AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3MIRANDANCT06040086

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 368 sites in 29 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Read more about this study

Who is it for?
Ages 40 to 130 years
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
1,454 participants
Where
368 sitesin 29 countries
Study dates
22 Sep 2023to 22 May 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 optimised inhaled dual or triple therapy 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. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.
  • 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 active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
  • 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.
  • History of partial or total lung resection.
  • Scheduled major surgical procedure during the course of the study.
  • 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.

Trial locations and contacts

368 sites in 29 countries.

368 sites in 29 countries

United States57 sites

  • Research Site

    Andover, Kansas, 67002

  • Research Site

    Atlanta, Georgia, 30344

  • Research Site

    Aurora, Colorado, 80014

  • Research Site

    Birmingham, Alabama, 35205

  • Research Site

    Boulder, Colorado, 80301

  • Research Site

    Bowling Green, Kentucky, 42101

  • Research Site

    Boynton Beach, Florida, 33435

  • Research Site

    Cape Coral, Florida, 33990

  • Research Site

    Champaign, Illinois, 61820

  • Research Site

    Charlotte, North Carolina, 28273

  • Research Site

    Chattanooga, Tennessee, 37404

  • Research Site

    Chesterfield, Missouri, 63005

  • Research Site

    Chesterfield, Missouri, 63017

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Chicago, Illinois, 60616

  • Research Site

    Dallas, Texas, 75254

  • Research Site

    Dayton, Ohio, 45439

  • Research Site

    Decatur, Alabama, 35603

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    El Paso, Texas, 79902

  • Research Site

    Elizabethton, Tennessee, 37643

  • Research Site

    Gaffney, South Carolina, 29340

  • Research Site

    Grants Pass, Oregon, 97527

  • Research Site

    Greenville, North Carolina, 27834

  • Research Site

    Hannibal, Missouri, 63401

  • Research Site

    Houston, Texas, 77008

  • Research Site

    Huntersville, North Carolina, 28078

  • Research Site

    Jackson, Tennessee, 38305

  • Research Site

    Kenosha, Wisconsin, 53142

  • Research Site

    Lakeland, Florida, 33805

  • Research Site

    Lakeland, Florida, 33813

  • Research Site

    Las Vegas, Nevada, 89102

  • Research Site

    Lexington, Kentucky, 40503

  • Research Site

    Lima, Ohio, 45801

  • Research Site

    Lithonia, Georgia, 30038

  • Research Site

    Los Angeles, California, 90027

  • Research Site

    McKinney, Texas, 75069

  • Research Site

    Minneapolis, Minnesota, 55425

  • Research Site

    Naples, Florida, 34102

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    Ocala, Florida, 34470

  • Research Site

    Ormond Beach, Florida, 32174

  • Research Site

    Papillion, Nebraska, 68046

  • Research Site

    Phoenix, Arizona, 85027

  • Research Site

    Roy, Utah, 84067

  • Research Site

    San Antonio, Texas, 78258

  • Research Site

    San Francisco, California, 94109

  • Research Site

    Sheffield, Alabama, 35660

  • Research Site

    The Bronx, New York, 10451

  • Research Site

    Toms River, New Jersey, 08755

  • Research Site

    Towson, Maryland, 21286

  • Research Site

    Tucson, Arizona, 85704

  • Research Site

    Union, South Carolina, 29379

  • Research Site

    Washington D.C., District of Columbia, 20037

  • Research Site

