The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug) or an untreated area. Study participants will have treatment areas selected on the scalp to receive ALD-102 Solution (drug), placebo (saline solution) or to remain untreated. Injections will occur once every 4 weeks for a treatment period of 8 weeks.
Male or female subject aged 18 to 55 years, inclusive, at the time of informed consent.
Subject has a body mass index (BMI) between 18.0-35.0 kg/m2, inclusive, at screening.
Subject has a body weight ≥ 50 kg, inclusive, at screening.
Subject has a clinically confirmed diagnosis of AA at screening visit, based on investigator's judgement.
Very severe AA, defined by SALT score ≥ 95 at screening and/or Day 1, including alopecia universalis and alopecia totalis.
Presence of another form of alopecia (eg, androgenetic alopecia [AGA], traction and scarring alopecia, telogen effluvium).
Presence of diffuse type of AA. Note: Subjects with presence of ophiasis or siapho patterns of AA are allowed.
History or presence of hair transplants.
Sequential
ALD-102 Solution
DrugTreatment every 4 weeks for total of 8-week treatment period.
Placebo or Control
Other interventionTreatment every 4 weeks for 8-week treatment period
Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales.
AEs assessed by guidelines outlined in CTCAE at baseline, during treatment and follow-up periods. ISRs assessed by local tolerability assessments (LTA), including evaluation by the investigator of erythema, swelling, induration, and bruising, and evaluation by the subject of burning, stinging and itching. Grading using a 4-point scale of 0 to 3 (non, mild, moderate, severe) will be used to assess each sign. Pain at each treatment area will also be assessed using a pain numerical rating scale (NRS). Subjects will be asked to assign a numerical score representing the average pain intensity on a scale of 0 to 10, experienced during and after product administration. The LTA will be done during injection days and during the follow up period.
Concentration of ALD-102 in skin biopsies at Week 10 and plasma concentration of ALD-102 over time.
Skin biopsies will be collected to measure drug concentration in skin. Blood samples will be collected to measure the systemic exposure of ALD-102 in plasma.
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