Chronic Obstructive Pulmonary Disease (COPD)Phase 3OBERONNCT05166889

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

A Phase 3 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 212 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Tozorakimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,132 participants
Where: 212 sitesin 21 countries
Study dates: 3 Jan 2022to 11 Mar 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Documented diagnosis of COPD for at least one year prior to enrolment.
Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
Smoking history of ≥ 10 pack-years.
CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2.

Who cannot join

Clinically important pulmonary disease other than COPD.
Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.

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Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
Significant COVID-19 illness within the 6 months prior to enrolment.
Unstable cardiovascular disorder.
Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
Evidence of active liver disease, including jaundice during screening.
Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
Participants who have evidence of active TB.
Participants that have previously received tozorakimab.
Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

Trial locations and contacts

212 sites in 21 countries.

Country

City, postcode or hospital

212 sites in 21 countries

Japan37 sites

Research Site
Asahikawa-shi, 078-8510
Research Site
Chikushino-shi, 818-8502
Research Site
Chūōku, 103-0022
Research Site
Fujieda-shi, 426-8677
Research Site
Fukuoka, 819-8555
Research Site
Hamamatsu, 430-8525
Research Site
Hamamatsu, 431-3192
Research Site
Hiroshima, 734-8530
Research Site
Iizuka-shi, 820-8505
Research Site
Iwata-shi, 438-8550
Research Site
Joyo-shi, 610-0113
Research Site
Kagoshima, 890-8520
Research Site
Kanazawa, 920-8650
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kitakyusyu-shi, 806-8501
Research Site
Kobe, 651-0072
Research Site
Koga-shi, 811-3195
Research Site
Kokubunji-shi, 185-0014
Research Site
Matsusaka-shi, 515-8544
Research Site
Mizunami-shi, 509-6134
Research Site
Nagaoka-shi, 940-8621
Research Site
Nagoya, 460-0001
Research Site
Obihiro, 080-0017
Research Site
Okayama, 700-8558
Research Site
Osaka, 531-0073
Research Site
Osaka, 543-8555
Research Site
Osaka, 545-8586
Research Site
Sakaishi, 590-0064
Research Site
Shinjuku-ku, 162-8655
Research Site
Shizuoka, 420-8630
Research Site
tabashi City, 173-8610
Research Site
Toshima-ku, 170-0003
Research Site
Toyonaka-shi, 560-8552
Research Site
Yanagawa-shi, 832-0059
Research Site
Yokohama, 221-0855
Research Site
Yokohama, 223-0059
Research Site
Yokohama, 232-0024

Other trials in Japan

United States36 sites

Research Site
Bakersfield, California, 93301
Research Site
Baltimore, Maryland, 21224
Research Site
Baton Rouge, Louisiana, 70816
Research Site
Boynton Beach, Florida, 33435
Research Site
Brick, New Jersey, 08724
Research Site
Burlington, Vermont, 05401
Research Site
Charlotte, North Carolina, 28277
Research Site
DuBois, Pennsylvania, 15801
Research Site
Durham, North Carolina, 27710
Research Site
Evergreen Park, Illinois, 60805
Research Site
Fargo, North Dakota, 58104
Research Site
Franklin, Tennessee, 37067
Research Site
Gastonia, North Carolina, 28054
Research Site
Houston, Texas, 77022
Research Site
Huntsville, Alabama, 35801
Research Site
Iowa City, Iowa, 52242
Research Site
Kansas City, Kansas, 66104
Research Site
Kingwood, Texas, 77339
Research Site
Meridian, Idaho, 83642
Research Site
Missoula, Montana, 59808
Research Site
Mobile, Alabama, 36608
Research Site
Montgomery, Alabama, 36106
Research Site
New York, New York, 10037
Research Site
Normal, Illinois, 61761
Research Site
Ormond Beach, Florida, 32174
Research Site
Phoenix, Arizona, 85044
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plantation, Florida, 33324
Research Site
Rapid City, South Dakota, 57702
Research Site
Rochester, Minnesota, 55905
Research Site
Sacramento, California, 95821
Research Site
Salt Lake City, Utah, 84108
Research Site
Sayre, Pennsylvania, 18840
Research Site
St Louis, Missouri, 63110
Research Site
The Bronx, New York, 10455
Research Site
Zachary, Louisiana, 70791