    Westminster, California, 92683

  • Research Site

    Winston-Salem, North Carolina, 27103

  • Research Site

    Yuma, Arizona, 85365

Other trials in United States

China44 sites

  • Research Site

    Beijing, 100029

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410015

  • Research Site

    Changsha, 430033

  • Research Site

    Chengdu, 610014

  • Research Site

    Chengdu, 610072

  • Research Site

    Chengdu, 611130

  • Research Site

    Chongqing, 400037

  • Research Site

    Chongqing, 400042

  • Research Site

    Guangzhou, 510145

  • Research Site

    Guangzhou, 510163

  • Research Site

    Guangzhou, 510515

  • Research Site

    Hefei, 230061

  • Research Site

    Hohhot, 750306

  • Research Site

    Huizhou, 516002

  • Research Site

    Jinan, 250001

  • Research Site

    Lanzhou, 730030

  • Research Site

    Liaocheng, 252000

  • Research Site

    Linhai, 317000

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanchong, 637000

  • Research Site

    Nanjing, 210006

  • Research Site

    Nanjing, 210009

  • Research Site

    Nanning, 530021

  • Research Site

    Ningbo, 315010

  • Research Site

    Pingxiang, 337055

  • Research Site

    Qingdao, 266000

  • Research Site

    Shanghai, 200040

  • Research Site

    Shanghai, 200240

  • Research Site

    Shanghai, 200433

  • Research Site

    Shanghai, 201199

  • Research Site

    Shenyang, 110004

  • Research Site

    Shenyang, 110016

  • Research Site

    Shenzhen, 518020

  • Research Site

    Shijiazhuang, 050051

  • Research Site

    Shijiazhuang, 50051

  • Research Site

    Taizhou, 318000

  • Research Site

    Wuhan, 430022

  • Research Site

    Wuhan, 430030

  • Research Site

    Xi'an, 710006

  • Research Site

    Xuzhou, 221000

  • Research Site

    Xuzhou, 221009

  • Research Site

    Yinchuan, 750004

  • Research Site

    Zigong, 643000

Other trials in China

Japan41 sites

  • Research Site

    Aomori, 030-8553

  • Research Site

    Asahikawa-shi, 070-8644

  • Research Site

    Chikushino-shi, 818-8502

  • Research Site

    Chūōku, 104-0031

  • Research Site

    Fujieda-shi, 426-8677

  • Research Site

    Fukuoka, 814-0180

  • Research Site

    Ginowan-shi, 901-2214

  • Research Site

    Habikino-shi, 583-8588

  • Research Site

    Hakodate-shi, 041-8680

  • Research Site

    Hamamatsu, 430-8525

  • Research Site

    Izumi-shi, 594-0073

  • Research Site

    Kagoshima, 892-0847

  • Research Site

    Kobe, 650-0047

  • Research Site

    Kusatsu-shi, 525-8585

  • Research Site

    Kyoto, 612-8555

  • Research Site

    Matsusaka-shi, 515-8544

  • Research Site

    Minoh, 562-0003

  • Research Site

    Minokamo Shi, 505-8510

  • Research Site

    Mizunami-shi, 509-6134

  • Research Site

    Morioka, 020-0066

  • Research Site

    Nagoya, 457-8511

  • Research Site

    Nankoku-shi, 783-8505

  • Research Site

    Nankoku-shi, 783-8509

  • Research Site

    Omuta-shi, 837-0911

  • Research Site

    Sagamihara-shi, 252-0143

  • Research Site

    Sagamihara-shi, 252-0315

  • Research Site

    Sakaide-shi, 762-8550

  • Research Site

    Sapporo, 006-8555

  • Research Site

    Sapporo, 064-0804

  • Research Site

    Shizuoka, 420-8630

  • Research Site

    tabashi City, 173-8610

  • Research Site

    Tachikawa-shi, 190-8531

  • Research Site

    Toon-shi, 791-0281

  • Research Site

    Toshima-ku, 171-0014

  • Research Site

    Toyonaka-shi, 560-8552

  • Research Site

    Ube, 755-8505

  • Research Site

    Yanagawa-shi, 832-0059

  • Research Site

    Yokohama, 221-0855

  • Research Site

    Yokohama, 232-0024

  • Research Site

    Yokohama, 232-0066

  • Research Site

    Yokohama, 236-0037

