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

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

Tracking Information

• First Submitted Date: October 16, 2023
• First Posted Date: November 7, 2023
• Last Update Posted Date: April 29, 2024
• Actual Study Start Date: September 11, 2023
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2023)

The Rate of Target Arean Hair Count (TAHC) [ Time Frame: 24 Weeks ]

The mean change in TAHC of non-vellus from baseline

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia
• 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
• Brief Summary: To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia

Intervention

• Drug: placebo-Q2W
  placebo, 0mg，SC，Q2W，12 cycles
• Drug: HMI-115-120mg-Q4W
  HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
• Drug: HMI-115-240mg-Q4W
  HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
• Drug: HMI-115, 240mg-Q2W
  HMI-115, 240mg，SC，Q2W，12 cycles

Study Arms

• Placebo Comparator: placebo-Q2W
  placebo, 0mg/vials
  Intervention: Drug: placebo-Q2W
• Active Comparator: HMI-115-120mg-Q4W
  HMI-115, 60mg/vials
  Intervention: Drug: HMI-115-120mg-Q4W
• Active Comparator: HMI-115-240mg-Q4W
  HMI-115, 60mg/vials
  Intervention: Drug: HMI-115-240mg-Q4W
• Active Comparator: HMI-115-240mg-Q2W
  HMI-115, 60mg/vials
  Intervention: Drug: HMI-115, 240mg-Q2W

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 3, 2023): 180
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06118866
• Other Study ID Numbers: HMI-115AG201
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hope Medicine (Nanjing) Co., Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Hope Medicine (Nanjing) Co., Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hope Medicine (Nanjing) Co., Ltd
• Verification Date: October 2023