Moderate to Severe Chronic Obstructive Pulmonary DiseasePhase 3NCT07839884
A Continuation Study of Tilrekimig in Adults With Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About This Medicine When Used for a Long Period of Time
A Phase 3 study testing Tilrekimig in people with Moderate to Severe Chronic Obstructive Pulmonary Disease, run by Pfizer.
Trial summary
A Continuation Study of Tilrekimig in Adults with Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About this Medicine when Used for a Long Period of Time. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Moderate to Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- Tilrekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 12 May 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who completed parent study C4531031.
- Individuals of childbearing potential must be willing to use a highly effective method of contraception.
Who cannot join
- Ongoing safety-significant AE.
- Parent-study SAE incompatible with continued participation.
- Medical, laboratory, psychiatric, or behavioral condition that increases risk or interferes with study participation.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF TILREKIMIG IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
A Continuation Study of Tilrekimig in Adults with Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About this Medicine when Used for a Long Period of Time.
Read the detailed description
C4531015 is a multicenter, open-label extension study designed to evaluate the longer-term safety and tolerability of tilrekimig in eligible participants with chronic obstructive pulmonary disease (COPD) who have participated in and completed the applicable requirements of the parent study, C4531031.
Participants who complete the protocol-defined parent-study period may be considered for enrollment in C4531015. Before entering the extension study, participants must provide informed consent, satisfy all C4531015 eligibility criteria, and be considered appropriate for continued study treatment by the investigator. Participation in C4531031 does not automatically establish eligibility for the extension study.
All enrolled participants will receive open-label tilrekimig according to the dose, route of administration, and treatment schedule specified in the C4531015 protocol. Participants may continue protocol-permitted background COPD maintenance therapy. Use of concomitant and rescue medications will be managed according to the protocol.
The study will primarily characterize the safety and tolerability of longer-term exposure to tilrekimig. Safety monitoring will include the collection of adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment interruption or discontinuation, and other protocol-defined safety events. Participants will also undergo clinical laboratory testing, vital-sign assessments, physical examinations, and other safety evaluations at scheduled study visits.
Additional protocol-defined assessments may be conducted to characterize COPD-related clinical outcomes and the effects of continued treatment. These may include evaluation of COPD exacerbations, respiratory symptoms, lung function, health status, participant-reported outcomes (PROs), healthcare resource utilization, pharmacokinetics (PK), immunogenicity, biomarkers, or other exploratory measures, as applicable. These assessments are intended to provide supportive information and should not be interpreted as demonstrating that tilrekimig is safe or effective.
Participants will attend study visits according to the protocol Schedule of Activities (SoA). At these visits, investigators will assess continued eligibility, treatment adherence, changes in health status, AEs, concomitant medications, COPD-related events, and the results of required clinical and laboratory evaluations.
Participants may discontinue study intervention because of an AE, pregnancy, use of prohibited medication, lack of compliance with protocol requirements, an investigator or sponsor decision, withdrawal of consent, or another protocol-defined reason. Participants who discontinue study intervention may be asked to complete applicable early-discontinuation and safety follow-up assessments.
The study may provide eligible participants transitioning from C4531031 with continued access to investigational treatment while allowing additional safety and clinical information to be collected over a longer treatment period. Tilrekimig remains investigational, and participation in the study does not guarantee that an individual participant will experience clinical benefit.
- Being tested
- Tilrekimig
- Keywords
- COPD
- 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.
TilrekimigDrug
Also called PF-07275315
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Tilrekimig (PF-07275315) | Experimental | Tilrekimig (PF-07275315) subcutaneous injection (sc) Receives: Drug: Tilrekimig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
Number and percentage of participants with treatment-emergent adverse events. An adverse event is considered treatment-emergent if it begins or increases in severity following initiation of study intervention. Events will be summarized by severity and other protocol-defined characteristics
Measured: Up to 60 weeks
Number of Participants With Treatment-Emergent Serious Adverse Events During Treatment Period 1
Number and percentage of participants with treatment-emergent serious adverse events. Serious adverse events are events that meet one or more of the protocol-defined seriousness criteria.
Measured: Up to 60 weeks
Number of Participants With Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Intervention During Treatment Period 1
Number and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.
Measured: Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During Treatment Period 1
Number and percentage of participants with protocol-defined clinical abnormalities in laboratory values and vitals signs. Laboratory assessments include protocol-required hematology and blood chemistry evaluations. Abnormal laboratory findings will be evaluated according to protocol-defined criteria and investigator assessment of clinical significance. Vital-sign assessments include blood pressure, pulse rate, respiratory rate, temperature, and oxygen saturation measured by pulse oximetry.
