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.
• People who are willing and able to attend scheduled study visits and follow the study requirements.
• People who report having moderate-to-severe scarring hair loss (specifically FFA or CCCA) for at least 6 months, confirmed by clinical assessment using specific scoring tools.
• People who have tested negative for tuberculosis (TB) — either through a skin test or a blood test — at screening or within the past 12 months.
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or, if they can become pregnant and are sexually active, are using a highly effective form of contraception (with a failure rate of less than 1%) during the study and for at least 28 days after the last dose; women who can become pregnant must also have a negative pregnancy test at screening and again before the first dose.
• People who are considered to be in generally good health overall, based on medical history, physical examination, and laboratory tests.

Who may not be able to join:

• People whose cause of hair loss cannot be clearly identified, or who have multiple causes of hair loss such as pregnancy-related hair loss, medication-related hair loss, a condition called telogen effluvium, or advanced pattern baldness.
• People who have had scarring hair loss for more than 5 years since it first started, have severe scarring skin disease, or are experiencing very rapid hair loss at the time of screening.
• People who have a history of moderate to severe raised scar tissue (keloids) on the scalp, as identified by clinical examination at screening.
• People with other scalp conditions that could interfere with assessments, such as scalp psoriasis or dermatitis.
• People who are currently pregnant or breastfeeding.
• People who have taken part in another study involving an experimental drug within the past 4 weeks or within 5 half-lives of that drug (whichever is longer), or who plan to do so during the study (applies to new patients only).
• People with active conditions affecting the whole body that are known to cause hair loss, such as lupus, thyroid inflammation, or systemic sclerosis.
• People with a psychiatric condition that the investigator determines would prevent safe participation in the study.
• People with a current or recent history of serious, progressive, or poorly controlled disease 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 that could increase the risks of the study or affect the results.
• People with a history of blood clots in the veins or lungs (such as DVT or PE), or inherited blood clotting disorders.
• People with current or past cancers, except for certain types of skin cancer or cervical changes that have been fully treated or removed and have not spread.
• People with a history of lymphoma, leukaemia, or other disorders of the lymph system, including those related to the Epstein-Barr virus, or who currently show signs of such conditions.
• People with a history of widespread (disseminated) herpes zoster or herpes simplex infection, or more than one episode of localised shingles.
• People who have had a serious infection requiring hospitalisation or intravenous antibiotics within the 6 months before the study start date.
• People who are currently being treated with oral antibiotics, antivirals, or antifungal medications within 4 weeks before the study start date, or who have had a skin infection within 1 week before the study start date.
• People who are considered to need urgent surgery, or who have elective surgery planned during the study period.
• People with active hepatitis B, hepatitis C, or HIV infection, or a positive HIV test at screening.
• People with laboratory test results that are unclear or significantly abnormal in a way that could affect the study results, as determined by the principal investigator.
• People with a history of alcohol or substance misuse within the past year before the study start date.
• People who have received a live attenuated vaccine (a type of vaccine made from a weakened live virus) within 6 weeks before screening.
• People with a known history of serious allergic or adverse reactions to any components of the study drug.
• People who have used systemic (whole-body) immune-suppressing medications — such as cyclosporine, oral corticosteroids, mycophenolate mofetil, azathioprine, or methotrexate — within 8 weeks before the baseline visit.
• People who have used certain non-biologic systemic treatments for scarring hair loss — including 5α-reductase inhibitors, hydroxychloroquine, or retinoids — within 4 weeks before the baseline visit.
• 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 baseline visit.
• People who have ever previously used a TYK2 inhibitor medication (the class of drug being studied in this trial).
• People who have used topical corticosteroids, tacrolimus, pimecrolimus, or topical cyclosporine within 1 week before the baseline visit.
• People who have been treated with biological drugs for any condition within the past 12 weeks.
• People who have previously had a positive or unclear TB test result, including those who completed TB treatment.

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