Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
NCT ID: NCT06239311
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
277 participants
INTERVENTIONAL
2024-02-27
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients
NCT03327116
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT06397911
Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
NCT07205081
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD
NCT04339985
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Methotrexate
Participants will receive 16 to 24 weekly subcutaneous injections of 20 mg . In case of intolerance of the 20 mg dose, a reduction to 15 mg per week is possible.
Methotrexate
Solution for injection in prefilled pen
Placebo
Participants will receive 16 to 24 weekly subcutaneous injections
Placebo
Solution for injection in prefilled pen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
Solution for injection in prefilled pen
Placebo
Solution for injection in prefilled pen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of atopic dermatitis (AD) at least 12 months prior to the Screening Visit, diagnosed as defined by the Hanifin and Rajka criteria for AD 4.
* Moderate to severe AD, defined as the following criteria at the Baseline Visit: Eczema Area and Severity Index (EASI) ≥ 16, Investigator Global Assessment (IGA) ≥ 3, Dermatology Life Quality Index (DLQI) ≥ 10
* Eligible for systemic treatment, ie, documented history (within 12 months prior to Baseline Visit) of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)s or documented systemic treatment for AD (such as cyclosporine (CYC), azathioprine and/or mycophenolate mofetil). Inadequate response to TCS or TCI is defined as failure to obtain or maintain a remission or a low activity disease (IGA ≥ 2) despite a daily treatment with a class 2 or class 3 TCS or TCI for 28 days (or the maximal authorised duration according to the Summary of Product Characteristics (SmPC))
* Treated with a stable dose of topical emollient, for at least 7 consecutive days prior to the Baseline Visit
* Chest X-ray without clinically relevant abnormalities performed within the last 6 months prior to the Baseline Visit
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* Willing and able to comply with the protocol requirements for the duration of the trial
* Covered by health care insurance in accordance with local requirements
Exclusion Criteria
* Previously treated with MTX
* Presenting a known hypersensitivity to MTX or folic acid as well as to any of the excipients
* Presenting ulcers of the oral cavity and known active gastrointestinal ulcer disease
* Presenting with known blood dyscrasia (haemoglobin \< 8.0 g/dL or white blood cell count \< 4000/mm3 or platelet count \< 100000/mm3)
* Presenting liver impairment and/or aspartate transaminase (AST) or alanine aminotransferase (ALT) \> 2 times the upper limit of normal (ULN), or bilirubin \> 5 mg/dL (85.5 μmol/L), or a positive result in the FibrotestTM at the Screening Visit
* Presenting drug or alcohol abuse within the last 12 months
* Presenting renal impairment (creatinine clearance less than 60 mL/min)
* Presenting serious, acute or chronic infections such as tuberculosis, hepatitis B or C, HIV positive, or other immunodeficiency syndromes
1. A positive test result at Screening for hepatitis B surface antigen (HBsAg) and/or core antibodies (anti-HBc) excludes the patient from trial participation. Patients with positive surface antibodies (anti-HBs) and a history of hepatitis B virus (HBV) vaccination may be included.
2. A positive test result at Screening for hepatitis C (positive hepatitis C virus (HCV) antibody test confirmed with positive hepatitis C RNA test) excludes the patient from trial participation, even if they have received appropriate and effective treatment, due to the risk of reactivation.
3. If the interferon-gamma release assay shows a positive result at the Screening Visit the patient may only be included in the trial if the tuberculosis is latent and all of the following 3 conditions are true: (i) Chest X-ray does not show evidence suggestive of active tuberculosis. (ii) There are no clinical signs and symptoms of pulmonary and/or extra-pulmonary tuberculosis. (iii) Documented receipt of one of the following prophylactic treatment regimens: Oral daily isoniazid for 6 months or Oral daily rifampin for 4 months or Isoniazid and rifapentine weekly for 3 months. The IMP can only be administered to a participant with a positive test result in the interferon-gamma release assay (or an indeterminate result if only 1 test is done, or 2 indeterminate results if a second test is done after the first indeterminate test result) after the approval of a tuberculosis specialist.
* Presenting uncontrolled infection, hospitalisation due to uncontrolled infection or treatment with intravenous antibiotics for infection within 2 months prior to the Baseline Visit
* Presenting a history of malignancy, including solid tumours and haematologic malignancies, except non-melanoma skin cancer (epithelial cell carcinoma or basal cell carcinoma) and cervical carcinoma in situ that have been treated with no evidence of recurrence during the past 5 years
* Currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD (eg. psoriasis, lupus erythematosus, eczema herpeticum)
* Treated with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the Baseline
* Treated with TCS, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the Baseline Visit
* Treated with oral corticosteroids, azathioprine, mycophenolate mofetil, CsA (Ciclosporin A) or any other systemic immunosuppressor / immunomodulator within 4 weeks before the Baseline Visit
* Treated by specific allergen immunotherapy started within 3 months before the Baseline Visit 17
* Treated with a monoclonal antibody (including but not limited to dupilumab or tralokinumab) within the last 3 months or 5 times the half-life of the respective monoclonal antibody (whichever is the longer period) or with any JAK (Janus kinase) inhibitors (including but not limited to ruxolitinib, baricitinib, tofacitinib, upadicitinib, or abrocitinib) within the last 4 weeks prior to the Baseline Visit
* Treated with any parenteral corticosteroid within 6 weeks prior to the Baseline Visit
* Treated with ultraviolet therapy within 4 weeks prior to the Baseline Visit
* Received a live (attenuated) vaccine within 4 weeks before the Baseline Visit or planning to be vaccinated with live vaccine during the trial. Please note: Since MTX may have an effect on the immune system, vaccination with live vaccines must not be performed during MTX administration
* Having a planned surgery during the trial
* Presenting a clinically significant medical disease that is uncontrolled despite treatment that, in the opinion of the Investigator, is likely to impact the ability to participate in the trial or to impact the trial efficacy or safety assessments
* Presenting any additional condition that, in the opinion of the Investigator, may interfere with the assessment or may put the participant at risk
* Protected by the law (adult under guardianship, or hospitalised in a public or private institution for a reason other than this trial, or incarcerated)
* Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
medac GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey Nosbaum, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Université Lyon 1 / INSERM U1111 - CIRI / Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-504443-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
MC-MTX.18/AD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.