Mikolow

Researchers are investigating the effects of methotrexate, a drug approved for conditions like arthritis and psoriasis, for adults with moderate to severe atopic dermatitisan ongoing skin condition causing irritation, redness, and itchiness. This phase 3 randomized, controlled clinical trial aims to evaluate the safety and effectiveness of methotrexate compared to a placebo for participants whose condition does not improve with topical treatments. The study is sponsored by medac GmbH and uses a double-blind design. Participants will receive weekly subcutaneous injections of methotrexate at 20 mg for 16 to 24 weeks, with a possible dose reduction to 15 mg if needed due to intolerance. The comparator group will receive matching placebo injections on the same schedule. The trial follows a parallel-group, randomized approach to compare these two treatment arms while monitoring their effects on atopic dermatitis. During the study, participants will be assessed regularly using various tools, including the Eczema Area and Severity Index EASI, Scoring Atopic Dermatitis SCORAD, Investigator Global Assessment IGA, Pruritus Numerical Rating Scale NRS, and quality of life measures. Safety will be monitored through adverse event tracking and laboratory tests at multiple visits through week 33. The main outcome is the proportion of participants achieving at least a 75% improvement in EASI score by week 16. Participants are expected to comply with study procedures and attend scheduled visits throughout the trial period.

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.