Moderate to Severe Atopic DermatitisPhase 3NCT06239311
Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
A Phase 3 study testing Methotrexate in people with Moderate to Severe Atopic Dermatitis, run by medac GmbH at 30 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 27 Feb 2024to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman of childbearing potential must have a negative pregnancy test at the Screening Visit and must agree to use highly effective methods of contraception while taking the investigational medicinal product (IMP) and for 6 months after the last IMP administration. Men must agree to use a condom during intercourse while taking the IMP and for 3 months after the last IMP administration. They must also agree to not donate sperm for the time period starting at the Screening Visit, throughout the entire trial period, and for at least 3 months after the last IMP administration.
- 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
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- 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
Who cannot join
- Pregnant or breast-feeding women, or planning to become pregnant, or to breastfeed during the trial
- 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
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- 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
- 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.
- 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.
- 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
Trial locations and contacts
30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 4 countries
Poland12 sites, 11 recruiting
- Recruiting
Synexus Polska Sp. z o.o. in Czestochowa
Częstochowa, 42-202
Anna Janowicz, +48343904451, Anna.Janowicz@globalaes.com
- Recruiting
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382
Joanna Renczynska-Matysko, +48587129970, joanna.renczynska-matysko@globalaes.com
- Recruiting
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
Marcin Zakrzewski, +48322021414, Marcin.Zakrzewski@globalaes.com
- Recruiting
Angelius Badania Kliniczne
Katowice, 40-611
Anita Lewartowska-Białek, +48608070581, a.bialek@angelius.org
- Recruiting
Synexus Polska Sp. z. o.o. Oddzial W Lodzi
Lodz, 90-127
Joanna Sieniawska, +48422986506, joanna.sieniawska@globalaes.com
- Recruiting
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin, 20-573
Dorota Krasowska, +48 608 098 578, dor.krasowska@gmail.com
- Recruiting
Klinika Zdybski
Lublin, 20-607
Joanna Nowak, +48602343057, joanna.nowak@zdybski.pl
- Recruiting
Twoja Klinika
Mikołów, 43-190
Santa Vanaga-Besser, +48695479013, s.vanaga-besser@twoja-klinika.pl
- Recruiting
Synexus Polska Sp z o.o. Oddzial W Poznaniu
Poznan, 60-702
Grazyna Wolnik-Trzeciak, +48618802420, grazyna.wolnik-trzeciak@globalaes.com
- Recruiting
Laser Clinic
Szczecin, 70-332
Katarzyna Turek-Urasinska, +48914338618, katarzyna.urasinska@wp.pl
- Recruiting
Synexus Polska Sp. Z o.o. Odział w Warszawie
Warsaw, 02-672
Ryszard Galus, +48226444161, ryszard.galus@globalaes.com
- Withdrawn
Klinika Ambroziak Dermatologia
Warsaw, 02-953
Czechia8 sites, 6 recruiting
- Withdrawn
AGE Centrum s.r.o.
Olomouc, 77900
- Recruiting
CCR Ostrava s.r.o,
Ostrava, 702 00
Sylva Zajícova, +420 555 508 684, sylva.zajicova@ccrostrava.com
- Recruiting
CCR Czech Pardubice a.s.
Pardubice, 53000
Andrea Bartlova, andrea.bartlova@pratia.com
- Recruiting
MU Dr. Petr Arenberger, DrSc. MBA
Prague, Praha 1, 11000
Petr Arenberger, +420 224 232 468, avemedica@email.cz
- Terminated
Synexus Czech s.r.o.
Prague, Praha 2, 12000
- Recruiting
Praglandia s.r.o.
Prague, Praha 5, 15000
Andrea Vocilkova, +420 608 052 214, a.voc@praglandia.cz
- Recruiting
Clintrial s.r.o.
