NCT06239311

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

A Phase 3, Randomised, 2-arm, Parallel-group, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Subcutaneous Methotrexate Versus Placebo in Moderate to Severe Atopic Dermatitis.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (estimated)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Atopic dermatitis is an ongoing condition that causes skin irritation, redness, and itchiness. Treatments are usually topical - applied to the skin (e.g., moisturisers or medicated creams) - but a wider variety of systemic treatments (that target the whole body) are needed for those whose condition does not improve with topical treatments. Methotrexate, a drug approved for similar conditions such as arthritis and psoriasis, has been shown to improve atopic dermatitis. This randomised, controlled clinical trial will investigate how effective.

Conditions

• Moderate to Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Methotrexate	Solution for injection in prefilled pen
DRUG	Placebo	Solution for injection in prefilled pen

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-11-01
• Completion: 2027-04-01
• First posted: 2024-02-02
• Last updated: 2025-08-27

Locations

30 sites across 4 countries: Czechia, France, Italy, Poland