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Amlitelimab, an anti-OX40 ligand antibody, for atopic dermatitis: a plain language summary of STREAM-AD clinical study.
Immunotherapy
September 2025
kSanofi, Paris, France.
Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab.
J Eur Acad Dermatol Venereol
July 2025
Sanofi, Boston, Massachusetts, USA.
Background: Amlitelimab, a fully human, nondepleting, anti-OX40 ligand monoclonal antibody, demonstrated reductions in lesional and pruritic endpoints in adults with moderate-to-severe atopic dermatitis (AD) in phase 2a and 2b trials.
Objectives: Here, we examined the effect and durability of amlitelimab on clinical outcome assessments (COAs) in the randomized STREAM-AD phase 2b trial.
Methods: Adults with moderate-to-severe AD with prior inadequate response to or inadvisability of topical medications received subcutaneous amlitelimab (250 mg with 500-mg loading dose, 250 mg, 125 mg or 62.
Safety and Efficacy of Anti-OX40 Therapies in Atopic Dermatitis: A Systematic Review and Meta-Analysis.
Dermatitis
April 2025
Teaching Assistant II-Post-graduate Program, Harvard T.H. Chan School of Public Health, Principles and Practice of Clinical Research, ECPE, Boston, Massachusetts, USA.
Atopic dermatitis (AD) is a chronic inflammatory skin disorder that significantly impacts patients' quality of life. Novel biological agents targeting the OX40 pathway have shown promise in refractory cases. We aimed to systematically evaluate the efficacy and safety of anti-OX40 therapies (amlitelimab, rocatinlimab, and telazorlimab) in moderate-to-severe AD.
View Article and Find Full Text PDFPhase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis.
J Allergy Clin Immunol
April 2025
Sanofi, Paris, France.
Background: Amlitelimab, a fully human nondepleting mAb targeting OX40 ligand on antigen-presenting cells, could prevent T-cell-driven inflammation seen in atopic dermatitis (AD).
Objective: This trial evaluated the efficacy and safety of amlitelimab in adults with AD.
Methods: In this 2-part, phase 2b, randomized, double-blinded placebo-controlled trial (ClinicalTrials.
Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial.
Br J Dermatol
October 2023
Sanofi, Cambridge, UK.
Background: Atopic dermatitis (AD) is an inflammatory skin disease with significant unmet need. Blockade of the OX40-OX40 ligand (OX40L) costimulation pathway by targeting OX40L on antigen-presenting cells (APCs) with a fully human noncytotoxic, nondepleting anti-OX40L monoclonal antibody (amlitelimab; SAR445229; KY1005) is a novel way to modulate persistent inflammation.
Objectives: To assess the safety and efficacy of amlitelimab over 16 weeks in adults with AD in a phase IIa double-blind placebo-controlled study.