Other trials in United States

Canada14 sites

Research Site
Ajax, Ontario, L1S 2J5
Research Site
Calgary, Alberta, T3E 7M8
Research Site
Edmonton, Alberta, T5A 4L8
Research Site
Guelph, Ontario, N1H 6J2
Research Site
Kamloops, British Columbia, V2C 5T1
Research Site
Kelowna, British Columbia, V1Y 4N7
Research Site
Markham, Ontario, L3T 0C8
Research Site
Montreal, PQ, H3T 1E2
Research Site
Québec, Quebec, G1G 5X1
Research Site
Québec, Quebec, G1V 4G5
Research Site
Sherwood Park, Alberta, T8L 0N2
Research Site
Stouffville, Ontario, L4A 1H2
Research Site
Terrebonne, Quebec, J6V 2H2
Research Site
Winchester, Ontario, K0C 2K0

Other trials in Canada

Bulgaria12 sites

Research Site
Dupnitsa, 2600
Research Site
Haskovo, 6305
Research Site
Kozloduy, 3320
Research Site
Lovech, 5500
Research Site
Petrich, 2850
Research Site
Pleven, 5800
Research Site
Rousse, 7002
Research Site
Sliven, 8800
Research Site
Sofia, 1000
Research Site
Sofia, 1606
Research Site
Troyan Municipality, 5600
Research Site
Vratsa, 3000

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India12 sites

Research Site
Ahmedabad, 382415
Research Site
Belagavi, 590010
Research Site
Coimbatore, 641028
Research Site
Dehradun, 248001
Research Site
Hyderabad, 500038
Research Site
Jaipur, 302039
Research Site
Mohali, 160062
Research Site
Nagpur, 440012
Research Site
Nashik, 422007
Research Site
New Delhi, 110029
Research Site
Surat, 395009
Research Site
Thane, 401107

Other trials in India

Argentina11 sites

Research Site
Buenos Aires, C1121 ABE
Research Site
CABA, C1425BEN
Research Site
Ciudad de Buenos Aires, C1414AIF
Research Site
Córdoba, X5003DCE
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600GWV
Research Site
Mendoza, M5500CCG
Research Site
Quilmes, B1878FNR
Research Site
San Fernando, B1646EBJ
Research Site
San Juan Bautista, 1888
Research Site
San Miguel de Tucumán, 4000

Other trials in Argentina

Mexico10 sites

Research Site
Benito Juárez, 03650
Research Site
Chihuahua City, 31000
Research Site
Guadalajara, 44100
Research Site
Guadalajara, 44200
Research Site
Mérida, 97070
Research Site
Mexico City, 0 3100
Research Site
Monterrey, 64460
Research Site
Morelia, 58000
Research Site
Oaxaca City, 68020
Research Site
Veracruz, 91910

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South Korea8 sites

Research Site
Daegu, 42415
Research Site
Incheon, 21431
Research Site
Jeonju, 54907
Research Site
Seoul, 03722
Research Site
Seoul, 05030
Research Site
Seoul, 05505
Research Site
Seoul, 06591
Research Site
Seoul, 07061

Other trials in South Korea

Spain8 sites

Research Site
Galdakao, 48960
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Mérida, 06800
Research Site
Pozuelo de Alarcón, 28223
Research Site
Santander, 39008
Research Site
Valencia, 46010
Research Site
Zaragoza, 50009

Other trials in Spain

Hungary7 sites

Research Site
Budapest, 1036
Research Site
Debrecen, 4032
Research Site
Edelény, 3780
Research Site
Encs, 3860
Research Site
Mosonmagyaróvár, 9200
Research Site
Nyíregyháza-Sóstóhegy, 4481
Research Site
Százhalombatta, 2440

Other trials in Hungary

Netherlands7 sites

Research Site
Alkmaar, 1815 JD
Research Site
Eindhoven, 5623EJ
Research Site
Groningen, 9713 GZ
Research Site
Harderwijk, 3844 DG
Research Site
Heerlen, 6419 PC
Research Site
Zutphen, 7207 AE
Research Site
Zwolle, 8025 AB

Other trials in Netherlands

Norway7 sites

Research Site
Ålesund, 6017
Research Site
Bergen, 5021
Research Site
Bodø, 8092
Research Site
Levanger, 7600
Research Site
Lørenskog, 1478
Research Site
Oslo, 0450
Research Site
Tønsberg, 3103

Other trials in Norway

Czechia6 sites

Research Site
Brno, 625 00
Research Site
Broumov, 55001
Research Site
Jindřichův Hradec, 377 01
Research Site
Liberec, 460 63
Research Site
Olomouc, 779 00
Research Site
Rokycany, 337 22

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Denmark6 sites

Research Site
Aalborg, 9000
Research Site
Hvidovre, 2650
Research Site
København NV, 2400
Research Site
Næstved, 4700
Research Site
Roskilde, 4000
Research Site
Vejle, 7100

Other trials in Denmark

Finland6 sites

Research Site
Hämeenlinna, 13530
Research Site
Helsinki, 00290
Research Site
Kuopio, 70210
Research Site
Tampere, 33520
Research Site
Turku, 20100
Research Site
Turku, FI-20521

Other trials in Finland

Portugal6 sites

Research Site
Guimarães, 4835-235
Research Site
Lisbon, 1769-001
Research Site
Lisbon, 1998-018
Research Site
Matosinhos Municipality, 4454-509
Research Site
Vila Franca de Xira, 2600-009
Research Site
Vila Nova de Gaia, 4434-502

Other trials in Portugal

Turkey (Türkiye)6 sites

Research Site
Ankara, 06620
Research Site
Aydin, 09100
Research Site
Istanbul, 34069
Research Site
Izmir, 35040
Research Site
Izmir, 35965
Research Site
Mersin, 33343

Other trials in Turkey (Türkiye)

Belgium5 sites

Research Site
Brussels, 1000
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Namur, 5101

Other trials in Belgium

Sweden5 sites

Research Site
Gothenburg, 413 45
Research Site
Gothenburg, 413 46
Research Site
Lund, 222 22
Research Site
Malmö, 205 02
Research Site
Stockholm, 11239

Other trials in Sweden

Vietnam2 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000

Other trials in Vietnam

Puerto Rico1 site

Research Site
Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (OBERON)

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.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Tozorakimab, Placebo
Keywords: Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, exacerbations, ICS, LABA/LAMA
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TozorakimabDrug
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
TozorakimabDrug
Administered subcutaneously tozorakimab Dose 2 through Week 52.
PlaceboDrug
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

Study groups in NCT05166889
Study group	Role	What they receive
Tozorakimab Dose 1	Experimental	Dosing subcutaneously tozorakimab Dose 1 and placebo Receives: Drug: Tozorakimab
Tozorakimab Dose 2	Experimental	Dosing subcutaneously tozorakimab Dose 2 Receives: Drug: Tozorakimab
Placebo	Placebo comparator	Dosing subcutaneously with equivalent volume to tozorakimab Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
The primary endpoint will be assessed first in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy [triple therapy, or dual therapy if triple is not considered appropriate]) and then assessed in the overall population of participants.
Measured: over 52 weeks

Secondary outcomes (21)

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
The annualized rate will be assessed in the overall population of participants including current and former smokers with symptomatic COPD and history of exacerbations, on optimised treatment with maintenance inhaled therapy.
Measured: over 52 weeks
Time to first moderate to severe COPD exacerbation in former smokers.
To explore the extent to which treatment with each dose of tozorakimab delays the time to first exacerbation compared with placebo in former smokers.
Measured: over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers.
Measured: Week 52, or over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in the overall population of current and former smokers.
Measured: Week 52, or over 52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers.
Responder analyses for E-RS:COPD total score at Week 52 based upon a ≥ 2 point improvement (decrease) from baseline in former smokers.
Measured: Week 52
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Responder analyses for E-RS:COPD total score at Week 52 based upon a ≥ 2 point improvement (decrease) from baseline in the overall population of current and former smokers.
Measured: Week 52
Mean change from baseline in E-RS:COPD total score in former smokers.
Difference in mean change in E-RS:COPD total score from baseline in former smokers.
Measured: over 52 weeks
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Difference in mean change in E-RS:COPD total score from baseline in the overall population of current and former smokers.
Measured: over 52 weeks
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline in former smokers.
Measured: Week 52
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline in the overall population of current and former smokers.
Measured: Week 52
Mean change from baseline in SGRQ total score from in former smokers.
Difference in mean change from baseline in SGRQ total score in former smokers.
Measured: over 52 weeks
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers
Difference in mean change from baseline in SGRQ total score in the overall population of current and former smokers.
Measured: over 52 weeks
Time to first severe COPD exacerbation in former smokers.
To evaluate hazard ratio of first severe COPD exacerbation in former smokers.
Measured: over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers.
The rate ratio of severe COPD exacerbations will be assessed in former smokers.
Measured: over 52 weeks
Change from baseline in CAT total score.
Analyses of change from baseline in CAT total score in former smokers.
Measured: Week 52
Percentage of participants with a decrease in CAT total score in former smokers.
Proportion of participants achieving MCID in CAT total score, a decrease in CAT total score of ≥ 2 points from baseline in former smokers.
Measured: Week 52
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Measured: over 52 weeks
Annualized rate of healthcare resource utilization in former smokers.
Annualized rate of healthcare resource utilization in former smokers.
Measured: over 52 weeks
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Difference in mean number of puffs per day from baseline.
Measured: over 52 weeks
Trough serum concentrations of tozorakimab.
Pharmacokinetics: concentrations of tozorakimab in trough serum.
Measured: over 52 weeks
Presence of anti-drug antibodies.
Immunogenicity: presence of tozorakimab anti-drug antibodies in blood serum.
Measured: over 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202211 Mar 2026

