Howard County

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool SALT, eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Alopecia areata AA is a chronic autoimmune condition causing hair loss on the scalp and other body areas, affecting children, adolescents, and adults of all backgrounds. This study focuses on patients aged 12 years and older who are prescribed ritlecitinib, a medication approved for severe AA. Researchers aim to understand patient and disease characteristics, treatment patterns, and outcomes with ritlecitinib in everyday clinical practice. Participants receive ritlecitinib according to approved guidelines and their doctors judgment, reflecting real-world treatment rather than a controlled trial setting. The study observes patients over time, assessing how the medication is used and its impact on AA symptoms. No placebo or control group is involved, as the study is observational. Throughout the study, patients attend regular clinic visits to monitor their condition, complete questionnaires about their experience and quality of life, and undergo assessments like the Severity of Alopecia Tool SALT score. The main measurement is the percentage change in SALT score after 24 weeks, with additional follow-ups at later weeks to evaluate ongoing effectiveness and patient satisfaction. The total study period extends to April 2028.