Phase 2 Alopecia Areata Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 55 years at the time of giving consent
• People with a body mass index (a measure of body weight relative to height) between 18.0 and 35.0, and a body weight of at least 50 kg, at the screening visit
• People with a clinically confirmed diagnosis of alopecia areata (a condition causing patchy hair loss)
• People who have one or more bald patches on the scalp large enough to receive the required number of injections for their assigned group — either a patch of at least 12 cm² (about 1.86 in²) for some groups, or at least 28 cm² (about 4.34 in²) for others; if a single patch is not large enough, multiple patches may be used, each at least 2 cm²
• People who have a separate bald patch on the scalp (at least 2 cm², located at least 6 cm away from the treatment area) to serve as a comparison area
• People whose current episode of hair loss in the treatment and comparison areas has lasted more than 6 months but less than 5 years, and where the doctor assesses that hair regrowth is possible
• People who have had no noticeable hair regrowth or new hair loss in the past 6 months, as assessed by the doctor
• People willing to keep the same hairstyle and hair colouring routine for the entire duration of the trial (hair dyeing and shaving are allowed, but not within 2 weeks before a study visit)
• Women who could become pregnant must agree to use a highly effective form of contraception, plus a condom for any male partner who has not had a vasectomy, starting at least 4 weeks before the first treatment day and continuing for at least 16 weeks after the last injection, and must agree not to retrieve or donate eggs during this period (confirm details with trial site)
• Women who cannot become pregnant — either due to surgical sterilisation, or due to having had no periods for 12 or more months confirmed by a specific hormone blood test — may also be eligible (confirm with trial site)
• Men who could father a pregnancy must agree to use a condom, and their female partner must use a highly effective contraceptive method, from the first treatment day until at least 16 weeks after the last injection, and must agree not to donate sperm during this period
• Women who could become pregnant must have a negative pregnancy blood test at screening and a negative pregnancy urine test on the first treatment day
• People willing and able to give signed and dated informed consent before any study procedures begin
• People willing to follow all study procedures and remain available for the full duration of the study
• People willing to receive approximately 20 to 40 small injections into the skin every 4 weeks (the exact number depends on the assigned group)

Who may not be able to join:

• People with very severe alopecia areata, defined as a SALT score of 95 or above (meaning 95% or more of scalp hair is lost), including total scalp hair loss or total body hair loss
• People with another type of hair loss condition (such as pattern baldness, traction alopecia, scarring alopecia, or temporary shedding), unless the pattern baldness is clearly separate and does not affect the areas being studied (confirm with trial site)
• People with the diffuse type of alopecia areata (where hair loss is spread evenly across the scalp rather than in distinct patches)
• People who have had a hair transplant at any time
• People who have had scalp micropigmentation (a tattooing technique used to simulate hair); eyebrow microblading is permitted
• Women who are breastfeeding, pregnant, or planning to become pregnant during the study
• People with a known immune deficiency or a weakened immune system
• People with a history of cancer or certain blood/lymph system diseases within the past 5 years, with some exceptions for certain skin cancers or cervical carcinoma in situ that have been successfully treated (confirm with trial site)
• People who have had major surgery within 8 weeks before the first treatment day, or who have major surgery planned during the study
• People with any significant medical condition, or abnormal test results (blood tests, heart tracing, or vital signs), that the doctor considers would put them at undue risk or affect the study results
• People who test positive for hepatitis B, hepatitis C, or HIV, with some specific exceptions (confirm with trial site)
• People with a current or recent serious infection — including infections requiring hospitalisation in the past 6 months, active skin infections requiring treatment within the past 1–2 weeks, a history of widespread herpes zoster or herpes simplex, or repeated episodes of localised shingles
• People with known active tuberculosis (TB) or a positive TB test at screening, unless there is documented proof of completing a full course of treatment for latent TB with a clear chest X-ray (confirm with trial site)
• People with certain abnormal blood test results at screening, including low white blood cell counts, low red blood cell levels, low platelet counts, abnormal kidney function, or elevated liver enzymes above specified thresholds (confirm with trial site)
• People with a history of clinically significant heart disease, such as cardiomyopathy, major heart defects, a specific abnormal heart rhythm condition, heart attack, stroke, or blood clots
• People currently taking blood-thinning medications or medications known to lower platelet counts, unless it is considered safe to stop them for the duration of the study
• People with active inflammatory skin conditions on the scalp (such as psoriasis, seborrhoeic dermatitis, or lupus) that could interfere with assessing hair regrowth
• People with tattoos, open sores, scratches, or skin damage in the areas to be treated or used for comparison, if the doctor considers these would interfere with study assessments
• People currently taking, or who have taken within the past 4 weeks, any systemic (whole-body) treatment for an inflammatory condition that the doctor believes could affect safety or result assessments; common short-acting medications such as ibuprofen, paracetamol, and antihistamines are permitted
• People currently taking, or who have taken within the past 4 weeks, another non-biological experimental treatment or device
• People who have received a live or live-attenuated vaccine within 4 weeks before the first treatment day, or who plan to receive one during the study or within a specified period after the last dose
• People who have used systemic or injected-into-lesion steroids within 8 weeks before the first treatment day; nasal sprays, inhaled steroids, and eye or ear drops containing steroids are permitted
• People who have used certain systemic treatments that may affect hair regrowth (such as tacrolimus or minoxidil) within 4 weeks before the first treatment day
• People who have received UV-B light therapy, PUVA treatment, or excimer laser within 4 weeks before the first treatment day
• People who have used medicated topical treatments on the scalp (such as steroid creams, calcineurin inhibitors, minoxidil, or JAK inhibitor creams) within 2 weeks before the first treatment day; medicated topical treatments on other parts of the body are permitted
• People who have previously used a systemic JAK inhibitor medication (such as baricitinib, ritlecitinib, or deuruxolitinib) specifically for alopecia areata and stopped because it did not work; people who stopped for another reason may be eligible if they stopped at least 6 months before the first treatment day (confirm with trial site)
• People who have received platelet-rich plasma injections within 12 weeks before the first treatment day
• People who have received any approved or experimental biological medicine within 12 weeks, or 5 half-lives of that medicine (whichever is longer), before the first treatment day
• People who have received certain biological therapies that target B-cells (such as rituximab, ocrelizumab, ofatumumab, or belimumab) within 12 months before the first treatment day
• People who have ever received therapies that target a specific type of immune cell called plasmacytoid dendritic cells (confirm with trial site)
• People who have used prescription products containing androgens (such as testosterone or anabolic steroids) within the past 6 months before the first treatment day; people using over-the-counter supplements containing androgens or affecting hair growth for their alopecia areata must stop at the time of giving consent
• People with a known or suspected allergy to the study drug (ALD-102) or any of its ingredients
• People with a clinically significant history of drug or alcohol misuse in the year before the first treatment day
• People with a history of allergic reaction or significant sensitivity to lidocaine or other local anaesthetics
• People with a history of abnormal or excessive scarring (hypertrophic scars or keloids)
• People who have taken blood-thinning or antiplatelet medications (such as heparin, warfarin, or similar drugs) within 2 weeks before the first treatment day, or who have a contraindication to skin biopsies; low-dose aspirin of 81 mg or less is permitted
• People who are unable to tolerate injections into the skin, or who have a known sensitivity to needle injections
• People who are in an institution by legal or regulatory order

Important: Always verify eligibility with the trial site directly before applying.