Measured: Up to 60 weeks
Secondary outcomes (28)
Annualized Rate of Moderate or Severe COPD Exacerbations During Treatment Period 1
Unadjusted annualized rate of adjudicated moderate or severe exacerbations of COPD. A moderate exacerbation is an acute worsening of COPD requiring systemic corticosteroids and/or antibiotics. A severe exacerbation is an acute worsening of COPD requiring hospital admission for at least 24 hours.
Measured: 52 Weeks
Annualized Rate of Severe COPD Exacerbations During Treatment Period 1
Unadjusted annualized rate of adjudicated severe COPD exacerbations. A severe COPD exacerbation is an acute worsening of COPD requiring hospital admission for at least 24 hours.
Measured: 52 Weeks
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization During Treatment Period 1
Unadjusted annualized rate of COPD exacerbations requiring an emergency department visit and/or hospitalization.
Measured: 52 Weeks
Cumulative Number of Moderate or Severe COPD Exacerbations During Treatment Period 1
Mean cumulative number of adjudicated moderate or severe COPD exacerbation events over time.
Measured: 52 Weeks
Cumulative Number of Severe COPD Exacerbations During Treatment Period 1
Mean cumulative number of adjudicated severe COPD exacerbation events over time.
Measured: 52 Weeks
Time to First Moderate or Severe COPD Exacerbation During Treatment Period 1
Treatment Period 1Time from initiation of C4531015 study intervention to the first adjudicated moderate or severe COPD exacerbation. The probability of an event will be estimated using the Kaplan-Meier method.
Measured: 52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function During Treatment Period 1
Change from the parent-study baseline at each scheduled assessment in the following spirometry parameters: pre-bronchodilator FEV1, post-bronchodilator FEV1, pre-bronchodilator FEV1/FVC ratio, and post-bronchodilator FEV1/FVC ratio. FEV1 is the forced expiratory volume in 1 second, and FVC is the forced vital capacity. Spirometry will be performed using standardized equipment and procedures. Post-bronchodilator measurements will be obtained following administration of a short-acting bronchodilator in accordance with the protocol. FEV1 will be reported in liters, and FEV1/FVC will be reported as a ratio.
Measured: 52 Weeks
Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score During Treatment Period 1
Change from the parent-study baseline in SGRQ total score at each scheduled assessment. The SGRQ contains 50 items assessing symptoms, activity, and impacts on daily life. Total scores range from 0 to 100, with lower scores indicating better quality of life.
Measured: 52 Weeks
Change From Parent-Study Baseline in COPD Assessment Test (CAT) Total Score During Treatment Period 1
Change from the parent-study baseline in CAT total score at each scheduled assessment. The CAT contains 8 items scored from 0 to 5. The total score ranges from 0 to 40, with higher scores indicating worse health.
Measured: 52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication During Treatment Period 1
Change from the parent-study baseline in weekly use of short-acting bronchodilator medication at each protocol-specified assessment. Use of the bronchodilator administered solely for post-bronchodilator spirometry is excluded.
Measured: 52 Weeks
Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score During Treatment Period 1
Percentage of participants classified as SGRQ responders at each scheduled assessment. A responder is a participant with an improvement of at least 4 points from the parent-study baseline in SGRQ total score. An improvement corresponds to a reduction in the total score.
Measured: 52 Weeks
Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score During Treatment Period 1
Percentage of participants classified as CAT responders at each scheduled assessment. A responder is a participant with an improvement of at least 2 points from the parent-study baseline in CAT total score. An improvement corresponds to a reduction in the total score.
Measured: 52 Weeks
COPD Exacerbations in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Unadjusted annualized rate of adjudicated moderate or severe COPD exacerbations in participants with a blood eosinophil count of at least 300 cells/µL at the parent-study baseline
Measured: 52 Weeks
Lung Function in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Change from parent-study baseline in pre-bronchodilator FEV1; change from parent-study baseline in post-bronchodilator FEV1 in participants with a blood eosinophil count of at least 300 cells/µL at the parent-study baseline
Measured: 52 Weeks
Annualized Rate of Moderate or Severe COPD Exacerbations Through End of Study
Unadjusted annualized rate of adjudicated moderate or severe COPD exacerbations over the participant's full period of study participation.
Measured: Up to 36 months
Annualized Rate of Severe COPD Exacerbations Through End of Study
Unadjusted annualized rate of adjudicated severe COPD exacerbations over the participant's full period of study participation.
Measured: Up to 36 months
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization Through End of Study
Unadjusted annualized rate of COPD exacerbations requiring an emergency department visit and/or hospitalization.
Measured: Up to 36 months
Cumulative Number of Moderate or Severe COPD Exacerbations Through End of Study
Mean cumulative number of adjudicated moderate or severe COPD exacerbation events over time.
Measured: Up to 36 months
Cumulative Number of Severe COPD Exacerbations Through End of Study
Mean cumulative number of adjudicated severe COPD exacerbation events over time.