Other trials in Japan

Germany26 sites

  • Research Site

    Augsburg, 86150

  • Research Site

    Berlin, 10119

  • Research Site

    Berlin, 10717

  • Research Site

    Berlin, 10787

  • Research Site

    Berlin, 10961

  • Research Site

    Berlin, 12157

  • Research Site

    Berlin, 12159

  • Research Site

    Berlin, 12203

  • Research Site

    Berlin, 13187

  • Research Site

    Cologne, 51069

  • Research Site

    Darmstadt, 64283

  • Research Site

    Essen, 45127

  • Research Site

    Frankfurt, 60596

  • Research Site

    Frankfurt am Main, 60389

  • Research Site

    Großhansdorf, 22927

  • Research Site

    Halle, 06108

  • Research Site

    Halle, 06120

  • Research Site

    Hanover, 30159

  • Research Site

    Leipzig, 04299

  • Research Site

    Marburg, 35037

  • Research Site

    Moers, 47441

  • Research Site

    München, 80335

  • Research Site

    München-Pasing, 81241

  • Research Site

    Nuremberg, 90419

  • Research Site

    Peine, 31224

  • Research Site

    Solingen, 42699

Other trials in Germany

Argentina13 sites

  • Research Site

    Buenos Aires, C1121 ABE

  • Research Site

    CABA, C1025ABI

  • Research Site

    CABA, C1425BEN

  • Research Site

    Ciudad de Buenos Aires, C1414AIF

  • Research Site

    Córdoba, X5003DCE

  • Research Site

    La Plata, B1904

  • 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

Brazil13 sites

  • Research Site

    Barretos, 14784-400

  • Research Site

    Belo Horizonte, 30150-221

  • Research Site

    Blumenau, 89030-101

  • Research Site

    Campina Grande do Sul, 83.430-000

  • Research Site

    Campinas, 13060-080

  • Research Site

    Fortaleza, 60430-270

  • Research Site

    Porto Alegre, 90035074

  • Research Site

    Porto Alegre, 90610-000

  • Research Site

    Porto Alegre, 91010-006

  • Research Site

    São Bernardo do Campo, 09715090

  • Research Site

    São José do Rio Preto, 15090-000

  • Research Site

    São Paulo, 05403-000

  • Research Site

    Valinhos, 13271-130

Other trials in Brazil

India13 sites

  • Research Site

    Ajmer, 305001

  • Research Site

    Calicut, 673 008

  • Research Site

    Dehradun, 248001

  • Research Site

    Delhi, 110029

  • Research Site

    Dwārka, 110075

  • Research Site

    Hyderabad, 500035

  • Research Site

    Hyderabad, 500038

  • Research Site

    Jaipur, 302012

  • Research Site

    Jaipur, 302039

  • Research Site

    Kolkata, 700053

  • Research Site

    Nagpur, 440012

  • Research Site

    Vijayawada, 520 008

  • Research Site

    Visakhapatnam, 530017

Other trials in India

Ukraine12 sites

  • Research Site

    Chernivtsi, 58022

  • Research Site

    Ivano-Frankivsk, 76019

  • Research Site

    Kyiv, 02002

  • Research Site

    Kyiv, 02081

  • Research Site

    Kyiv, 03037

  • Research Site

    Kyiv, 03680

  • Research Site

    Tarasove Village, 45634

  • Research Site

    Ternopil, 46001

  • Research Site

    Uzhhorod, 88018

  • Research Site

    Vinnytsia, 21001

  • Research Site

    Vinnytsia, 21029

  • Research Site

    Zhytomyr, 100002

Other trials in Ukraine

France11 sites

  • Research Site

    Aix-en-Provence, 13100

  • Research Site

    Brest, 29609

  • Research Site

    Colmar, 68024

  • Research Site

    Epagny Metz-Tessy, 74370

  • Research Site

    La Tronche, 38700

  • Research Site

    Lyon, 69317

  • Research Site

    Marseille, 13015

  • Research Site

    Montpellier, 34295

  • Research Site

    Quimper, 29000

  • Research Site

    Reims, 51092

  • Research Site

    Villefranche-sur-Saône, 69655

Other trials in France

United Kingdom11 sites

  • Research Site

    Bradford, BD9 6RJ

  • Research Site

    Cottingham, HU16 5JQ

  • Research Site

    Glasgow, G4 0SF

  • Research Site

    Leeds, LS9 7TF

  • Research Site

    Liverpool, L7 8XP

  • Research Site

    London, EC1M 6BQ

  • Research Site

    London, NW3 2QG

  • Research Site

    Macclesfield, SK10 3BL

  • Research Site

    Newcastle upon Tyne, NE7 7AF

  • Research Site

    Portsmouth, PO6 3LY

  • Research Site

    Wakefield, WF1 4DG

Other trials in United Kingdom

Hungary10 sites

  • Research Site

    Budapest, 1203

  • Research Site

    Debrecen, 4032

  • Research Site

    Edelény, 3780

  • Research Site

    Encs, 3860

  • Research Site

    Gödöllő, 2100

  • Research Site

    Hajdúnánás, 4080

  • Research Site

    Mosonmagyaróvár, 9200

  • Research Site

    Pécs, 7635

  • Research Site

    Százhalombatta, 2440

  • Research Site

    Szolnok, 5000

Other trials in Hungary

South Korea10 sites

  • Research Site

    Anyang-si, 14068

  • Research Site

    Daegu, 42415

  • Research Site

    Incheon, 21565

  • Research Site

    Jeonju, 54907

  • Research Site

    Seoul, 04763

  • Research Site

    Seoul, 05030

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 06591

  • Research Site

    Seoul, 06973

  • Research Site

    Wŏnju, 26426

Other trials in South Korea

Canada9 sites

  • Research Site

    Ajax, Ontario, L1S 2J5

  • Research Site

    Burlington, Ontario, L7N 3V2

  • Research Site

    Calgary, Alberta, T3R 1W7

  • Research Site

    Kelowna, British Columbia, V1Y 4N7

  • Research Site

    Lévis, Quebec, G6V 0C9

  • Research Site

    Québec, Quebec, G1V 4G5

  • Research Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Research Site

    Toronto, Ontario, M5T 3A9

  • Research Site

    Winchester, Ontario, K0C 2K0

Other trials in Canada

Poland9 sites

  • Research Site

    Bialystok, 15-044

  • Research Site

    Bydgoszcz, 85-796

  • Research Site

    Chrzanów, 32-500

  • Research Site

    Kielce, 25-426

  • Research Site

    Krakow, 30-033

  • Research Site

    Krakow, 31-513

  • Research Site

    Płock, 09-407

  • Research Site

    Pruszków, 05-800

  • Research Site

    Rzeszów, 35-205

Other trials in Poland

Belgium8 sites

  • Research Site

    Brussels, 1070

  • Research Site

    Edegem, 2650

  • Research Site

    Ghent, 9000

  • Research Site

    Kortrijk, 8500

  • Research Site

    Leuven, 3000

  • Research Site

    Mechelen, 2800

  • Research Site

    Namur, 5101

  • Research Site

    Roeselare, 8800

Other trials in Belgium

Chile8 sites

  • Research Site

    Chile, 7770484

  • Research Site

    Concepción, 4070094

  • Research Site

    Quillota, 2260000

  • Research Site

    Santiago, 7500010

  • Research Site

    Santiago, 7501126

  • Research Site

    Santiago, 7750495

  • Research Site

    Santiago, 8380453

  • Research Site

    Viña del Mar, 2540488

Other trials in Chile

Italy8 sites

  • Research Site

    Cona, 44124

  • Research Site

    Foggia, 71100

  • Research Site

    Modena, 41124

  • Research Site

    Naples, 80131

  • Research Site

    Padua, 35128

  • Research Site

    Pavia, 27100

  • Research Site

    Pisa, 56100

  • Research Site

    Roma, 161

Other trials in Italy

Netherlands8 sites

  • Research Site

    's-Hertogenbosch, 5223 GZ

  • Research Site

    Arnhem, 6815 AD

  • Research Site

    Breda, 4818 CK

  • Research Site

    Heerlen, 6419 PC

  • Research Site

    Roermond, 6043 CV

  • Research Site

    Rotterdam, 3045 PM

  • Research Site

    Rotterdam, 3083 AN

  • Research Site

    Zutphen, 7207 AE

Other trials in Netherlands

Spain8 sites

  • Research Site

    Badalona(Barcelona), 08916

  • Research Site

    Barcelona, 08035

  • Research Site

