary Outcome Measures :
  1. The Rate of Target Arean Hair Count (TAHC) [ Time Frame: 24 Weeks ]
    The mean change in TAHC of non-vellus from baseline


Secondary Outcome Measures :
  1. Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA) [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks ]
    To assess the hair growth by 7-question questionnaire and summary the number and percentage of subjects in each category for each HGQA question.

  2. Target Area Hair Count (TAHC) change from baseline [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks ]
    The mean change in TAHC of non-vellus from Baseline

  3. Rate of Target Area Hair Width (TAHW) [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks ]
    The mean change in TAHW of non-vellus from baseline

  4. Investigator Global Assessment (IGA) [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks ]
    Summary of subject number and percentage in each IGA category

  5. Subject Self-Assessment (SSA) [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks ]
    Summary of subject number and percentage in each SSA category

  6. Norwood-Hamilton Grade change from baseline [ Time Frame: 12 weeks, 24 weeks, and 36 weeks ]
    Summary of subject number and percentage in each grade of Norwood-Hamilton Scale

  7. Frequencies and percentages of Adverse event (AE) [ Time Frame: 36Weeks ]
    Frequency and percentages of subjects with treatment-emergent AE (TEAE) will be calculated and TEAE will be summarized by systematic organ classification (SOC), preferred term (PT), relationship to study treatment, maximum severity, whether resulting in death, whether resulting in study treatment discontinuation, belong to serious AE (SAE) or not, belong to events of special interest (AESI) or not.

  8. Blood Pressure change from baseline [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in blood pressure (systolic and diastolic) will be compared between baseline levels and each predetermined time point.

  9. Pulse change from baseline [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in pulse will be compared between baseline levels and each predetermined time point.

  10. Body temperature change from baseline [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in body temperature will be compared between baseline levels and each predetermined time point.

  11. Respiratory rate [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in respiratory rate will be compared between baseline levels and each predetermined time point.

  12. Complete or brief physical examination, at a minimum of General appearance, HEENT (head, eyes, ears, nose, throat), Neck, Lung/pulmonary, Chest, Neurological or not, Extremities,ect.to assess the physical health state. [ Time Frame: 36 Weeks ]
    Physical examination findings by body system will be summarized, presented with frequency counts and percentages. A complete or brief physical examination will be performed at Visit 1, Visit 2, End of Treatment Visit and Follow-up Visit. Height (cm) and weight (kg) will be measured and body mass index will be calculated and recorded at specified period.

  13. Concomitant Medication [ Time Frame: 36 Weeks ]
    Concomitant medication usage will be summarized by the number and proportion of subjects and classified by the World Health Organization Drug Dictionary (WHO DD) based on Anatomical Therapeutic Chemical Classification System (ATC) code level 3.

  14. Change in twelve-lead electrocardiogram parameters [ Time Frame: 36 Weeks ]
    Change in electrocardiogram parameters including heart rate (HR), QRS, RR, PR, and QT interval (QTcF and QTcB) relative to baseline will be summarized descriptively by visits and groups. The within-group changes from baseline to each visit will be summarized and will be compared with a paired t-test for continuous measurements. Subject number and percentage with other clinically significant electrocardiogram findings in each visit will be summarized by groups. A general assessment of the 12-lead electrocardiogram will be presented as normal, abnormal clinical significance, or abnormal no clinical significance.

  15. Clinical laboratory tests of hematology [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in results of clinical laboratory tests of hematology from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.

  16. Clinical laboratory tests of coagulation [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in results of clinical laboratory tests of coagulation from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.

  17. Clinical laboratory tests of clinical chemistry [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in results of clinical laboratory tests of clinical chemistry from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.

  18. Clinical laboratory tests of urinalysis [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in results of clinical laboratory tests of urinalysis from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.

  19. Clinical laboratory tests of hormones [ Time Frame: 36 Weeks ]
    Descriptive statistics summarizing changes in results of clinical laboratory tests of hormones from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  2. Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
  3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
  4. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area.
  5. Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study.
  6. Subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of IMP or complete whole study period whichever is longer.

Exclusion Criteria:

  1. Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
  2. Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
  3. Subject with history of hair weaves within 3 months prior screening.
  4. Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
  5. Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg).

  6. Subject has any of the following conditions within 6 weeks prior to Screening:

    1. Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
    2. Heart failure with classified as being in New York Heart Association Class III or IV.
  7. Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
  8. Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
  9. Subject plans to schedule elective surgery during the study.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06118866


Contacts
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Contact: James Fan 8621-50760962 james.fan@hopemedinc.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100035
Contact: Jianzhong Zhang    8610-88325471    rmzjz@126.com   
Sponsors and Collaborators
Hope Medicine (Nanjing) Co., Ltd
More Information
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Responsible Party: Hope Medicine (Nanjing) Co., Ltd
ClinicalTrials.gov Identifier: NCT06118866    
Other Study ID Numbers: HMI-115AG201
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical