Androgenetic Alopecia
Conditions
Keywords
Hair Loss, Alopecia, Autologous Cell Therapy, Hair Regeneration, Dermal Papilla Cell, Cell therapy
Brief summary
This is a Phase I/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia. In the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration. In the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.
Detailed description
Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women and is characterized by progressive hair follicle miniaturization associated with androgen sensitivity and genetic predisposition. Current treatment options for AGA are limited and may not provide sufficient therapeutic benefit for all patients. EPI-001 is an autologous dermal papilla cell therapy intended for the treatment of androgenetic alopecia. This study is designed to evaluate the safety, tolerability, and efficacy of EPI-001 in subjects with androgenetic alopecia. This study consists of two parts: a Phase I dose-escalation study and a Phase IIa dose-expansion study. In the Phase I portion, subjects will receive a single administration of EPI-001 using a traditional 3+3 dose-escalation design to evaluate dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD), and establish the recommended Phase 2 dose (RP2D). Subjects will be followed for up to 24 weeks after administration. In the Phase IIa portion, eligible subjects will be randomized in a 2:1 ratio to receive either EPI-001 at the RP2D or placebo. The study will evaluate efficacy through changes in total hair count and hair diameter, as well as investigator assessment, expert panel assessment based on clinical photographs, and subject self-assessment questionnaires. Subjects will undergo follow-up assessments for up to 48 weeks after administration.
Interventions
BIOLOGICALEPI-001
EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.
OTHERPlacebo
Placebo control administered by subcutaneous injection to the scalp.
Sponsors
Epibiotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study consists of a Phase I open-label dose-escalation portion using a traditional 3+3 design, followed by a randomized, double-blind, placebo-controlled Phase IIa dose-expansion portion with parallel assignment.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 19 years or older 2. Subjects diagnosed with androgenetic alopecia 3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period 4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period 5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation 6. Subjects who voluntarily signed written informed consent
Exclusion criteria
1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period 2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia 3. Subjects with autoimmune diseases affecting the scalp or hair 4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases 5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests 6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy 7. Subjects with hypersensitivity related to the investigational product or study procedures 8. Pregnant or breastfeeding women 9. Subjects who participated in another clinical study within the protocol-defined period 10. Subjects judged inappropriate for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose-Limiting Toxicities | Up to 4 weeks after administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events and Local Adverse Events | Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration | — |
| Number of Participants With Clinically Significant Abnormal Vital Signs | Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration | Clinically significant abnormal vital signs include abnormalities in systolic blood pressure, diastolic blood pressure, pulse rate, and body temperature. |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration | — |
| Investigator Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale | Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48 | Investigators assess hair growth improvement by comparing clinical photographs with baseline photographs using a 7-point scale ranging from -3 (greatly decreased) to +3 (greatly increased). Higher scores indicate greater improvement. |
| Subject Self-Assessment of Hair Growth Improvement Using a 7-Point Questionnaire Scale | Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48 | Participants assess overall hair growth improvement using a questionnaire evaluating whether hair became fuller, reduction in hair shedding, increase in hair thickness, improvement in hair gloss and elasticity, improvement in overall scalp appearance, and increase in hair growth rate. Each item is scored on a 7-point scale ranging from -3 (greatly worsened) to +3 (greatly improved). Higher scores indicate greater perceived improvement. |
| Change From Baseline in Total Hair Count Assessed by Phototrichogram | Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48 | Total hair count is assessed as the number of hairs identified within the target assessment area using phototrichogram imaging. Changes from baseline in total hair count within the target assessment area are evaluated. |
| Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram | Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48 | Mean hair diameter is assessed by measuring hair shaft thickness within the target assessment area using phototrichogram imaging. Changes from baseline in mean hair diameter are evaluated. |
| Expert Panel Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale | Phase IIa: Weeks 12, 24, 36, and 48 | Expert panel members assess hair growth improvement by comparing clinical photographs with baseline photographs using a 7-point scale ranging from -3 (greatly decreased) to +3 (greatly increased). Higher scores indicate greater improvement. |
Countries
South Korea
Contacts
CONTACTEpibiotech Clinical Operations
Outcome results
None listed