Prague, 10000
Otakar Komarek, + 420 222510607, o.komarek@clintrial.cz
- Recruiting
Dermatology clinic MUDr. Blanka Havlickova
Prague, 11000
Blanka Havlickova, +420 606072078, maposta@email.cz
Italy6 sites, 2 recruiting
- Recruiting
Ospedale San Donato di Arezzo
Arezzo, 52100
Aldo Cuccia, +39 3288756672, aldo.cuccia@uslsudest.toscana.it
- Withdrawn
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant' Anna
Ferrara, 44124
- Withdrawn
Ospedale Piero Palagi
Florence, 50125
- Withdrawn
Universita degli Studi della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
Naples, 80138
- Withdrawn
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
- Recruiting
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, 56126
Marco Romanelli, +39 050 992436, marco.romanelli@unipi.it
France4 sites, 1 recruiting
- Withdrawn
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, 33075
- Withdrawn
Centre Hospitalier universitaire (CHU) de Clermont Ferrand Hopital d'Estaing
Clermont-Ferrand, 63003
- Withdrawn
Centre Hospitalier Universitaire De Nantes
Nantes, 44093
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Audrey Nosbaum, +33 4 18 86 15 72, audrey.nosbaum@chu-lyon.fr
About this study
Official title: 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.
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
- Being tested
- Methotrexate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Solution for injection in prefilled pen
PlaceboDrug
Solution for injection in prefilled pen
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | 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. Receives: Drug: Methotrexate |
| Placebo | Placebo comparator | Participants will receive 16 to 24 weekly subcutaneous injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) 75 response at Trial Week 16 Visit
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) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 16
Secondary outcomes (22)
Improvement from baseline of at least 50% in the Eczema Area and Severity Index (EASI 50 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) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Improvement from baseline of at least 75% in 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 AD. The minimum EASI score is 0 (= normal) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 24
Improvement from baseline of at least 90% in the Eczema Area and Severity Index (EASI 90 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) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in the Eczema Area and Severity Index (EASI) score.
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) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Scoring Atopic Dermatitis (SCORAD) 50 response
Response is defined as an improvement from baseline of at least 50%.
The Scoring Atopic Dermatitis (SCORAD) evaluates the extent and severity of eczema in atopic dermatitis (AD) based on affected body area and intensity of plaque characteristics.It comprises 3 areas: Area, Intensity and Subjective Symptoms. The final result range is between 0 (best result) and 103 (worst result).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Scoring Atopic Dermatitis (SCORAD) 75 response
Response is defined as an improvement from baseline of at least 75%.
The Scoring Atopic Dermatitis (SCORAD) evaluates the extent and severity of eczema in atopic dermatitis (AD) based on affected body area and intensity of plaque characteristics.It comprises 3 areas: Area, Intensity and Subjective Symptoms. The final result range is between 0 (best result) and 103 (worst result).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16,
Change in Scoring Atopic Dermatitis (SCORAD) score from baseline
The Scoring Atopic Dermatitis (SCORAD) evaluates the extent and severity of eczema in atopic dermatitis (AD) based on affected body area and intensity of plaque characteristics.It comprises 3 areas: Area, Intensity and Subjective Symptoms. The final result range is between 0 (best result) and 103 (worst result).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Investigator Global Assessment (IGA) response
Investigator Global Assessment (IGA) response is defined as either an IGA score of 0 (clear) or 1 (almost clear) and a reduction of the score of at least 2 points.
The IGA score is a 5-point scale with morphologic descriptors for each score to assess the severity of atopic dermatitis from 0 - Clear 4 - Severe.
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16, Trial Week 24
Pruritus Numerical Rating Scale (NRS) response
The Pruritus Numerical Rating Scale (NRS) response is defined as a decrease of the worst daily Pruritus NRS score from baseline by at least 4 points in participants with an NRS of at least 4 points at baseline.
The NRS is a single item designed to capture information on self-reported severity of worst itching each day on an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable").
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16, Trial Week 24
Change from baseline in Pruritus Numerical Rating Scale (NRS) score
The Pruritus Numerical Rating Scale (NRS) is a single item designed to capture information on self-reported severity of worst itching each day on an 11-point scale from 0 (no itch) to 10 (worst itch imaginable).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Patient-oriented Eczema Measure (POEM) response
Patient-oriented Eczema Measure (POEM) response is defined as reduction from baseline of at least 4 points.
The POEM is a seven-item, patient-reported questionnaire assessing atopic dermatitis (AD)/eczema-specific symptoms over the last week; each item is scored 0 (no days) to 4 (every day) based on the number of days affected. The minimum POEM score is 0 (best result) and the maximum total POEM score is 28 (worst result).
