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Are you experiencing hair loss due to alopecia areata, a condition where hair loss results from the immune system (pathologic T cells) attacking the hair follicle? We are recruiting eligible participants for a new study investigating rezpegaldesleukin (REZPEG for short), a targeted therapy that may help reverse hair loss in patients with alopecia areata (AA).

We are currently recruiting adult males ages 18 to 60 and adult females ages 18 to 70 with hair loss (severe to very severe) due to alopecia areata (AA) to participate in a clinical trial. The main purpose of this study is to evaluate how safe and effective the investigational drug Rezpegaldesleukin (REZPEG) is in participants experiencing hair loss from AA.

The study consists of a subcutaneous injection (an injection placed in the fatty tissue, just under the skin) given every 2 weeks at the clinic. Different doses of REZPEG will be compared to placebo. This is a randomized, double-blind study. Randomized means that whether you receive REZPEG or placebo will be decided by chance, by a computer. Before you start the treatment period, you will be randomly assigned (like flipping a coin) by a computer to 1 of 3 groups.  Participants will be asked to complete questionnaires about their health throughout the study. Study treatment will be administered by the study staff. 

Participation will last approximately 65 weeks, including up to 35 days for screening, 36 weeks of treatment, and 24 weeks of follow up. Visits take approximately 30 minutes to 2.5 hours each, except for the first visit (screening) which may take up to 3 hours. 

Blood samples will be collected from all participants.

An electrocardiogram to check heart health will be taken at the beginning and end of the study.

Medical photography of the scalp (and where applicable of the eyelashes, eyebrows, an/or beard) will be taken for hair growth evaluation.

Compensation for time and travel may be available. There will be no cost to you for being considered or for taking part in this study, and you will be provided with all study medication, examinations, and medical care related to the study.

To see if you may be eligible to participate in the study, please complete the online study-specific questionnaire.


Visits
Drug administered on which days
Total
Length
Procedures
Study Length
Days
Screening, Day 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, 253, 281, 309, 365, 421
Total
24
Length
Up to 3 hours
Procedures
Blood samples, Electrocardiogram, urinalysis, full face medical photography
Study Length
approximately 65 weeks
Summary
We are currently recruiting adult males ages 18 to 60 and adult females ages 18 to 70 with hair loss (severe to very severe) due to alopecia areata (AA) to participate in a clinical trial. The main purpose of this study is to evaluate how safe and effective the investigational drug Rezpegaldesleukin (REZPEG) is in participants experiencing hair loss from AA. Please note that other forms of alopecia, such as traction alopecia or androgenic alopecia (pattern hair loss), would not be eligible.
Condition
Alopecia areata
Treatment
Rezpegaldesleukin
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