Measured: Up to 36 months
Change From Parent-Study Baseline in COPD Assessment Test total score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Change from parent-study baseline in CAT total score in participants with a blood eosinophil count of at least 300 cells/µL at the parent-study baseline
Measured: 52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function Through End of Study
Change from the corresponding parent-study baseline at each protocol-specified assessment in the following spirometry parameters: pre-bronchodilator FEV1, post-bronchodilator FEV1, pre-bronchodilator FEV1/FVC ratio, and post-bronchodilator FEV1/FVC ratio. FEV1 is forced expiratory volume in 1 second, and FVC is forced vital capacity. Spirometry will be performed using standardized equipment and procedures. Post-bronchodilator measurements will be obtained after administration of a short-acting bronchodilator in accordance with the protocol. FEV1 will be reported in liters and FEV1/FVC as a ratio.
Measured: Up to 36 months
Change From Parent-Study Baseline in SGRQ Total Score After Week 52
Change from the parent-study baseline in SGRQ total score at each scheduled assessment after Week 52 of TP1. Scores range from 0 to 100, with lower scores indicating better quality of life.
Measured: Up to 36 months
Change from the parent-study baseline in CAT total score at each scheduled assessment after Week 52 of TP1
Change from the parent-study baseline in CAT total score at each scheduled assessment after Week 52 of TP1. Scores range from 0 to 40, with higher scores indicating worse health.
Measured: Up to 36 months
Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire total score Total Score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Change from parent-study baseline in Saint George's Respiratory Questionnaire total score in participants with a blood eosinophil count of at least 300 cells/µL at the parent-study baseline
Measured: 52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication After Week 52
Change from the parent-study baseline in weekly use of short-acting bronchodilator medication at each scheduled assessment after Week 52 of TP1.
Measured: Up to 36 months
Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score After Week 52
Percentage of participants with an improvement of at least 4 points from the parent-study baseline in SGRQ total score at each scheduled assessment after Week 52.
Measured: Up to 36 months
Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score After Week 52
Percentage of participants with an improvement of at least 2 points from the parent-study baseline in CAT total score at each scheduled assessment after Week 52.
Measured: Up to 36 months
Time to First Moderate or Severe COPD Exacerbation Through End of Study
Time from initiation of C4531015 study intervention to the first adjudicated moderate or severe COPD exacerbation. The probability of an event will be estimated using the Kaplan-Meier method.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion12 May 2034 (estimated)
- Study completion12 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839884
- Sponsor's protocol ID
- C4531015
- Other IDs
- 2026-528166-19-00
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF TILREKIMIG IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
- ClinicalTrials.gov ID
- NCT07839884
- Acronym / sponsor ID
- C4531015
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 12 May 2034 (estimated)
- Study completion
- 12 May 2034 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Continuation Study of Tilrekimig in Adults with Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About this Medicine when Used for a Long Period of Time.
Detailed description
C4531015 is a multicenter, open-label extension study designed to evaluate the longer-term safety and tolerability of tilrekimig in eligible participants with chronic obstructive pulmonary disease (COPD) who have participated in and completed the applicable requirements of the parent study, C4531031.
Participants who complete the protocol-defined parent-study period may be considered for enrollment in C4531015. Before entering the extension study, participants must provide informed consent, satisfy all C4531015 eligibility criteria, and be considered appropriate for continued study treatment by the investigator. Participation in C4531031 does not automatically establish eligibility for the extension study.
All enrolled participants will receive open-label tilrekimig according to the dose, route of administration, and treatment schedule specified in the C4531015 protocol. Participants may continue protocol-permitted background COPD maintenance therapy. Use of concomitant and rescue medications will be managed according to the protocol.
The study will primarily characterize the safety and tolerability of longer-term exposure to tilrekimig. Safety monitoring will include the collection of adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment interruption or discontinuation, and other protocol-defined safety events. Participants will also undergo clinical laboratory testing, vital-sign assessments, physical examinations, and other safety evaluations at scheduled study visits.
Additional protocol-defined assessments may be conducted to characterize COPD-related clinical outcomes and the effects of continued treatment. These may include evaluation of COPD exacerbations, respiratory symptoms, lung function, health status, participant-reported outcomes (PROs), healthcare resource utilization, pharmacokinetics (PK), immunogenicity, biomarkers, or other exploratory measures, as applicable. These assessments are intended to provide supportive information and should not be interpreted as demonstrating that tilrekimig is safe or effective.
Participants will attend study visits according to the protocol Schedule of Activities (SoA). At these visits, investigators will assess continued eligibility, treatment adherence, changes in health status, AEs, concomitant medications, COPD-related events, and the results of required clinical and laboratory evaluations.