Measured: Trial Week 8, Trial Week 16
Change from baseline in POEM score
The POEM is a seven-item, patient-reported questionnaire assessing atopic dermatitis (AD)/eczema-specific symptoms over the last week; each item is scored 0 (no days) to 4 (every day) based on the number of days affected. The minimum POEM score is 0 (best result) and the maximum total POEM score is 28 (worst result).
Measured: Trial Week 8, Trial Week 16
Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) and serious adverse reactions (SARs)
For participants who have not reached EASI 50 by the Trial Week 16 Visit and do not enter the extension phase: Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) occurring from the Screening Visit until Trial Week 16 Visit, and serious adverse reactions (SARs) occurring from start of the trial intervention until the Trial Week 20 Visit For participants who do reach EASI 50 by the Trial Week 16 Visit and do enter the extension phase: AEs, treatment-related AEs, SAEs occurring from the Screening Visit until End of Extension Visit (Trial Week 24), and SARs occurring from start of the trial intervention until the Follow-up Visit (Trial Week 33)
Measured: Trial Week 16, Trial Week 20, Trial Week 24, Trial Week 33
Dermatology Life Quality Index (DLQI) response
Dermatology Life Quality Index (DLQI) response is defined as reduction of at least 4 points in DLQI from baseline.
The DLQI is a 10-item questionnaire assessing health-related quality of life over the last week in patients with dermatological symptoms, with each item scored for impact from not at all (0) to very much (3).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Dermatology Life Quality Index (DLQI) score.
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire assessing health-related quality of life over the last week in patients with dermatological symptoms, with each item scored for impact from not at all (0) to very much (3).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Scoring Atopic Dermatitis (SCORAD) sleep score
Scoring Atopic Dermatitis (SCORAD) sleep score is a subset of the SCORAD related to the subjective symptoms section (insomnia) sleeplessness will be evaluated by the participant (based on the quality of life in the past 3 days). A 10 cm visual analogue scale is used, with 0 for no symptom and 10 for most severe symptom.
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Work Productivity and Activity Impairment: General Health (WPAI:GH)
The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire consists of 6 questions assessing the effect of AD (including physical and emotional problems or symptoms) on the participant's ability to work and to perform regular activities. The questions are computed according to specific calculation rules and have four scores. High scores indicate prolonged sick leave or impairment and decreased productivity.
Measured: Trial Week 8, Trial Week 16
Change from baseline in Hospital Anxiety and Depression (HADS) score and subscales
Hospital Anxiety and Depression (HADS) is a fourteen-item scale with seven items each for anxiety and depression subscales. Each subscale can score between 0 (best result) and 21 (worst result) for either anxiety or depression.
Measured: Trial Week 8, Trial Week 16
Change from baseline in European Quality of Life (EuroQoL) Group 5 Dimension 5 Levels (EQ-5D-5L)
The European Quality of Life (EuroQoL) Group 5 Dimension 5 Levels (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises 5 dimensions, each dimension has 5 levels. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number ranging from 11111 (full health) to 55555 (worst health).
The EQ VAS records the participant's self-rated health on a vertical visual analogue scale from 0 (The worst health you can imagine) to 100 (The best health you can imagine).
Measured: Trial Week 8, Trial Week 16
Change from baseline in Atopic Dermatitis Control Tool (ADCT) score
The Atopic Dermatitis Control Tool (ADCT) is a validated tool to evaluate the different dimensions of patient-perceived atopic dermatitis (AD) control. It consists of 6 questions, each scored from 0 to 4. The minimum total ADCT score is 0 (best result) and the maximum total ADCT score is 24 (worst result).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Eczema Area and Severity Index (EASI) 75 response at Trial Week 24 and the Follow-up Visit (Week 33)
The Eczema Area and Severity Index (EASI) response in those participants who had an EASI 75 response at Trial Week 24 and did not need any systemic treatment for AD (relapse) until the Follow-up Visit.
The EASI is an investigator-assessed instrument for measuring the severity of clinical symptoms in atopic dermatitis (AD). The minimum EASI score is 0 (= normal) and the maximum EASI score is 72 (= very severe).
