Maldegem

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 long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Researchers are evaluating the use of therapeutic drug monitoring (TDM) to optimize dosing of biologic drugs for moderate to severe psoriasis. The study compares standard fixed dosing with dosing adjusted based on drug concentrations in the patient's blood. The goal is to maintain effective disease control while avoiding under- or overdosing, which can cause inadequate response, side effects, or increased healthcare costs. This pragmatic, multicenter, randomized Phase 4 trial is conducted in 14 Belgian hospitals with patients already receiving biologics for at least six months. Participants are randomized into two groups: one group receives dosing advice based on measured drug levels (proactive TDM), and the other continues usual care with fixed dosing. The biologics studied include secukinumab, ixekizumab, and guselkumab. Dose adjustments involve lengthening or shortening injection intervals stepwise by weeks depending on drug concentration to reach the target level. Dose reductions and escalations occur in predefined steps specific to each biologic, and adjustments continue at each study visit if targets are not met. During the 76-week study, patients have regular visits every three months to assess disease control using PASI scores and quality of life measures. Researchers track sustained disease control, treatment satisfaction, safety, and cost-effectiveness. Blood drug levels guide dose changes in the intervention group, while usual care patients maintain standard dosing schedules. The study aims to show TDM-based dosing is not inferior to standard care in maintaining disease control over 18 months, potentially improving safety and reducing costs.

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.