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 who are at least 12 years old, with a parent or legal guardian able to sign consent forms on their behalf before the trial begins.
• People who have been diagnosed with Trisomy 21 Down Syndrome (note: translocation or mosaic Down Syndrome is listed separately as an exclusion — confirm with trial site).
• People who are able to attend scheduled visits and follow the trial's requirements.
• Females who could become pregnant must have a negative pregnancy test before starting, and must use an approved form of contraception during the trial and for at least 28 days after the last dose.
• People who have had a history of at least 6 months of either atopic dermatitis (a type of eczema) covering at least 7% of the body, or alopecia areata (a type of hair loss condition) affecting at least 25% of the scalp.
• People who are considered to be in generally good health based on a medical history review, physical examination, and blood/lab tests.

Who may not be able to join:

• People whose parent or legal guardian is unwilling or unable to give written consent or follow the study's requirements.
• People who are pregnant or breastfeeding.
• People with alopecia areata where the cause of hair loss cannot be clearly identified, or where there are other causes of hair loss present (such as hair loss from pulling, scarring, pregnancy, medications, or advanced pattern baldness).
• People with alopecia areata who have shown no signs of hair regrowth for 7 years or more since their last episode of hair loss.
• People who have an increased risk of blood clots in their veins (such as deep vein thrombosis or a clot in the lungs), or who have a close family member who had an unexplained blood clot, which may suggest an inherited clotting condition.
• People who currently have another active inflammatory skin condition (such as psoriasis, seborrheic dermatitis, or lupus) that could interfere with assessing the trial conditions.
• People who have received a live or weakened vaccine within 6 weeks before the baseline visit, or who are expected to receive one or live with someone receiving one during the trial period.
• People who have or have had a lymphoma, blood cancer, or any other cancer within the past 5 years (with limited exceptions for certain fully treated skin or cervical cancers with no spread).
• People who have a current active bacterial, viral, or parasitic infection, a history of repeated serious infections requiring antibiotics, recent skin infections requiring treatment, or a history of widespread or recurring herpes zoster or herpes simplex infections.
• People who have had alcohol or substance misuse issues within 6 months before the trial starts, which in the investigator's view would prevent them from participating.
• People who have a known or suspected problem with their immune system that leaves them with reduced immunity.
• People who have serious, progressive, or uncontrolled disease affecting the kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system, or whose blood tests show certain abnormal kidney or liver results at the screening stage.
• People who have active hepatitis B, hepatitis C, or HIV before the baseline visit.
• People who test positive or have an unclear result for tuberculosis (TB) screening, including those who have already completed TB treatment.
• People who have any other medical issues, physical exam findings, or abnormal test results that, in the investigator's opinion, could increase risk, affect the person's ability to follow the study, or affect the reliability of the results.
• People who have previously had an allergic or serious reaction to any component of the study drug, or a safety event considered related to a type of medication called a JAK inhibitor.
• People who have used certain immune-suppressing medications (including cyclosporine, steroid injections, methotrexate, oral JAK inhibitors, or UV light therapy) within 4 weeks before the baseline visit.
• People who have used certain biological treatments such as dupilumab (an injection used for eczema) within 12 weeks before the baseline visit.
• People who have used topical corticosteroids, tacrolimus, or pimecrolimus (skin creams or ointments) within 1 week before the baseline visit.
• People who have translocation or mosaic Down Syndrome.

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