Last reviewed · How we verify
NCT06239311
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.
Phase 3 trial testing Methotrexate in Moderate to Severe Atopic Dermatitis in 277 participants. Currently enrolling.
1 November 2026
Quick facts
| Lead sponsor | medac GmbH |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 277 |
| Start date | 27 February 2024 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 April 2027 |
| Sites | 30 locations across Czechia, France, Italy, Poland |
Drugs / interventions tested
- Methotrexate — full drug profile →
- Placebo
Conditions studied
- Moderate to Severe Atopic Dermatitis — all drugs for Moderate to Severe Atopic Dermatitis →
Sponsor
medac GmbH — full company profile →
Who can join
18 and older, any sex, with Moderate to Severe Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Eczema Area and Severity Index (EASI) 75 response at Trial Week 16 Visit
Time frame: Trial Week 16
To demonstrate the superiority of subcutaneous (SC) methotrexate (MTX) versus placebo with respect to an improvement from baseline of at least 75% of the Eczema Area and Severity Index (EASI 75 response). The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument for measuring the severity of clinical symptoms in atopic dermatitis (AD). The minimum EASI score is 0 (= normal)
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06239311
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methotrexate
Trials testing the same drug.
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07477691 — Immune Modulation During Palynziq® Treatment in Adults (IMPALA) · Phase 4 · not yet recruiting
Other recruiting trials for Moderate to Severe Atopic Dermatitis
Currently open trials in the same condition.
- NCT06723080 — Phase III Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
- NCT06468956 — Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis · Phase 3 · active not recruiting
- NCT06136741 — A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopi · Phase 2 · active not recruiting
- NCT06099704 — Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis · active not recruiting
Other medac GmbH trials
Trials by the same sponsor.
- NCT03156790 — PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia · Phase 2 · terminated
- NCT02333058 — Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies · Phase 2 · completed
- NCT00822393 — Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06239311 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by medac GmbH
- Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06239311.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing