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BibTex format

@article{Corren:2026:10.1183/23120541.00183-2025,
author = {Corren, J and Reid, F and Moate, R and Jimenez, E and Sadiq, MW and Williams, A and Rytelewski, M and Cameron-Christie, S and Muthas, D and Georgi, B and Brooks, D and Lindqvist, E and Kell, C and Platt, A and Belvisi, MG and Pandya, H},
doi = {10.1183/23120541.00183-2025},
journal = {ERJ Open Res},
title = {FRONTIER-3: a randomised phase 2a study to investigate tozorakimab, an anti-interleukin-33 monoclonal antibody, in early-onset asthma.},
url = {http://dx.doi.org/10.1183/23120541.00183-2025},
volume = {12},
year = {2026}
}
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TY  - JOUR
AB  - BACKGROUND: Interleukin (IL)-33 is implicated in the initiation and progression of asthma. FRONTIER-3 (NCT04570657) was a phase 2a study to investigate tozorakimab, an anti-IL-33 monoclonal antibody, in adults with moderate-to-severe early-onset asthma receiving standard of care. METHODS: Patients were randomised 1:1:1 to tozorakimab 600mg, tozorakimab 300mg or placebo, once every 4weeks subcutaneously. The primary end-point was change from baseline to week 16 in pre-bronchodilator (pre-BD) forced expiratory volume in 1s (FEV1) measured in clinic. Secondary and exploratory end-points included home pre-BD FEV1, home peak expiratory flow (PEF), rescue medication use, CompEx, pharmacokinetics, immunogenicity and safety. RESULTS: The intent-to-treat (ITT) population included 235 patients with a median disease duration of >30years; a majority had a baseline blood eosinophil count (BEC) <300cells·μL-1. At week 16, tozorakimab did not show a statistically significant improvement in change from baseline in clinic pre-BD FEV1 versus placebo (least-squares mean difference (LSMD) (80% CI), 600mg: 4mL (-71-79), p=0.473; 300mg: 36mL (-38-111), p=0.267). Compared with the ITT population, a pre-specified subgroup of patients with ≥2 prior exacerbations showed greater improvements in clinic pre-BD FEV1 at week 16 with tozorakimab versus placebo (LSMD (80% CI), 600mg: 212mL (102-322), p=0.007; 300mg: 77mL (-34-187), p=0.186). Tozorakimab also showed greater improvements in home FEV1 and home PEF versus placebo at week 16 in patients with ≥2 prior exacerbations than in the ITT population. Tozorakimab was well tolerated. CONCLUSIONS: Although FRONTIER-3 did not meet the primary study end-point, tozorakimab treatment showed encouraging efficacy signals in patients with early-onset asthma and a history of exacerbations.
AU  - Corren,J
AU  - Reid,F
AU  - Moate,R
AU  - Jimenez,E
AU  - Sadiq,MW
AU  - Williams,A
AU  - Rytelewski,M
AU  - Cameron-Christie,S
AU  - Muthas,D
AU  - Georgi,B
AU  - Brooks,D
AU  - Lindqvist,E
AU  - Kell,C
AU  - Platt,A
AU  - Belvisi,MG
AU  - Pandya,H
DO  - 10.1183/23120541.00183-2025
PY  - 2026///
SN  - 2312-0541
TI  - FRONTIER-3: a randomised phase 2a study to investigate tozorakimab, an anti-interleukin-33 monoclonal antibody, in early-onset asthma.
T2  - ERJ Open Res
UR  - http://dx.doi.org/10.1183/23120541.00183-2025
UR  - https://www.ncbi.nlm.nih.gov/pubmed/41736737
VL  - 12
ER  -
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