RecruitingPhase 3NCT06239311

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.


Sponsor

medac GmbH

Enrollment

277 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methotrexate and a drug called Placebo for people with moderate-to-severe atopic dermatitis. The study is currently recruiting participants at 30 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

Solution for injection in prefilled pen

DRUGPlacebo

Solution for injection in prefilled pen


Locations(30)

MU Dr. Petr Arenberger, DrSc. MBA

Prague, Praha 1, Czechia

Synexus Czech s.r.o.

Prague, Praha 2, Czechia

Praglandia s.r.o.

Prague, Praha 5, Czechia

AGE Centrum s.r.o.

Olomouc, Czechia

CCR Ostrava s.r.o,

Ostrava, Czechia

CCR Czech Pardubice a.s.

Pardubice, Czechia

Clintrial s.r.o.

Prague, Czechia

Dermatology clinic MUDr. Blanka Havlickova

Prague, Czechia

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, France

Centre Hospitalier universitaire (CHU) de Clermont Ferrand Hopital d'Estaing

Clermont-Ferrand, France

Centre Hospitalier Universitaire De Nantes

Nantes, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Ospedale San Donato di Arezzo

Arezzo, Italy

Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant' Anna

Ferrara, Italy

Ospedale Piero Palagi

Florence, Italy

Universita degli Studi della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

Naples, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Azienda Ospedaliero Universitaria Pisana (AOUP)

Pisa, Italy

Synexus Polska Sp. z o.o. in Czestochowa

Częstochowa, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, Poland

Angelius Badania Kliniczne

Katowice, Poland

Synexus Polska Sp. z. o.o. Oddzial W Lodzi

Lodz, Poland

LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska

Lublin, Poland

Klinika Zdybski

Lublin, Poland

Twoja Klinika

Mikołów, Poland

Synexus Polska Sp z o.o. Oddzial W Poznaniu

Poznan, Poland

Laser Clinic

Szczecin, Poland

Synexus Polska Sp. Z o.o. Odział w Warszawie

Warsaw, Poland

Klinika Ambroziak Dermatologia

Warsaw, Poland

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NCT06239311


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