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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05324293
Registration number
NCT05324293
Ethics application status
Date submitted
30/03/2022
Date registered
12/04/2022
Date last updated
15/11/2023
Titles & IDs
Public title
To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
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Scientific title
An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female With Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
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Secondary ID [1]
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HMI-115102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - HMI-115
Experimental: HMI-115 240mg -
Treatment: Drugs: HMI-115
Once Every 2 weeks, subcutaneously injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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TAHC(target area hair count) of non-vellus
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Assessment method [1]
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Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.
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Timepoint [1]
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From baseline to Week 24
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Secondary outcome [1]
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TAHC of non-vellus
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Assessment method [1]
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Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
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Timepoint [1]
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From baseline to Week 6, 12, 18, and 36
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Secondary outcome [2]
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TAHW(target area hair width) of non-vellus hair
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Assessment method [2]
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Change in target area hair width (TAHW) of non-vellus hair from baseline to Week 6, 12, 18, 24, and 36 in male and female, respectively.
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Timepoint [2]
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From baseline to Week 6, 12, 18, 24, and 36
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Secondary outcome [3]
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Investigator Global Assessment (IGA)
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Assessment method [3]
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IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
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Timepoint [3]
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Week 6, 12, 18, 24, and 36
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Secondary outcome [4]
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Subject self-Assessment (SSA)
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Assessment method [4]
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SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
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Timepoint [4]
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Week 6, 12, 18, 24, and 36
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Secondary outcome [5]
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Hair growth questionnaire assessment (HGQA)
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Assessment method [5]
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HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
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Timepoint [5]
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Week 6, 12, 18, 24, and 36
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Eligibility
Key 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 and Female subjects, between 18 and 65 years of , inclusive, at the time of
signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton
scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject with clinical diagnosis of non-AGA
2. Subject with clinically relevant abnormal skin or scalp findings which could interfere
study assessment
3. Subject has used therapies associated with hair growth or may affect PRL levels,
within defined time window before Screening
4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic
dysfunction
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP ingredients
7. Any other conditions in the investigator's opinion that prevent the subject from
participating
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/09/2023
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology - Melbourne E.
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Recruitment postcode(s) [1]
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- Melbourne E.
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hope Medicine (Nanjing) Co., Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female
with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05324293
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05324293
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