First posted22 Dec 2021
Study start3 Jan 2022
Primary completion19 Jan 2026
Study completion11 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05166889
Sponsor's protocol ID: D9180C00003
Other IDs: 2023-503571-19-00, 2021-003797-30, 2023
Acronym: OBERON
Status last verified: Apr 2026
First submitted: 9 Dec 2021
Last updated: 16 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Sciurba FC, Watz H, Bourdin A, Janssens W, Martinez FJ, Zheng J, van den Berge M, Bonini M, Han MK, Singh D, Criner GJ, Brightling CE, Papi A, Bhatt SP, Jenkins M, Mikosz M, Cholbinski P, Ziemiecka M, Lofdahl M, Arya D, Yadavalli M, Brodek BH, Fageras M, Bardsley S, Martin N, Patel R, Psallidas I; OBERON and TITANIA Trial Investigators. Tozorakimab to Prevent COPD Exacerbations. N Engl J Med. 2026 Sep 8. doi: 10.1056/NEJMoa2606998. Online ahead of print.
PubMed 42708515
Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.
PubMed 42476723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (OBERON)
ClinicalTrials.gov ID: NCT05166889
Acronym / sponsor ID: OBERON / D9180C00003
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, exacerbations, ICS, LABA/LAMA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,132 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 3 Jan 2022 (actual)
Primary completion: 19 Jan 2026 (actual)
Study completion: 11 Mar 2026 (actual)
First posted: 22 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Tozorakimab Dose 1	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 1 and placebo
Tozorakimab Dose 2	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 2
Placebo	Placebo comparator	Drug: PlaceboDosing subcutaneously with equivalent volume to tozorakimab

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Documented diagnosis of COPD for at least one year prior to enrolment.
Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.

Key exclusion criteria (18 listed)

Clinically important pulmonary disease other than COPD.
Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TozorakimabAdministered subcutaneously tozorakimab Dose 1 and placebo through Week 52.	Drug	Tozorakimab Dose 1
TozorakimabAdministered subcutaneously tozorakimab Dose 2 through Week 52.	Drug	Tozorakimab Dose 2
PlaceboPlacebo administered subcutaneously, equivalent volume to tozorakimab through week 52.	Drug	Placebo

Primary outcome

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Time frame: over 52 weeks
The primary endpoint will be assessed first in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy [triple therapy, or dual therapy if triple is not considered appropriate]) and then assessed in the overall population of participants.

21 secondary outcomes

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
Time frame: over 52 weeks
Time to first moderate to severe COPD exacerbation in former smokers.
Time frame: over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Time frame: Week 52, or over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
Time frame: Week 52, or over 52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers.
Time frame: Week 52
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Time frame: Week 52
Mean change from baseline in E-RS:COPD total score in former smokers.
Time frame: over 52 weeks
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Time frame: over 52 weeks
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Time frame: Week 52
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Time frame: Week 52
Mean change from baseline in SGRQ total score from in former smokers.
Time frame: over 52 weeks
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers
Time frame: over 52 weeks
Time to first severe COPD exacerbation in former smokers.
Time frame: over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers.
Time frame: over 52 weeks
Change from baseline in CAT total score.
Time frame: Week 52
Percentage of participants with a decrease in CAT total score in former smokers.
Time frame: Week 52
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Time frame: over 52 weeks
Annualized rate of healthcare resource utilization in former smokers.
Time frame: over 52 weeks
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Time frame: over 52 weeks
Trough serum concentrations of tozorakimab.
Time frame: over 52 weeks
Presence of anti-drug antibodies.
Time frame: over 60 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Derived from this study: PubMed 42708515Sciurba FC, Watz H, Bourdin A, Janssens W, Martinez FJ, Zheng J, van den Berge M, Bonini M, Han MK, Singh D, Criner GJ, Brightling CE, Papi A, Bhatt SP, Jenkins M, Mikosz M, Cholbinski P, Ziemiecka M, Lofdahl M, Arya D, Yadavalli M, Brodek BH, Fageras M, Bardsley S, Martin N, Patel R, Psallidas I; OBERON and TITANIA Trial Investigators. Tozorakimab to Prevent COPD Exacerbations. N Engl J Med. 2026 Sep 8. doi: 10.1056/NEJMoa2606998. Online ahead of print.
Derived from this study: PubMed 42476723Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

212 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 212 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in Japan, United States, Canada, Bulgaria, India and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers. (time frame: over 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05166889, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.