| CTRI Number |
CTRI/2026/04/109149 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Phase 2/3 Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
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An Interventional Phase 2/3, Randomized, Double-Blind, Third Party-Unblinded, Placebo- Controlled, Parallel-Group Study to Investigate Efficacy and Safety of PF-07275315 in Adult Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT07363694 |
ClinicalTrials.gov |
| Protocol C4531031, Protocol Amendment 1, 23 October 2025 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
912266932000 |
| Fax |
912226540274 |
| Email |
Seema.Pai@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
912266932000 |
| Fax |
912226540274 |
| Email |
Seema.Pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, United States |
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Primary Sponsor
|
| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East, New York, NY 10001, United States |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400 051. |
|
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Countries of Recruitment
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Argentina
Australia
Belgium
Bulgaria
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hungary
India
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Slovakia
Spain
Taiwan
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Hadda |
All India Institute of Medical Sciences |
3rd Floor, Porta-Cabin, New Private Ward Block, Department of Pulmonary, Critical Care & Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029, India
New Delhi
DELHI |
98688 83208
vijayhadda@yahoo.com |
| Dr Ajay Godse |
Bhaktivedanta Hospital and Research Institute |
3rd floor, Vrindavan Building, Medical Research Department, Bhaktivedanta Hospital and Research Institute, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road (East) Thane - 401107
Thane
MAHARASHTRA |
9820452037
drajaygodse@gmail.com |
| Dr Srikanth Krishnamurthy |
Hindusthan Hospital |
522/3, 523/3, Nava India Road, Udaiyampalayam, Coimbatore - 641028, Tamil Nadu, India
Coimbatore
TAMIL NADU |
9894257706
drsrikanthcbe@gmail.com |
| Dr Piyush Arora |
Jawahar Lal Nehru Medical College |
Kala Bagh, Ajmer 305001, Rajasthan,
Ajmer
RAJASTHAN |
7976496694
doctor.piyusharora@gmail.com |
| Dr Ravindra Reddy Etikala |
Kamineni Hospitals Private Limited |
Department of Pulmonology, Room No. 2, Basement Floor, Kamineni Hospitals Private Limited, Sy. No. 68, Inner Ring Road, L. B. Nagar, Hyderabad - 500068, Telangana, India
Hyderabad
TELANGANA |
9848023703
rvndrreddy@yahoo.com |
| Dr Jyothi Hattiholi |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
OPD No.18, First Floor, KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA |
9164012011
pulmojyoti@gmail.com |
| Dr Manish Jain |
Maharaja Agrasen Superspeciality Hospital |
7 Central Spine Road, Jaipur 302039, Rajasthan, India
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Jaydip Deb |
Nil Ratan Sircar Medical College and Hospital |
138, Acharya Jagadish Chandra Bose Road, Kolkata - 700014, West Bengal, India.
Kolkata
WEST BENGAL |
9830439804
jaydip.deb@gmail.com |
| Dr Jagdish Rawat |
Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital, |
Patel Nagar, Dehradun , 248001, Uttarakhand, India
Dehradun
UTTARANCHAL |
9639212630
drjagdishrawat254@gmail.com |
| Dr Amit Dhamija |
Sir Ganga Ram Hospital |
SGRH Marg, Rajinder Nagar, New Delhi - 110060, India
New Delhi
DELHI |
9811684520
dhamijaamit09@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee, Bhaktivedanta HEC office |
Approved |
| Ethics Committee, N.R.S. Medical College |
Submittted/Under Review |
| IEC, KLE Universitys KLE Dr PK Hospital & MRC |
Approved |
| Institutional Ethics Committee (IEC), Maharaja Agrasen Hospital Superspeciality Hospital |
Approved |
| Institutional Ethics Committee All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, SGRR Institute of Medical Health Sciences |
Approved |
| Institutional Human Ethics Committee Hindusthan Hospital |
Submittted/Under Review |
| Kamineni Institutional Ethics Committee, Kamineni Hospitals Private Limited |
Submittted/Under Review |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PF-07275315 |
Phase 2
Dose 1: PF-07275315 800 mg Loading Dose administered subcutaneously on Day 1, followed by PF- 07275315 400 mg Maintenance Dose administered subcutaneously every 4 weeks
Dose 2: PF-07275315 400 mg Loading Dose administered subcutaneously on Day 1, followed by PF- 07275315 200 mg administered subcutaneously every 4 weeks
Phase 3
PF-07275315 either dose from Phase 2 (to be determined): Loading Dose administered subcutaneously on Day 1, followed by Maintenance Dose
administered subcutaneously every 4 weeks
|
| Comparator Agent |
Plavebo |
Placebo Subcutaneously administered on Day 1, followed by administered SC Q4W |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
2. Spirometry values (post-bronchodilator forced expiratory volume in 1 second [FEV1] per forced vital capacity [FVC] less than 70 percent and post-bronchodilator FEV1 percent predicted less than 70 percent, but greater than equal to 30 percent).
3. Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for greater than equal to 6 months prior to Screening Visit 1 and at a stable dose for greater than equal to 3 months
4. Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening. |
|
| ExclusionCriteria |
| Details |
1. Significant pulmonary disease other than COPD.
2. Requirement for continuous chronic treatment with oxygen at greater than 4.0 liters per minute by nasal cannula or equivalent.
- Hypoxemia with a resting SpO2 less than 88 percent while breathing ambient air (or on the participants usual level of oxygen supplementation).
- Clinically significant cardiovascular disease, acute and or severe left heart failure, or heart failure partial ejection fraction, and or cor pulmonale. |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Phase 3 part: Annualized rate of moderate or severe ECOPD
|
Phase 2 part: Baseline to Week 24
Phase 3 part: Baseline to Week 52 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Phase 2: Annualized rate of moderate or severe ECOPD. |
Baseline to Week 24 |
| Phase 2: Change from baseline in pre-BD FEV1 up to Week 24. |
Baseline to Week 24 |
| Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 |
Baseline to Week 24 |
| Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24. |
Baseline to Week 24 |
| Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24. |
Baseline to Week 24 |
| Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study. |
Baseline to Week 24 |
| Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation. |
Baseline to Week 24 |
| Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. |
Baseline to Week 24 |
| Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52. |
Baseline to Week 52 |
| Phase 3: Annualized rate of severe ECOPD. |
Baseline to Week 52 |
| Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. |
Baseline to Week 24 |
| Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization. |
Baseline to Week 52 |
|
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Target Sample Size
|
Total Sample Size="1056"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="5"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who- - Are 35 to 80 years old
- Have had moderate-to-severe COPD for at least 12 months
- Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months
- Have been continuously taking their regular maintenance treatment for COPD over at least 6 months at a stable dose for 3 months
All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic. Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic. |