ArticleDermatology and therapy2025
Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05656911 (A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib), which is not on this map. Cited by 1 paper.
What it found
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The trial behind it
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A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib (BAY 1834845) for the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
Who cites it
1 citing paper in PubMed.
- Toll-like receptors in innate immunity and inflammation: from fundamental biology to clinic insights.Immunity & inflammation · 2026Review
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInterleukin-1 receptor-associated kinase 4 (IRAK4) is expressed in various immune cells and regulates proinflammatory cytokine production. Its inhibition represents a novel, promising therapeutic option in the treatment of atopic dermatitis (AD). Zabedosertib (BAY1834845) is a potent, selective IRAK4 inhibitor that suppresses markers of local and systemic immune responses. This study aimed to evaluate the efficacy and safety of zabedosertib in adults with moderate-to-severe AD.
methodsDAMASK was a randomized, double-blind, 12-week, placebo-controlled, phase 2a, proof-of-concept study. Patients were randomized 2:1 to receive oral zabedosertib 120 mg twice daily or placebo. The primary efficacy endpoint was a composite of 75% reduction from baseline on the Eczema Area and Severity Index (EASI-75), no discontinuation of study medication for lack of efficacy, no rescue medication during the 4 weeks before Day 84, and no initiation of systemic AD treatment. Other efficacy assessments included validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), Peak Pruritus numerical rating scale score, and affected body surface area (BSA); for safety, it included frequency and severity of treatment-emergent adverse events (TEAEs).
resultsOf 77 randomized patients, 69 were included in the primary efficacy analysis (zabedosertib, n = 47; placebo, n = 22); 55 patients completed treatment. At Week 12, there was no significant difference between zabedosertib and placebo in the primary efficacy endpoint (32.3% vs. 37.4%) or percentage change in EASI from baseline (- 44.6% vs. - 55.9%). There were also no significant differences between zabedosertib and placebo at Week 12 in vIGA-AD response (15.9% vs. 28.5%), Peak Pruritus response (16.4% vs. 25.0%), percentage change in Peak Pruritus (- 20.7% vs. - 27.3%), or percentage change in BSA affected by AD (- 13.3% vs. - 20.3%). No severe or serious TEAEs were reported throughout the study.
conclusionsZabedosertib was safe and well tolerated in adults with moderate-to-severe AD but showed no evidence of efficacy in reducing disease severity or pruritus in this placebo-controlled study.
trial registrationClinicalTrials.gov identifier, NCT05656911.
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