Torhout

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 studying patients with moderate-to-severe psoriasis to evaluate the effectiveness of monitoring early serum trough levels and anti-drug antibodies of brodalumab. The goal is to understand the predictive value of these early measurements and to determine the optimal therapeutic window for brodalumab treatment. Biologics like brodalumab are currently the most effective treatment but can be costly and are often prescribed using a uniform dosing approach, which may lead to over- or undertreatment. Participants will receive brodalumab following the standard dosing schedule: a loading dose of 210 mg, once a week for two weeks at 210 mg, followed by maintenance doses of 210 mg every two weeks. During study visits, blood samples will be collected to measure brodalumab serum trough levels and anti-drug antibodies. The severity of psoriasis will be assessed using the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA). Participants will also complete quality of life questionnaires including the Dermatology Life Quality Index (DLQI) and the EQ-5D. Throughout the study, blood tests and clinical assessments will track how patients respond to treatment over time. Researchers will analyze the relationship between drug levels, antibody development, and disease severity to better understand brodalumab's concentration-response curve. This monitoring will happen at each visit from the start of treatment through 24 to 52 weeks. The study helps to identify safe and effective dosing for psoriasis patients while considering quality of life and treatment outcomes.