    Cáceres, 10003

  • Research Site

    Madrid, 28850

  • Research Site

    Málaga, 29010

  • Research Site

    Mérida, 06800

  • Research Site

    Santander, 39008

  • Research Site

    Zaragoza, 50009

Other trials in Spain

Bulgaria7 sites

  • Research Site

    Dupnitsa, 2600

  • Research Site

    Haskovo, 6300

  • Research Site

    Panagyurishte, 4500

  • Research Site

    Plovdiv, 4003

  • Research Site

    Sofia, 1756

  • Research Site

    Veliko Tanovo, 5000

  • Research Site

    Yambol, 8600

Other trials in Bulgaria

Denmark7 sites

  • Research Site

    Aalborg, 9000

  • Research Site

    Aarhus, 8200

  • 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

Malaysia6 sites

  • Research Site

    Alor Star, 5460

  • Research Site

    Kajang, 43000

  • Research Site

    Kota Bharu, 15586

  • Research Site

    Kuala Lumpur, 59100

  • Research Site

    Kuantan, 25100

  • Research Site

    Seremban, 70300

Other trials in Malaysia

Thailand6 sites

  • Research Site

    Hat Yai, 90110

  • Research Site

    Khlong Luang, 12120

  • Research Site

    Muang, 22000

  • Research Site

    Muang, 40002

  • Research Site

    Mueang, 20000

  • Research Site

    Nakhon Ratchasima, 30000

Other trials in Thailand

Vietnam6 sites

  • Research Site

    Hà Nội, 100000

  • Research Site

    Hanoi, 100000

  • Research Site

    Hanoi, 10000

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Ho Chi Minh City, 70000

  • Research Site

    Hochiminh, 70000

Other trials in Vietnam

Peru5 sites

  • Research Site

    Lima, 15046

  • Research Site

    Lima, 15102

  • Research Site

    Lima, LIMA 21

  • Research Site

    Piura, 20001

  • Research Site

    Santa Beatriz, LIMA 14

Other trials in Peru

Greece4 sites

  • Research Site

    Athens, 11521

  • Research Site

    Athens, 17562

  • Research Site

    Heraklion, 71409

  • Research Site

    Thessaloniki, 57010

Other trials in Greece

Ireland4 sites

  • Research Site

    Cork, T12 DV56

  • Research Site

    Dublin, D24 NR0A

  • Research Site

    Galway, H91 YR71

  • Research Site

    Moneymore, A92 VW28

Other trials in Ireland

Turkey (Türkiye)3 sites

  • Research Site

    Adana, 1330

  • Research Site

    Istanbul, 34722

  • Research Site

    Mersin, 33343

Other trials in Turkey (Türkiye)

Mexico1 site

  • Research Site

    Mexico City, 03310

Other trials in Mexico

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 Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)

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

Being tested
Placebo, Tozorakimab
Keywords
Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, MEDI3506, exacerbations, ICS, LABA/LAMA, Biologic, Biologic Treatment
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.

  • PlaceboDrug

    Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.

  • TozorakimabDrug

    Administered subcutaneously tozorakimab and placebo throughout the study.

Study groups in NCT06040086
Study groupRoleWhat they receive
TozorakimabExperimentalDosing subcutaneously tozorakimab
Receives: Drug: Tozorakimab
PlaceboPlacebo comparatorDosing 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.

  1. Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.

    The primary endpoint will be assessed 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]).

    Measured: Over 52 weeks

Secondary outcomes (26)

  1. 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

  2. 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

  3. 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

  4. Annualized rate of severe COPD exacerbations in former smokers

    The rate ratio of severe COPD exacerbations will be assessed in former smokers.