Measured: Trial Week 24, Trial Week 33
Scoring Atopic Dermatitis (SCORAD) 90 response
Response is defined as an improvement from baseline of at least 90%.
The Scoring Atopic Dermatitis (SCORAD) evaluates the extent and severity of eczema in atopic dermatitis (AD) based on affected body area and intensity of plaque characteristics.It comprises 3 areas: Area, Intensity and Subjective Symptoms. The final result range is between 0 (best result) and 103 (worst result).
Measured: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start27 Feb 2024
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 participants (estimated)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audrey Nosbaum, MD PhD, Principal investigator, Université Lyon 1 / INSERM U1111 - CIRI / Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239311
- Sponsor's protocol ID
- MC-MTX.18/AD
- Other IDs
- 2023-504443-13-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 11 Jan 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06239311
- Acronym / sponsor ID
- MC-MTX.18/AD
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 277 participants (estimated)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: MethotrexateParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 16 to 24 weekly subcutaneous injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman of childbearing potential must have a negative pregnancy test at the Screening Visit and must agree to use highly effective methods of contraception while taking the investigational medicinal product (IMP) and for 6 months after the last IMP administration. Men must agree to use a condom during intercourse while taking the IMP and for 3 months after the last IMP administration. They must also agree to not donate sperm for the time period starting at the Screening Visit, throughout the entire trial period, and for at least 3 months after the last IMP administration.
- 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
Key exclusion criteria (28 listed)
- Pregnant or breast-feeding women, or planning to become pregnant, or to breastfeed during the trial
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateSolution for injection in prefilled pen | Drug | Methotrexate |
| PlaceboSolution for injection in prefilled pen | Drug | Placebo |
Primary outcome
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) and the maximum EASI score is 72 (= very severe).
22 secondary outcomes
Improvement from baseline of at least 50% in the Eczema Area and Severity Index (EASI 50 response)
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Improvement from baseline of at least 75% in the Eczema Area and Severity Index (EASI 75 response)
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 24
Improvement from baseline of at least 90% in the Eczema Area and Severity Index (EASI 90 response)
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in the Eczema Area and Severity Index (EASI) score.
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Scoring Atopic Dermatitis (SCORAD) 50 response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Scoring Atopic Dermatitis (SCORAD) 75 response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16,
Change in Scoring Atopic Dermatitis (SCORAD) score from baseline
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Investigator Global Assessment (IGA) response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16, Trial Week 24
Pruritus Numerical Rating Scale (NRS) response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16, Trial Week 24
Change from baseline in Pruritus Numerical Rating Scale (NRS) score
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Patient-oriented Eczema Measure (POEM) response
Time frame: Trial Week 8, Trial Week 16
Change from baseline in POEM score
Time frame: Trial Week 8, Trial Week 16
Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) and serious adverse reactions (SARs)
Time frame: Trial Week 16, Trial Week 20, Trial Week 24, Trial Week 33
Dermatology Life Quality Index (DLQI) response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Dermatology Life Quality Index (DLQI) score.
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Scoring Atopic Dermatitis (SCORAD) sleep score
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Change from baseline in Work Productivity and Activity Impairment: General Health (WPAI:GH)
Time frame: Trial Week 8, Trial Week 16
Change from baseline in Hospital Anxiety and Depression (HADS) score and subscales
Time frame: Trial Week 8, Trial Week 16
Change from baseline in European Quality of Life (EuroQoL) Group 5 Dimension 5 Levels (EQ-5D-5L)
Time frame: Trial Week 8, Trial Week 16
Change from baseline in Atopic Dermatitis Control Tool (ADCT) score
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Eczema Area and Severity Index (EASI) 75 response at Trial Week 24 and the Follow-up Visit (Week 33)
Time frame: Trial Week 24, Trial Week 33
Scoring Atopic Dermatitis (SCORAD) 90 response
Time frame: Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Nosbaum, MD PhD principal investigator
Université Lyon 1 / INSERM U1111 - CIRI / Hospices Civils de Lyon
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with Moderate to Severe Atopic Dermatitis, run by medac GmbH at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Poland, Czechia, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medac Clinical Trial Information (+49 (0)4103 8006 ext. 0, ClinicalTrialInformation@medac.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) 75 response at Trial Week 16 Visit (time frame: Trial Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.