Howard County

Researchers are studying the long-term safety and effects of the medicine ritlecitinib for children with severe alopecia areata, a condition causing significant hair loss. This Phase 3 extension study involves participants who completed previous ritlecitinib studies and aims to assess long-term safety, effectiveness, and patient quality of life over up to 3 years. The study focuses on children aged 6 to 14 years who have experienced severe hair loss and have met specific prior study criteria. All participants receive ritlecitinib capsules taken once daily at home. Those who had higher or lower doses in a previous study continue the same dose, while those who previously received placebo or came from a different parent study are randomly assigned to a higher or lower dose. The study lasts up to 3 years and includes 17 clinic visits plus monthly phone calls to monitor treatment and health. During the study, participants are regularly evaluated for safety and treatment response using hair loss assessments and patient-reported measures of anxiety, depression, behavior, and skin-related quality of life. Safety monitoring tracks side effects and serious events from the start of consent through at least 28 days after the last dose. Participants are checked multiple times to decide whether to continue treatment, ensuring close observation throughout the trial.

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years. Alopecia areata is a condition that causes significant hair loss. This study aims to compare how well ritlecitinib works for hair regrowth compared to a placebo, along with assessing its safety and impact on patient quality of life. The study includes three groups: one receiving a higher dose of ritlecitinib, one receiving a lower dose, and one receiving a placebo. All treatments are given as oral capsules taken once daily at home for 24 weeks. Participants eligible for the study have at least 50% scalp hair loss and specific vaccination or virus exposure history. After the 24-week treatment, participants may join a long-term extension study or complete a 4-week follow-up if not eligible. Participants will attend 8 clinic visits during the 6-month study and receive about 8 phone calls for monitoring. Assessments include measuring scalp hair loss using the Severity of Alopecia Tool (SALT), evaluations of eyebrows and eyelashes, patient-reported outcomes on anxiety, depression, and quality of life, and pharmacokinetic sampling. Safety monitoring is ongoing to watch for potential risks associated with ritlecitinib.

Alopecia areata (AA) is a long-lasting autoimmune condition that causes nonscarring hair loss affecting people of all ages, races, and genders. It mainly impacts the scalp but can also involve nails, eyelashes, eyebrows, and other hair areas on the body. The three main types of AA are patchy alopecia, alopecia totalis, and alopecia universalis. Ritlecitinib is a recently approved medication targeting specific enzymes involved in AA, and this study aims to assess its effectiveness and patient outcomes in a real-world setting. Patients in this study will receive ritlecitinib as prescribed by their doctors according to the approved product label and standard care practices. Treatment will be given in routine clinical practice without influence from the study. The study does not include a comparison group but will monitor how patients are treated with ritlecitinib and their response over time. Participants will have regular clinic visits as part of their standard care, during which data on their disease and treatment will be collected. This includes patient-reported outcomes and questionnaires. The main outcome measured is the percentage change in hair loss severity using the Severity of Alopecia Tool (SALT) score after 24 weeks of treatment. The study will help provide insights into patient characteristics, treatment patterns, and clinical results with ritlecitinib in everyday medical practice.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.