ArticleDermatology and therapy2026
Efficacy and Safety of the PD-1 Agonist JNJ-67484703 in Participants with Atopic Dermatitis: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial Results.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionAtopic dermatitis (AD) is a chronic, inflammatory skin disease with a high burden and unmet needs. Herein, we have assessed the efficacy and safety of JNJ-67484703, a programmed cell death protein 1 (PD-1)-agonizing/depleting humanized immunoglobulin G1 antibody, as a novel therapeutic approach in patients with AD.
methodsIn this phase 2a, double-blind, placebo-controlled study, adults with moderate-to-severe AD (Eczema Area and Severity Index [EASI] score ≥ 16) and an inadequate response to standard treatments were randomized (2:1) to receive JNJ-67484703 (3 mg/kg) or placebo by subcutaneous injection for 12 weeks. The primary endpoint was the proportion of participants achieving ≥ 75% improvement in EASI score (EASI-75) from baseline at week 12. Key secondary and exploratory endpoints included percentage change from baseline in EASI score, ≥ 50% improvement in EASI score (EASI-50), and change in SCORing Atopic Dermatitis (SCORAD) score at week 12. Safety, immunogenicity, and pharmacodynamics were assessed through week 36.
resultsFifty-one participants were randomized (JNJ-67484703: n = 34; placebo: n = 17). At week 12, a numerically higher proportion of participants in the JNJ-67484703 group achieved EASI-75 response versus placebo (25.0% vs 11.8%; least-squares mean [LSM] difference 13.2% 90% confidence interval [CI] - 4.8, 31.2]; P = 0.4590). Percentage improvement in EASI score was numerically greater with JNJ-67484703 versus placebo (- 41.0% vs - 20.8%; LSM difference - 20.1%, 90% CI - 41.5, 1.3). Similar numerically greater improvements with JNJ-67484703 were observed for EASI-50 and SCORAD scores. Adverse event rates were comparable between the JNJ-67484703 (88.2%) and placebo (82.4%) groups. Two participants developed antibodies against JNJ-67484703 without pharmacokinetic impact. JNJ-67484703 induced rapid, sustained, reversible depletion of PD-1-expressing T cells, with greater median percentage reduction of PD-1
conclusionIn this phase 2a trial in adults with moderate-to-severe AD, JNJ-67484703 was well-tolerated but did not demonstrate statistically significant benefit versus placebo.
trial registrationEudraCT 2022-001528-14.
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