Active Studies

1. Patient 40 Years or Older at the time of signed informed consent
2. IPF diagnosis:
   a. Satisfying the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Latin American Thoracic Association(ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the investigator
   b. UIP or probable UIP based on chest HRCT obtained within 12 months of Day 0, or historical lung biopsy consistent with UIP
3. If receiving antifibrotic agents pirfenidone or nintedanib, patients must be receiving a stable dose for > 2 months prior to Day 0 and planning to stay on stable background
   therapy; if not receiving pirfenidone or nintedanib, patients must be naive to both drugs or not have received either for at least four weeks prior to Day 0 and remain off
   background therapy with no intention to start or re-start. (combination of nintedanib and pirfenidone not allowed)
4. If receiving monotherapy for the treatment of pulmonary hypertension (eg, phosphodiesterase 5 inhibitors, endothelin receptor antagonists, or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for > 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study
5. FVC > 40% of predicted normal according to Global Lung Initiative
6. DLCO (corrected for hemoglobin) > 25% to <80% of predicted normal
7. ACQ-5 score ≥1.5 at screening (visit 1)

1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70%[FEV1/FVC <0.7])
2. Known significant PAH, defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing a cardiac
   index >2 L/min/m, or PAH requiring combination of PAH-specific therapies or any PAH parenteral therapy.
3. Emphysema > 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent chest HRCT.
4. Acute IPF exacerbation within six weeks prior to screening and/or during the screening period (investigator-determined).
5. Lower respiratory tract infection requiring antibiotics within four weeks prior to Day 0 and/or during the screening period.
6. Major surgery (major according to the investigator’s assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list
   is allowed).
7. Underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment).
8. Cardiovascular diseases, and of the following:
   a. Severe hypertension, uncontrolled despite treatment (>160/100 mmHg)
   b. Myocardial infarction within six months of Day 0
   c. Unstable cardiac angina
9. Bleeding risk, any of the following:
   a. Known genetic predisposition to bleeding
   b. Patients who require:
   i. Fibrinolysis, full-dose therapeutic anticoagulation
   ii. High dose antiplatelet therapy
10. Use of systemic corticosteroids equivalent to prednisone > 15mg/day within two weeks of Day 0
11. Any documented active or suspected malignancy or history of malignancy within five years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ
    squamous cell carcinoma of the skin, in situ carcinoma of uterine cervix or “under surveillance” prostate cancer.
12. Evidence of active infection based on clinical exam or laboratory findings

1. Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
2. Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
4. Pre-bronchodilator FEV1, as defined in the protocol
5. Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol
6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
7. ACQ-5 score ≥1.5 at screening (visit 1)
8. History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
9. Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol

1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
2. Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging [MRI]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)
3. A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol
4. Weight is less than 30 kilograms
5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
6. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol
7. Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period

1. Males and females at least 18 years of age who give voluntary written informed consent to participate in the study.
2. Patients with a diagnosis of ILD based on computed tomography imaging, including:
   • Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
   • Connective tissue disease-associated ILD with FVC <70%
   • Hypersensitivity pneumonitis
   • Scleroderma-related ILD
   • Autoimmune ILD
   • Nonspecific interstitial pneumonia
   • Occupational lung disease
   • Combined pulmonary fibrosis and emphysema
3. Patients must meet a total of 2 or more criteria from at least 2 distinct categories below (ie, Category 1, Category 2, Category 3) based on the Investigator’s clinical judgment, within 180 days of Screening.

Category 1: Clinical tests

a. PFTs with at least 1 of the following results:

• DLCO <40%
• DLCO decline of ≥15% based on 2 most recent assessments
• Worsening DLCO (decline >10%) with stable FVC (decline <5%) (ie, worsening FVC/DLCO ratio) based on 2 most recent assessments

b. Historical HRCT with any of the following findings:

• Right ventricle enlargement: RV:LV ratio >1
• Pulmonary artery enlargement
• Pulmonary artery/aorta ratio >1.0
• Ventricular septal flattening
• Enlarged pulmonary arteries in the lung periphery

Category 2: Symptoms, oxygenation, exercise capacity, and BNP/NT-proBNP

• Symptoms disproportionate to ILD severity or changes in symptoms not explained by ILD progression
• Desaturation on 6MWT disproportionate to ILD severity in the opinion of the Investigator
• 6-Minute Walk Distance decline of ≥15% based on 2 more recent assessments
• Worsening desaturation requiring more supplemental oxygen
• Recent worsening desaturation
• BNP >200 pg/mL or NT-proBNP >395 pg/mL
• Physical exam findings (at least 1 of the following): syncope, jugular venous distension, ankle swelling/peripheral edema, ascites, loud P2 or S2 heart sound, or hepatomegaly

Category 3: Echocardiography

• RV systolic pressure >35 mmHg
• Any RV dilation or enlargement
• Other RV abnormalities in the clinician’s judgment
• Tricuspid annular plane systolic excursion <2 cm

Patients are excluded from the study if any of the following criteria apply:

1. Prior RHC with mPAP >20 mmHg
2. Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension medication
3. Diagnosed with chronic obstructive pulmonary disease
4. Uncontrolled or untreated sleep apnea
5. Pulmonary embolism within the past 3 months
6. History of ischemic heart disease or left-sided myocardial dysfunction within 12 months of Screening, defined as LV ejection fraction <40% or pulmonary capillary wedge pressure >15 mmHg
7. Any other clinical features that, in the opinion of the Investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for RHC

1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
2. Documented diagnosis of SSc as defined by the American College of Rheumatology classification criteria
3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1
4. Total mRSS >15 on Day 1
5. Evidence of interstitial lung disease on centrally read screening HRCT
6. Anticentromere antibodynegative on central test at screening
7. Evidence for active or progressive disease, defined by at least one of the following criteria
   • Disease duration <24 month on Day 1
   • Disease duration >24 months but <5 years on Day 1 AND one of the following
     • Anti-topoisomerase I antibody positive on central test at screening, OR
     • Absolute decline in FVC >5% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
     • Absolute decline in DLco >10% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
     • Progressive ILD on HRCT, as assessed by the investigator comparing the screening scan and a previous scan done within 12 months prior to screening.
   • Disease duration >5 but <7 years on Day 1 AND anti-topoisomerase I antibody positive on central test at screening, AND one of the following:
     • Absolute decline in FVC >5% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
     • Absolute decline in DLco >10% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
     • Progressive ILD on HRCT, as assessed by the investigator comparing the screening scan and a previous scan done within 12 months prior to screening.
8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh
9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study
10. Female participants eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
    • Is a WONCBP
    • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 4 months after the last dose of study intervention.

    A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

    • If a urine test cannot be confirmed as negative, a serum pregnancy test is required
11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

1. Systemic sclerosis-like illness, including but not limited to localized scleroderma, eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions, scleroderma-like conditions that are associated with environmental chemical and drug exposure
2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren’s syndrome, antisynthetase syndrome, or mixed connective tissue disease
3. FVC <45% of predicted, or a DLco <40% of predicted or requiring supplemental oxygen at screening
4. Pulmonary arterial hypertension prior to first day of dosing
5. SSc renal crisis within 6 months prior to the first day of dosing
6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
7. Obstructive pulmonary disease
8. Significant emphysema on screening HRCT
9. Significant allergies to human or murine proteins, humanized monoclonal antibodies, or contrast agents
10. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
11. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
12. Breast cancer within the past 10 years
13. ALT>2 x ULN
14. Total bilirubin >1.5 x ULN
15. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
16. QTc >450 msec or QTc >480 msec in participants with bundle branch block
17. Major surgery within 3 month prior to screening or planned during the duration of the study
18. An active infection, or a history of infections as follows:
    • History of opportunistic infections that have not resolved by 6 month prior to the first day of dosing or recurrent infection as determined by the investigator
    • A serious infection requiring treatment with IV antibiotics and/or hospitalization, if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing
    • An acute or chronic infection requiring treatment with oral antibiotics or antiviral medications, if the last doe was received within 30 days of the first day of dosing. Prophylactic anti-infective treatment is allowed
    • Any active or unresolved bacterial, viral or fungal infection present on the first day of dosing, whether requiring treatment or not. This does not include fungal nail infections
    • Active or past osteomyelitis, unless fully resolved in the opinion of the investigator
19. Symptomatic herpes zoster within 3 month prior to screening
20. Evidence of active or latent TB as documented by medical history and examination, chest X-rays, and TB testing: either a positive TST or a positive TB test such as QuantiFERON-TB Gold Plus test
21. Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms
22. Have evidence of serious current suicide risk, defined as PHQ-9 score >10, or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator’s judgment, poses a significant suicide risk
23. Previous or planned major organ transplant or bone marrow transplant
24. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 month or 5 half-lives (whichever is longer) prior to dosing
25. Treatment with rituximab within 6 months prior to Day 1
26. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine within 3 months prior to Day 1
27. Treatment with cyclophosphamide within 6 months prior to Day 1
28. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors within 4 weeks prior to Day 1
29. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1
30. Treatment with IM or IV corticosteroids within 1 month prior to Day 1

