NCT05166889: OBERON

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

Completed Phase 3 Last updated 16 April 2026

What this trial tests

Phase 3 trial testing Tozorakimab in Chronic Obstructive Pulmonary Disease (COPD) in 1,132 participants. Completed in 11 March 2026.

Timeline

3 January 2022

Primary endpoint
19 January 2026

11 March 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,132
Start date	3 January 2022
Primary completion	19 January 2026
Estimated completion	11 March 2026
Sites	212 locations across Finland, Japan, Vietnam, South Korea, Denmark, Netherlands, Belgium, Sweden

Drugs / interventions tested

• Tozorakimab — full drug profile →
• Tozorakimab — full drug profile →
• Placebo

Conditions studied

• Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 40 to 130, any sex, with Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tozorakimab (MEDI3506): an anti-IL-33 antibody that inhibits IL-33 signalling via ST2 and RAGE/EGFR to reduce inflammation and epithelial dysfunction.
   England E, Rees DG, Scott IC, Carmen S, et al · · 2023 · cited 85× · PMID 37330528 · DOI 10.1038/s41598-023-36642-y
2. Oxidised IL-33 drives COPD epithelial pathogenesis <i>via</i> ST2-independent RAGE/EGFR signalling complex.
   Strickson S, Houslay KF, Negri VA, Ohne Y, et al · · 2023 · cited 64× · PMID 37442582 · DOI 10.1183/13993003.02210-2022
3. Novel Anti-Inflammatory Approaches to COPD.
   Cazzola M, Hanania NA, Page CP, Matera MG. · · 2023 · cited 42× · PMID 37408603 · DOI 10.2147/copd.s419056
4. New insights into the pathophysiology and therapeutic targets of asthma and comorbid chronic rhinosinusitis with or without nasal polyposis.
   Striz I, Golebski K, Strizova Z, Loukides S, et al · · 2023 · cited 37× · PMID 37199256 · DOI 10.1042/cs20190281
5. Biologic drugs in the treatment of chronic inflammatory pulmonary diseases: recent developments and future perspectives.
   Plichta J, Kuna P, Panek M. · · 2023 · cited 34× · PMID 37334374 · DOI 10.3389/fimmu.2023.1207641
6. The Role of IL-33/ST2 in COPD and Its Future as an Antibody Therapy.
   Riera-Martínez L, Cànaves-Gómez L, Iglesias A, Martin-Medina A, et al · · 2023 · cited 27× · PMID 37240045 · DOI 10.3390/ijms24108702
7. Human Lung Mast Cells: Therapeutic Implications in Asthma.
   Poto R, Criscuolo G, Marone G, Brightling CE, et al · · 2022 · cited 26× · PMID 36430941 · DOI 10.3390/ijms232214466
8. Targeting alarmins in asthma: From bench to clinic.
   Akenroye A, Boyce JA, Kita H. · · 2025 · cited 24× · PMID 39855362 · DOI 10.1016/j.jaci.2025.01.017