Participants may discontinue study intervention because of an AE, pregnancy, use of prohibited medication, lack of compliance with protocol requirements, an investigator or sponsor decision, withdrawal of consent, or another protocol-defined reason. Participants who discontinue study intervention may be asked to complete applicable early-discontinuation and safety follow-up assessments.
The study may provide eligible participants transitioning from C4531031 with continued access to investigational treatment while allowing additional safety and clinical information to be collected over a longer treatment period. Tilrekimig remains investigational, and participation in the study does not guarantee that an individual participant will experience clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tilrekimig (PF-07275315) | Experimental | Drug: TilrekimigTilrekimig (PF-07275315) subcutaneous injection (sc) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who completed parent study C4531031.
- Individuals of childbearing potential must be willing to use a highly effective method of contraception.
Key exclusion criteria (4 listed)
- Ongoing safety-significant AE.
- Parent-study SAE incompatible with continued participation.
- Medical, laboratory, psychiatric, or behavioral condition that increases risk or interferes with study participation.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TilrekimigAlso: PF-07275315SC injection | Drug | Tilrekimig (PF-07275315) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
Time frame: Up to 60 weeks
Number and percentage of participants with treatment-emergent adverse events. An adverse event is considered treatment-emergent if it begins or increases in severity following initiation of study intervention. Events will be summarized by severity and other protocol-defined characteristics
Number of Participants With Treatment-Emergent Serious Adverse Events During Treatment Period 1
Time frame: Up to 60 weeks
Number and percentage of participants with treatment-emergent serious adverse events. Serious adverse events are events that meet one or more of the protocol-defined seriousness criteria.
Number of Participants With Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Intervention During Treatment Period 1
Time frame: Up to 60 weeks
Number and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.
Number of Participants With Clinically Significant Laboratory Abnormalities During Treatment Period 1
Time frame: Up to 60 weeks
Number and percentage of participants with protocol-defined clinical abnormalities in laboratory values and vitals signs. Laboratory assessments include protocol-required hematology and blood chemistry evaluations. Abnormal laboratory findings will be evaluated according to protocol-defined criteria and investigator assessment of clinical significance. Vital-sign assessments include blood pressure, pulse rate, respiratory rate, temperature, and oxygen saturation measured by pulse oximetry.
28 secondary outcomes
Annualized Rate of Moderate or Severe COPD Exacerbations During Treatment Period 1
Time frame: 52 Weeks
Annualized Rate of Severe COPD Exacerbations During Treatment Period 1
Time frame: 52 Weeks
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization During Treatment Period 1
Time frame: 52 Weeks
Cumulative Number of Moderate or Severe COPD Exacerbations During Treatment Period 1
Time frame: 52 Weeks
Cumulative Number of Severe COPD Exacerbations During Treatment Period 1
Time frame: 52 Weeks
Time to First Moderate or Severe COPD Exacerbation During Treatment Period 1
Time frame: 52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function During Treatment Period 1
Time frame: 52 Weeks
Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score During Treatment Period 1
Time frame: 52 Weeks
Change From Parent-Study Baseline in COPD Assessment Test (CAT) Total Score During Treatment Period 1
Time frame: 52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication During Treatment Period 1
Time frame: 52 Weeks
Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score During Treatment Period 1
Time frame: 52 Weeks
Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score During Treatment Period 1
Time frame: 52 Weeks
COPD Exacerbations in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Time frame: 52 Weeks
Lung Function in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Time frame: 52 Weeks
Annualized Rate of Moderate or Severe COPD Exacerbations Through End of Study
Time frame: Up to 36 months
Annualized Rate of Severe COPD Exacerbations Through End of Study
Time frame: Up to 36 months
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization Through End of Study
Time frame: Up to 36 months
Cumulative Number of Moderate or Severe COPD Exacerbations Through End of Study
Time frame: Up to 36 months
Cumulative Number of Severe COPD Exacerbations Through End of Study
Time frame: Up to 36 months
Change From Parent-Study Baseline in COPD Assessment Test total score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Time frame: 52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function Through End of Study
Time frame: Up to 36 months
Change From Parent-Study Baseline in SGRQ Total Score After Week 52
Time frame: Up to 36 months
Change from the parent-study baseline in CAT total score at each scheduled assessment after Week 52 of TP1
Time frame: Up to 36 months
Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire total score Total Score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Time frame: 52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication After Week 52
Time frame: Up to 36 months
Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score After Week 52
Time frame: Up to 36 months
Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score After Week 52
Time frame: Up to 36 months
Time to First Moderate or Severe COPD Exacerbation Through End of Study
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tilrekimig in people with Moderate to Severe Chronic Obstructive Pulmonary Disease, run by Pfizer.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1) (time frame: Up to 60 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.