• Participant must be ≥40 years of age at the time of signing the informed consent.
• Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
• Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit 2.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12months prior to screening.
• Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
• CAT score ≥ 10 at Visit 1.
• Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
• Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
• Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

• Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
• Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
• Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
• Significant left heart failure.
• Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
• Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
• History of another underlying condition that predisposes the participant to infections.
• History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
• Abnormal laboratory findings.
• Participants with evidence of active liver disease and/or evidence of chronic liver disease.
• Participants with history of HIV infection or who test positive for HIV.
• History of lung volume reduction surgery.
• Current or history of malignancy within 5 years before the screening visit.

1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
   • For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
   • For Study ACT18301: LABA with or without LTRA
3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
4. Contraception for male and female participants For female participants:
   • must agree to use contraception/barrier
   • not pregnant or breast feeding
   • no eggs donation or cryopreserving eggs
5. For male participants:
   • No sperm donation or cryopreserving sperm
6. Capable of giving signed informed consent

Participants are excluded from the study if any of the following criteria apply:

1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
2. Participant who was diagnosed with a new pulmonary disease which may impair lung function
3. Current smoker or active vaping of any products and/or marijuana smoking
4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
6. Participants who are receiving prohibited concomitant medications
7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
8. Concurrent participation in any other clinical study, including non-interventional studies
9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.

• Adult, both sexes, aged ≥ 40 years.
• Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.
• Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or > 40 kg (female). Checked at V1 and V2.
• Patient has a CIG smoking history ≥ 10 years.
• Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2.
• Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2.
• Patient agrees to be randomized into one of the two study arms. Checked at V2.
• Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC <70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 < 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for > three months a year for the two consecutive years prior to the screening visit). Checked at V2.
• Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.)

• Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
• Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.
• Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.
• Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.
• Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2.
• Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read).
• Patient with a history of asthma.
• Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).
• Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.
• Patient with active or history of alcohol and/or drug abuse within the past year.
• Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C).
• Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.
• Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion.
• Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.
• Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2.
• Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.
• Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2.
• Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.

• Physician-diagnosed asthma with duration of ≥12 months.
• Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
• Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
• For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
• Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
• Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
• Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
• FEV1 ≥30% predicted.

• Regular use of immunosuppressive medication.
• Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
• Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
• COPD and other clinically significant pulmonary disease other than asthma.
• Known or suspected history of immunosuppression.
• History of known immunodeficiency disorder or hepatitis B or C.
• History of alcohol abuse and/or drug abuse.
• Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy.
• Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
• Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
• Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
• Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
• Participants that have been recently treated with bronchial thermoplasty.
• Recent treatment with OCS and/or hospitalization for an exacerbation of asthma.
• Recent receipt of any investigational nonbiologic drug.
• A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population.

• Physician-diagnosed COPD with duration of ≥12 months.
• Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
• Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
• Current or former smoker with a history of smoking of ≥10 pack-years.
• Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
• Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
• Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.

• Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
• Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
• Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results
• Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
• Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit.
• Known or suspected history of immunosuppression.
• History of known immunodeficiency disorder or hepatitis B or C.
• History of alcohol abuse and/or drug abuse.
• Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
• Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day.
• Participants on long-term macrolide.
• Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening.
• A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
• Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
• Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
• Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
• Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
• Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.