A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
You are being asked to take part in a research study of an investigational study drug called CTP-543. Investigational means that the study drug is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA). This is a two part research study that will evaluate the regrowth of hair of research subjects with alopecia areata (sudden hair loss) when treated with CTP-543 at two different doses twice daily for 24 weeks. The first part of the study will also evaluate what happens to hair re-growth when the dose of CTP-543 is reduced or changed to placebo (looks identical to the study drug but contains an inactive substance) after the initial 24 weeks of treatment. In the second part of the study, subjects who experienced significant hair loss following dose reduction or being changed to placebo will be re-treated with the original CTP-543 dose that they received for an additional 24 weeks to further evaluate the effects of the dose reduction or drug discontinuation (being changed to placebo) on hair re-growth. Other purposes of the study are to determine how you and the Study Doctor feel about your alopecia areata during the study. CTP-543 is a modified version of another drug called Jakafi, which is approved by the FDA for other uses, but not for alopecia areata. This study will involve approximately 300 subjects at about 25 different study sites in the United States. The study will take place for up to a maximum of 80 weeks. You will have a maximum of 16 visits to the study site in Part A, and a maximum of 9 visits to the study site in Part B. You were selected as a possible subject in this study because you have at least 50% hair loss on your head due to alopecia areata, and are between the ages of 18 and 65. You will not be able to participate if you are currently undergoing treatment with another drug or with other treatments that might affect your hair regrowth or if you are taking medications that weaken the immune system; these medications may not allow your body to protect against infection and foreign substances like bacteria and viruses. The Study Doctor can explain this to you and will make the necessary assessments and tell you if you are eligible to participate.
• Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a SALT score ≥50, at Screening and Baseline.
• Willing to comply with the study visits and requirements of the study protocol.
• Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
• Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
• Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Drug: CTP-543, Drug: Placebo