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

Conditions

moderate to severe atopic dermatitis

Brief summary

EASI 75 response at the Trial Week 16 Visit

Detailed description

EASI, SCORAD, IGA, NRS and POEM scores or responses at different time points including Trial Week 4, Trial Week 8, Trial Week 12 and Trial Week 16, Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) occurring from the Screening Visit until the Trial Week 16/24 Visit, and serious adverse reactions (SARs) occurring from start of the trial intervention until Trial Week 20/33 Visit - time points depending on participation in the extension phase or not. Change in vital signs and laboratory values., Change in DLQI, SCORAD, WPAI:GH, HADS, EQ-5D-5L and ADCT scores or responses from baseline to different time points including Trial Week 4, Trial Week 8, Trial Week 12, and Trial Week 16, EASI, IGA, NRS, SCORAD, DLQI, WPAI:GH, HADS, EQ-5D-5L and ADCT responses at Trial Week 24 or change in scores or responses between Trial Week 16 and Trial Week 24

Related papers

No related papers found yet.

Interventions

DRUGMETHOTREXATE

DRUGDESOXIMETASONE

DRUGAcidum folicum Léčiva 10 mg obalené tablety

DRUGplacebo

DRUGTACROLIMUS

DRUGFOLIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
EASI 75 response at the Trial Week 16 Visit	—

Secondary

Measure	Time frame
EASI, SCORAD, IGA, NRS and POEM scores or responses at different time points including Trial Week 4, Trial Week 8, Trial Week 12 and Trial Week 16, Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) occurring from the Screening Visit until the Trial Week 16/24 Visit, and serious adverse reactions (SARs) occurring from start of the trial intervention until Trial Week 20/33 Visit - time points depending on participation in the extension phase or not. Change in vital signs and laboratory values., Change in DLQI, SCORAD, WPAI:GH, HADS, EQ-5D-5L and ADCT scores or responses from baseline to different time points including Trial Week 4, Trial Week 8, Trial Week 12, and Trial Week 16, EASI, IGA, NRS, SCORAD, DLQI, WPAI:GH, HADS, EQ-5D-5L and ADCT responses at Trial Week 24 or change in scores or responses between Trial Week 16 and Trial Week 24	—

Measure

Time frame

EASI, SCORAD, IGA, NRS and POEM scores or responses at different time points including Trial Week 4, Trial Week 8, Trial Week 12 and Trial Week 16, Adverse events (AE), treatment-related AEs, serious adverse events (SAEs) occurring from the Screening Visit until the Trial Week 16/24 Visit, and serious adverse reactions (SARs) occurring from start of the trial intervention until Trial Week 20/33 Visit - time points depending on participation in the extension phase or not. Change in vital signs and laboratory values., Change in DLQI, SCORAD, WPAI:GH, HADS, EQ-5D-5L and ADCT scores or responses from baseline to different time points including Trial Week 4, Trial Week 8, Trial Week 12, and Trial Week 16, EASI, IGA, NRS, SCORAD, DLQI, WPAI:GH, HADS, EQ-5D-5L and ADCT responses at Trial Week 24 or change in scores or responses between Trial Week 16 and Trial Week 24

—

Countries

Czechia, France, Italy, Poland

Outcome results

None listed