A Phase 3 Randomized, Double-blind, Placebo-controlled Trial of Subcutaneous Methotrexate in Adults with Moderate to Severe Atopic Dermatitis

What this Trial Is About

Researchers are investigating the effects of methotrexate, a drug approved for conditions like arthritis and psoriasis, for adults with moderate to severe atopic dermatitis—an 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.

Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.