Clinical trial NCT06118866: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Hope Medicine (Nanjing) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 192
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The Rate of Target Arean Hair Count (TAHC)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA)
timeFrame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
measure: Target Area Hair Count (TAHC) change from baseline
timeFrame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
measure: Rate of Target Area Hair Width (TAHW)
timeFrame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
measure: Investigator Global Assessment (IGA)
timeFrame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
measure: Subject Self-Assessment (SSA)
timeFrame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks
measure: Norwood-Hamilton Grade change from baseline
timeFrame: 12 weeks, 24 weeks, and 36 weeks
measure: Frequencies and percentages of Adverse event (AE)
timeFrame: 36Weeks
measure: Blood Pressure change from baseline
timeFrame: 36 Weeks
measure: Pulse change from baseline
timeFrame: 36 Weeks
measure: Body temperature change from baseline
timeFrame: 36 Weeks
measure: Respiratory rate
timeFrame: 36 Weeks
measure: 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.
timeFrame: 36 Weeks
measure: Concomitant Medication
timeFrame: 36 Weeks
measure: Change in twelve-lead electrocardiogram parameters
timeFrame: 36 Weeks
measure: Clinical laboratory tests of hematology
timeFrame: 36 Weeks
measure: Clinical laboratory tests of coagulation
timeFrame: 36 Weeks
measure: Clinical laboratory tests of clinical chemistry
timeFrame: 36 Weeks
measure: Clinical laboratory tests of urinalysis
timeFrame: 36 Weeks
measure: Clinical laboratory tests of hormones
timeFrame: 36 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: