Efficacy and Safety of PF-07275315 Compared with Placebo in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

The study involves adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long‑term breathing problem that makes it hard to get enough air in and out of the lungs. The investigational medicine, identified as PF-07275315, is given as a small liquid injection under the skin (subcutaneous administration). Some participants will receive a matching placebo, which looks the same but does not contain the active drug.

The purpose of the study is to evaluate the safety and effectiveness of the new medicine compared with placebo in people with this condition. Participants will be randomly assigned to receive either the study drug or placebo, and neither they nor the study staff will know which treatment is given (double‑blind design). Over several months, participants will attend regular clinic visits where simple breathing tests, such as measuring the amount of air forced out in one second (FEV1), and questionnaires about symptoms will be done, while safety checks such as blood tests and heart rhythm monitoring are performed. The study will track how often breathing worsening events, called exacerbations, occur and will record any side effects.

1 baseline assessments and enrollment confirmation

after you agree to join the study, a study staff member will confirm your enrollment and record your personal information.

you will undergo baseline measurements, which include a breathing test called fev1 (forced expiratory volume in one second), a lung capacity test called fvc (forced vital capacity), and other routine health checks such as blood pressure, heart rhythm (ecg), and laboratory tests.

2 randomization to study medication or placebo

based on a computer‑generated schedule, you will be assigned either the study drug pf-07275315 or a matching placebo. the assignment is double‑blind, meaning neither you nor the study staff will know which you receive.

3 first subcutaneous injection

the assigned product will be given as a subcutaneous injection (injection under the skin) using a sterile solution for injection.

the label on the product indicates a dose of 0 mg; the exact amount you receive is defined by the study protocol and will be the same at each scheduled administration.

4 regular follow‑up visits and repeat injections

you will return to the study site at scheduled intervals. during phase 2, visits occur up to week 24; during phase 3, visits continue up to week 52.

at each visit you will receive another subcutaneous injection of the same product, undergo repeat fev1 and fvc measurements, and have vital signs and safety labs checked.

the study staff will ask about any worsening of breathing problems, known as exacerbations, and record any side effects.

5 questionnaire completion

at specified weeks (for example week 12 and week 52 in phase 3) you will complete questionnaires that evaluate your breathing health, such as the sgrq (Saint George’s Respiratory Questionnaire), the cat (COPD assessment test), and the e‑rs:copd (Evaluating Respiratory Symptoms in COPD).

these forms help measure changes in symptoms over time.

6 continuous safety monitoring

throughout the study you will be asked to report any new medical problems, especially those that start after you begin the medication. these are called treatment‑emergent adverse events (teae).

serious adverse events (sae) that require hospitalization or lead to discontinuation will be recorded immediately.

7 final study visit and end of treatment

at the end of the treatment period (week 24 for phase 2 or week 52 for phase 3) you will have a final visit that includes the same breathing tests, questionnaires, and safety assessments performed at baseline.

after the final assessments, the study medication will be stopped and you will be advised on any further care needed.

Who Can Join the Study?

Be between 35 and 80 years old at the time of the screening visit; if you could become pregnant, you must agree to use a highly effective birth‑control method.
Have a diagnosis of COPD (chronic obstructive pulmonary disease) for at least one year, confirmed using the current GOLD guidelines (a worldwide standard for defining COPD).
Show specific lung‑function results after using a medication that opens the airways (bronchodilator): the ratio of FEV1 (the amount of air you can forcefully exhale in one second) to FVC (the total amount of air you can exhale) must be less than 0.7, and your FEV1 must be between 30 % and 70 % of what is predicted for a healthy person of your age, sex, and size.
Score at least 15 on the CAT questionnaire (a short survey that measures how COPD affects you) at any pre‑randomization visit, and all CAT scores must be greater than 10.
Have a blood eosinophil count of at least 150 cells per microliter on one of the screening visits (eosinophils are a type of white blood cell that can affect how you respond to certain COPD medicines).
Be continuously treated with standard COPD therapy (SOC therapy) that includes three medicines together: a LABA (long‑acting beta‑agonist), a LAMA (long‑acting muscarinic antagonist), and an ICS (inhaled corticosteroid) for at least six months, and the dose must have been stable for at least three months. If an inhaled steroid cannot be used, a combination of LABA + LAMA alone is acceptable.
Be a current smoker or a former smoker with a history of at least 10 pack‑years (the equivalent of smoking one pack per day for ten years). Former smokers must have not used any tobacco product for at least six months before the first visit. Only cigarette smoking counts; cigars, pipes, chewing tobacco, vaping, or similar products are not considered.
Have had at least two moderate or severe COPD exacerbations (worsening of symptoms) in the past 12 months, with at least one treated with oral or injectable systemic corticosteroids and at least one occurring while you were on triple therapy (LABA + LAMA + ICS). A moderate exacerbation requires steroids and/or antibiotics for at least three days; a severe exacerbation requires a hospital stay or a stay in an emergency/urgent‑care setting for 24 hours or more.
Have a body mass index (BMI) between 18 and 40 kg/m² (a measure that relates weight to height).

