Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are studying the use of brodalumab, a biologic treatment, in patients with moderate-to-severe psoriasis. The study aims to understand how early blood levels of brodalumab and the presence of anti-drug antibodies can predict treatment response. It also seeks to define the optimal therapeutic range of brodalumab dosing to avoid over- or undertreatment, which is important because current dosing follows a fixed schedule that may not suit all patients. Participants will continue receiving brodalumab according to the standard dosing schedule a loading dose of 210 mg, followed by weekly doses of 210 mg for two weeks, then 210 mg every two weeks. During each study visit, blood samples will be taken to measure brodalumab trough levels and anti-drug antibodies. Physicians will assess psoriasis severity using the Psoriasis Severity and Area Index PASI and Investigators Global Assessment IGA scores. Patients will also complete quality-of-life questionnaires, including the Dermatology Life Quality Index DLQI and the European quality of life EQ-5D instrument. Throughout the study, participants will have regular visits to provide blood samples and complete assessments to track treatment levels, antibody presence, disease severity, and quality of life. The main outcomes include the predictive value of early drug levels and antibodies up to 24 weeks, and the development of a concentration-response curve over 52 weeks. Secondary measures include quality of life scores collected up to 52 weeks. This monitoring helps researchers understand the best dosing to improve treatment management for psoriasis patients.