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:

• Adults aged 18 or older at the time of signing up for the study, of any gender.
• People who are willing and able to attend scheduled study visits and follow the study's requirements.
• People who report having had a type of scarring hair loss (specifically lichen planopilaris or central centrifugal cicatricial alopecia) for at least 6 months, confirmed by a doctor's examination or tissue sample analysis.
• Women who could become pregnant must have had a negative pregnancy test at the start of the study and must have been using an accepted form of birth control for at least 30 days before starting and for at least 28 days after the last dose of the study drug — accepted methods include an IUD, hormonal contraceptives (pill, patch, implant, or injection started at least one month before joining), tubal ligation, abstinence, or barrier methods with spermicide.
• Women who cannot become pregnant must have a sterile or vasectomised partner, have had a hysterectomy or removal of both ovaries, be diagnosed as infertile, or have been in menopause for at least one year.
• People who are generally in good overall health, as determined by a full medical history, physical examination, and lab tests.

Who may not be able to join:

• People whose hair loss cannot be clearly identified as scarring hair loss, or who have additional causes of hair loss such as pregnancy-related hair loss, medication-related hair loss, telogen effluvium, or advanced pattern baldness.
• People who have had scarring hair loss for 4 years or more since it first started, who have severe scarring of the skin, or who are experiencing very rapid hair loss at the time of screening.
• People with a history of moderate to severe raised scar tissue (keloids) on the scalp, as assessed during the screening examination.
• People with other scalp conditions that could affect study assessments, such as scalp psoriasis or dermatitis.
• People who are pregnant or breastfeeding.
• People who have taken part in another clinical trial involving an experimental drug within the 4 weeks before joining (or within 5 half-lives of that drug, whichever is longer), or who plan to do so during the study (for new patients only).
• People with active whole-body conditions that can cause hair loss, such as lupus, thyroid inflammation, or systemic sclerosis.
• People with a psychiatric condition that the study doctor believes would prevent safe participation.
• People with a current or recent history of serious, progressive, or uncontrolled conditions affecting the kidneys, liver, blood, digestive system, metabolism, hormones (particularly thyroid disease), lungs, heart, immune system, or nervous system — or any other serious medical or psychiatric condition or abnormal lab result that could affect safety or interfere with study results, or that the study doctor considers makes participation inappropriate.
• People with a history of blood clots in the veins (such as deep vein thrombosis or pulmonary embolism) or inherited blood clotting disorders.
• People with a current cancer or a history of cancer, except for certain skin cancers or cervical changes in situ that have been adequately treated or removed.
• People with a history of lymphoma, leukaemia, Epstein-Barr virus-related lymph disorders, or current signs or symptoms suggesting a lymph-related condition.
• People who have had a serious infection requiring hospitalisation or intravenous antibiotics within 6 months before the study start date.
• People currently being treated with oral antibiotics, antivirals, or antifungal medications within 4 weeks before the study start date, or with a superficial skin infection within 1 week before the start.
• People who are expected to need surgery soon or have elective surgery planned during the study period.
• People with a history of alcohol or substance misuse within the past year.
• People with unexplained or significant abnormal laboratory results that could affect how study data is interpreted, as determined by the lead study doctor.
• People who have had a serious allergic or adverse reaction to any component of the study drug.
• People who have used immune-suppressing medications (such as cyclosporine, systemic corticosteroids, mycophenolate mofetil, azathioprine, or methotrexate) within 8 weeks before the study start.
• People who have used certain other non-biological treatments for scarring hair loss — including 5α-reductase inhibitors, hydroxychloroquine, or retinoids — within 4 weeks before the study start.
• People who have used steroid injections into the scalp or oral JAK inhibitor medications (such as tofacitinib, ruxolitinib, or similar drugs) within 4 weeks before the study start.
• People who have used topical corticosteroids, tacrolimus, pimecrolimus, or topical cyclosporine within 1 week before the study start.
• People who have been treated with biological drugs for any condition within the past 12 weeks.

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