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:

For people with APECED-related hair loss (alopecia areata):

• The person must be able to understand the study and give their agreement to take part.
• The person must be aged between 12 and 75 years old.
• The person must have a diagnosis of APECED (confirmed by genetic testing or clinical diagnosis) and severe alopecia areata, meaning at least 50% of scalp hair has been lost as measured by a standard scoring tool.
• The hair loss must have been present for more than 6 months.
• There must be no signs of hair currently growing back.
• The person must either have never received treatment for alopecia areata, or previous treatments must not have worked.
• The person must not have received any alopecia treatment in the 2 months before joining the study.
• The person must be willing to take a medication called valacyclovir to help prevent herpes virus reactivation during the study.
• Vaccinations must be up to date in line with current CDC guidelines before starting the study medication.
• The person must be able to read and write in English.
• People who could become pregnant or could make a partner pregnant must agree to use at least one highly effective form of contraception during any sexual activity that could result in pregnancy, from the screening visit until 12 weeks after the last dose. Accepted methods include: hormonal contraception (such as the pill, patch, vaginal ring, injection, or implant) used stably for at least one month before screening; an intrauterine device (IUD) or hormonal IUD; two barrier methods used together (such as a condom plus spermicide, or a diaphragm or cervical cap with spermicide — note that two condoms used together are not acceptable); or permanent surgical sterilisation of the fallopian tubes. Methods such as tracking fertility cycles, withdrawal, spermicide alone, or breastfeeding as contraception are not accepted.

For family members or people living in the same household as a participant:

• The person must be aged 18 years or older.
• The person must live in the same home as a study participant.
• The person must be able to read and write in English.

Who may not be able to join:

For people with APECED-related hair loss (alopecia areata):

• People who have had an allergic reaction to ruxolitinib or similar medications (called JAK inhibitors).
• People who have, or have had, another skin condition affecting the scalp, such as psoriasis or seborrheic dermatitis.
• People whose hair loss diagnosis is uncertain, or where the pattern of hair loss makes it difficult to measure accurately — for example, people with a different type of hair loss related to hormones (androgenic alopecia).
• People who have used certain hair or scalp treatments in the past 2 months, including steroid injections into the scalp, oral or systemic steroids, or other medications the study doctor considers may affect hair regrowth.
• People who have used an experimental drug within the past 3 months, or within 5 half-lives of that drug — whichever is the longer period.
• People who are already enrolled in, or plan to join, another clinical study using an experimental drug during this study.
• People who have used medications that suppress or modify the immune system within the past 3 months, with an exception for low-dose steroid use (up to the equivalent of 10 mg of prednisone per day).
• People currently taking steroids at a daily dose above the equivalent of 10 mg of prednisone, or who have taken a high "burst" dose of steroids for more than 3 days within the past month.
• People with a history of alcohol or drug misuse within the past 6 months.
• People with certain significant abnormalities shown in blood tests, including problems with liver function, blood cell counts, kidney function, or other related markers (confirm specific thresholds with trial site).
• People who have a major surgical procedure planned during the study period.
• People who plan to receive a live vaccine within one month of starting the study medication.
• People who have an immune deficiency condition other than APECED.
• People with a history of serious infections that were never treated, or who have a pattern of unusually frequent or prolonged infections suggesting a weakened immune system.
• People with untreated latent (inactive) tuberculosis.
• People living with HIV.
• People with untreated hepatitis B or C infection.
• People who have had a serious bacterial infection in the past 3 months, unless it was fully treated and resolved with antibiotics; or people with any ongoing long-term bacterial infection.
• People with a history of blood clots in the veins or arteries, including deep vein thrombosis (DVT), pulmonary embolism, or other clotting events that occurred without a clear cause.
• People with a history of stroke, heart attack, or heart failure.
• People who had a herpes zoster (shingles) or cytomegalovirus infection that cleared up within the 2 months before the screening visit.
• People with a history of certain skin cancers (basal cell carcinoma, localised squamous cell carcinoma, or cervical carcinoma in situ), unless treatment was completed at least 12 months ago and the person is in remission.
• People with a history of any other cancer, unless treatment was completed at least 5 years ago and the person is in remission.
• People who plan to use any medications or procedures that are prohibited under the study rules.
• People who are currently pregnant or breastfeeding.
• People who have other medical issues, abnormal physical examination results, abnormal ECG (heart trace) findings, or abnormal test results that, in the study doctor's judgement, could pose risks or interfere with the study.

For family members or household contacts: There are no exclusion criteria listed for this group.

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