Who Cannot Join the Study?

Evidence of extensive emphysema (about 25% or more of one side of the chest filled with damaged air spaces) within the past 24 months.
Any significant eye inflammation such as conjunctivitis or other surface eye changes.
Any infection that required treatment with antiviral, antibacterial, antifungal, antiparasitic, or antiprotozoal medicines within the 4 weeks before screening.
History of having a whole lung removed (pneumonectomy) or part of a lung removed (wedge or lobectomy), or having lung‑volume‑reduction surgery within the past 12 months or planning such surgery during the study.
Starting a pulmonary rehabilitation program within the past 6 months or planning to start one during the study (being in the maintenance phase of an existing program is allowed).
Certain heart rhythm problems, including intermittent (paroxysmal) atrial fibrillation (irregular heartbeat). Persistent atrial fibrillation that is well‑controlled may be allowed, but other serious arrhythmias are excluded.
Serious heart disease such as acute or severe left‑hand heart failure, heart failure with preserved ejection fraction (HFpEF), or cor pulmonale (right‑hand heart failure caused by lung disease).
Any other medical or psychiatric condition, or any laboratory abnormality, that could increase the risk of taking part in the study or that the investigator judges makes participation unsuitable.
Use of any prohibited medication, or inability or unwillingness to take required study medications.
For Phase 3 only: having already taken part in Phase 2 of this same study, whether completed or stopped early.
Prior or current treatment with approved or experimental biologic drugs (such as inhibitors of IL‑4Rα, TSLP, IL‑5) for type 2 inflammatory diseases like eczema, eosinophilic esophagitis, or chronic sinusitis.
Significant chronic lung disease other than COPD, including lung fibrosis, interstitial lung disease, lung cancer, sarcoidosis, cystic fibrosis, extensive bronchiectasis, pulmonary hypertension, certain vasculitis (e.g., eosinophilic granulomatosis with polyangiitis), α‑1 antitrypsin deficiency, or a history of asthma or asthma‑COPD overlap.
History of a severe allergic reaction (anaphylaxis) to any antibody therapy, to PF‑07275315, or to any ingredient of the study drug.
Receiving any investigational drug or vaccine within 30 days (or longer, depending on the drug’s half‑life) before the screening visit.
Laboratory test results that fall outside safe ranges, such as:
- Total bilirubin ≥ 1.5 × upper limit of normal (or direct bilirubin > upper limit for Gilbert’s syndrome),
- AST or ALT (liver enzymes) ≥ 2.5 × upper limit of normal,
- Absolute neutrophil count ≤ 1500 cells/mm³,
- Platelets ≤ 100,000/mm³,
- Hemoglobin ≤ 9.0 g/dL (women) or ≤ 10.0 g/dL (men),
- Active or latent tuberculosis,
- Active or latent HIV, hepatitis B, or hepatitis C.
Baseline 12‑lead ECG (heart electrical test) showing clinically relevant abnormalities, such as QTcF > 450 ms, complete left bundle‑branch block, signs of a heart attack, serious heart block, or dangerous fast or slow heart rhythms.
Failure to complete at least 4 out of 7 days (about 57%) of the symptom diary or medication‑use log during the screening period, indicating inability or unwillingness to follow study procedures.
Being a study staff member, a family member of study staff, a sponsor employee directly involved in the study, or any of their family members.
Being currently pregnant, breastfeeding, or planning to become pregnant during the study.
Having pulmonary arterial hypertension (high blood pressure in the lung arteries) caused by COPD.
Chronic respiratory failure with high carbon‑dioxide levels that requires non‑invasive ventilatory support such as BiPAP.
Needing continuous oxygen therapy greater than 4 L/min by nasal cannula (or equivalent device) for more than 12 hours per day, or needing high‑flow or non‑rebreathing masks.
Low oxygen level at rest (SpO₂ < 88 %) while breathing normal air (or the participant’s usual oxygen level).
Severe sleep apnea that requires BiPAP or is associated with significant pulmonary hypertension.
Autoimmune or autoinflammatory diseases that require systemic immunosuppressive or immunomodulating medicines.
Recent COPD flare‑up, upper or lower respiratory infection, pneumonia, or hospital stay for a COPD exacerbation lasting 24 hours or more within the 4 weeks before screening.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopitaux Universitaires Paris Centre-Hopital Cochin	Paris	France
Medical Center FAMA Medical Ltd.	Plovdiv	Bulgaria
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Diamond Clinic Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD	Sofia	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD	Veliko Tirnovo	Bulgaria
MUDr. I. Cierna Peterova s.r.o.	Brandys Nad Labem	Czechia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
General University Hospital Of Patras	Patras	Greece
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Hospital Vithas Xanit Internacional	Benalmadena	Spain
Koch Robert Korhaz Es Rendelointezet	Edeleny	Hungary
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Klifeck GmbH	Delitzsch	Germany
Pro Familia Altera Sp. z o.o.	Katowice	Poland
Medizentrum Essen Borbeck	Essen	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
POIS Sachsen GmbH	Leipzig	Germany
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak	Grodzisk Mazowiecki	Poland
Hospital De Merida	Merida	Spain
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse	Ruse	Bulgaria
Erzsebet Gondozohaz Kft.	Godollo	Hungary
Medical Center Pulmo-2018 EOOD	Haskovo	Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD	Dimitrovgrad	Bulgaria
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Infer-Med Kft.	Pecs	Hungary
MEDICON a.s.	Prague	Czechia
Medical Center New Rehabilitation Center EOOD	Stara Zagora	Bulgaria
Centermed Sp. z o.o.	Lublin	Poland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Centrum Medyczne Pratia Katowice	Katowice	Poland
MICHAŁ BOGACKI DOBROSTAN	Wroclaw	Poland
Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Poland
Klinische Studien Pankow	Berlin	Germany
Szalay Janos Rendelointezet	Hajdunanas	Hungary
Odpxtguw ngcnhdgyi Mlutn Bhyofzvj amqb nxwgnofsf Snlyvqpeyqcwv knynd	Mlada Boleslav	Czechia
Cyj Cjras Rfrslatfges	Lyon	France
Ochzkemfm Eqlsky Kvek	Mosonmagyaróvár	Hungary
Liljh Geasdgk Htgbsvnp Ok Aceixw	Athens	Greece
Mtvstvo Cbjuwp Prntskpxeet Lvoh	Sofia	Bulgaria
Pzkigu Rvwzvlkkxbv Hocyla Svwh	Barcelona	Spain
Spdxndazkyu Hmfrpfyp Flc Aokult Tjcmhhkpz Og Puqznhpvh Dknzrfts Phznzx Eeqd	Pernik	Bulgaria
Pgjbjwqrqas Vjgpwcuho swewsj	Varnsdorf	Czechia
Ovvdccqh cwvsln pzuinfua sinaxk	Prague	Czechia
Ksfh Geva	Bendorf	Germany
Cgq danebkgaimrsbt	Epagny Metz Tessy	France
Pabvyz Gnjdjuee Gozasu Mpecfdc Ktunyxxy sahq	Sosnowiec	Poland
Aoodqek Uqi Igatk De Rjiyhz Eqloov	Reggio Emilia	Italy
Abdinpm Otvofdldpob Phhg Gmxqgrub Xwytx	Bergamo	Italy
Ubnrpstcul Drxgw Swtdw Dx Rjam Lm Sstfusoz	Rome	Italy
Hxgazuxl Uhbaxuugfpnlq Mieeicv Db Vtglkxqlxi	Santander	Spain
Olwcdjmdzmxx Civigpz Musdeyie Aqhn Osxek Crpmwv Kchknqnjq Cxqxsr sgzc	Ostrowiec Swietokrzyski	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	24.07.2026
Czechia	Not yet recruiting	24.07.2026
France	Not yet recruiting	24.07.2026
Germany	Not yet recruiting	24.07.2026
Greece	Not yet recruiting	24.07.2026
Hungary	Not yet recruiting	24.07.2026
Italy	Not yet recruiting	24.07.2026
Poland	Not yet recruiting	24.07.2026
Spain	Not yet recruiting	24.07.2026

Trial locations

PF-07275315 is an experimental medicine being studied for people with moderate‑to‑severe chronic obstructive pulmonary disease (COPD). It is given as a liquid that is injected just under the skin. Researchers hope that this medicine can improve breathing, reduce COPD symptoms such as shortness of breath and coughing, and possibly lower the number of flare‑ups. The trial is testing whether PF‑07275315 works better than a placebo in helping participants feel better and stay healthier.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) – Chronic obstructive pulmonary disease (COPD) is a long‑term lung condition that makes it hard to breathe. It is characterized by narrowed airways and damage to the lung tissue, which reduces airflow. Over time the breathing difficulty usually gets worse, especially during physical activity. People may notice a persistent cough, increased mucus production, and shortness of breath. The disease often progresses in stages, moving from mild to moderate and then to more severe forms as the lungs lose more function.

Trial ID:

2024-518587-12-00

Protocol code:

C4531031

Trial Phase:

Therapeutic exploratory (Phase II)

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Efficacy and Safety of PF-07275315 Compared with Placebo in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?