Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
ConditionModerate to Severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
Sponsormedac GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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))
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate
DrugSolution for injection in prefilled pen
Placebo
DrugSolution for injection in prefilled pen
Treatment groups
277 Participants
are divided into 2 treatment groupsGroup A: MethotrexateActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Trial Week 16Secondary outcomes
1
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).
Time frame
Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 162
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).
Time frame
Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 243
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).
Time frame
Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 164
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).
Time frame
Trial Week 4, Trial Week 8, Trial Week 12, Trial Week 16 Source ClinicalTrials.gov