    Measured: Variable duration period up to study completion, approximately 3 years

  5. Annualized rate of severe COPD exacerbations in former or current smokers

    The rate ratio of severe COPD exacerbations will be assessed in the overall population of current and former smokers.

    Measured: Variable duration period up to study completion, approximately 3 years

  6. 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

  7. Change from baseline in E-RS:COPD total score in former or current 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

  8. Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers

    Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers.

    Measured: Over 52 weeks

  9. Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers

    Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in the overall population of current and former smokers.

    Measured: Over 52 weeks

  10. Change from baseline in post-bronchodilator FEV1 (mL) in former smokers

    Change from baseline in post-bronchodilator FEV1 (mL) in former smokers.

    Measured: Week 52

  11. Change from baseline in post-bronchodilator FEV1 (mL) in former smokers or current smokers

    Change from baseline in post-bronchodilator FEV1 (mL) in former smokers or current smokers.

    Measured: Week 52

  12. Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former smokers

    The rate ratio of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former smokers.

    Measured: Variable duration period up to study completion, approximately 3 years

  13. Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former or current smokers

    The rate ratio of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former or current smokers.

    Measured: Variable duration period up to study completion, approximately 3 years

  14. Change from baseline in pre-BD, pre-dose trough FEV1 (mL)

    Change from baseline in pre-BD, pre-dose trough FEV1 (mL).

    Measured: 52 weeks

  15. Change from baseline in post-BD FEV1 (mL)

    Change from baseline in post-BD FEV1 (mL).

    Measured: Over 52 weeks

  16. Time to first moderate to severe COPD exacerbation

    Time to first moderate to severe COPD exacerbation compared with placebo.

    Measured: Over 52 weeks

  17. Time to first severe COPD exacerbation

    Time to first severe COPD exacerbation compared with placebo.

    Measured: Variable duration period up to study completion, approximately 3 years

  18. Change from baseline in CAT total score

    Change from baseline in CAT total score compared with placebo.

    Measured: Week 52

  19. Proportion of participants achieving MCID in CAT score

    Proportion of participants achieving MCID in CAT score (percentage of participants with a decrease in CAT total score of ≥ 2 points from baseline).

    Measured: Week 52

  20. Proportion of participants achieving MCID in SGRQ total score

    Proportion of participants achieving MCID in SGRQ score (percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline).

    Measured: Week 52

  21. Proportion of participants achieving MCID in E-RS:COPD total score

    Proportion of participants achieving MCID in E-RS:COPD total score (percentage of participants with a decrease in E-RS:COPD total score of ≥ 2 points from baseline).

    Measured: Week 52

  22. Annualized rate of healthcare resource utilization

    Annualized rate of healthcare resource utilization.

    Measured: Variable duration period up to study completion, approximately 3 years

  23. Change from baseline in rescue medication

    Change from baseline (difference in mean number of puffs/day) in rescue medication use.

    Measured: Over 52 weeks

  24. Trough serum concentrations of tozorakimab

    Pharmacokinetics: concentrations of tozorakimab in trough serum.

    Measured: Over 52 weeks

  25. Presence of anti-drug antibodies

    Immunogenicity: presence of tozorakimab anti-drug antibodies in blood serum.

    Measured: Over 52 weeks

  26. Time to death

    Time to death (all-cause mortality)

    Measured: Variable duration period up to study completion, approximately 3 years

Timeline

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

  1. First posted15 Sep 2023
  2. Study start22 Sep 2023
  3. Primary completion6 Mar 2026
  4. Study completion22 May 2026

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06040086
Sponsor's protocol ID
D9180C00012
Other IDs
2023-505543-39-00, 2023
Acronym
MIRANDA
Status last verified
Jul 2026
First submitted
25 Aug 2023
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • 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

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 368 sites in 29 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 20 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 368 sites in United States, China, Japan, Germany, Argentina and 24 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 NCT06040086, which also lists 1 linked publication.

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 24 Jul 2026.

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