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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

18 settembre 2026 aggiornato da: Pfizer

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1360

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 35 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

INCLUSION CRITERIA

  • Participants who completed parent study C4531031.
  • Individuals of childbearing potential must be willing to use a highly effective method of contraception.

EXCLUSION CRITERIA

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tilrekimig (PF-07275315)

Tilrekimig (PF-07275315) subcutaneous injection (sc)
Droga: Tilrekimig

SC injection

Altri nomi:
  • PF-07275315

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
Lasso di tempo: 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
Up to 60 weeks
Number of Participants With Treatment-Emergent Serious Adverse Events During Treatment Period 1
Lasso di tempo: 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.
Up to 60 weeks
Number of Participants With Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Intervention During Treatment Period 1
Lasso di tempo: Up to 60 weeks

Number and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.
Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During Treatment Period 1
Lasso di tempo: 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.
Up to 60 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annualized Rate of Moderate or Severe COPD Exacerbations During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Annualized Rate of Severe COPD Exacerbations During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization During Treatment Period 1
Lasso di tempo: 52 Weeks

Unadjusted annualized rate of COPD exacerbations requiring an emergency department visit and/or hospitalization.
52 Weeks
Cumulative Number of Moderate or Severe COPD Exacerbations During Treatment Period 1
Lasso di tempo: 52 Weeks

Mean cumulative number of adjudicated moderate or severe COPD exacerbation events over time.
52 Weeks
Cumulative Number of Severe COPD Exacerbations During Treatment Period 1
Lasso di tempo: 52 Weeks

Mean cumulative number of adjudicated severe COPD exacerbation events over time.
52 Weeks
Time to First Moderate or Severe COPD Exacerbation During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Change From Parent-Study Baseline in COPD Assessment Test (CAT) Total Score During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score During Treatment Period 1
Lasso di tempo: 52 Weeks

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.
52 Weeks
COPD Exacerbations in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Lasso di tempo: 52 Weeks

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
52 Weeks
Lung Function in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL
Lasso di tempo: 52 Weeks

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
52 Weeks
Annualized Rate of Moderate or Severe COPD Exacerbations Through End of Study
Lasso di tempo: Up to 36 months

Unadjusted annualized rate of adjudicated moderate or severe COPD exacerbations over the participant's full period of study participation.
Up to 36 months
Annualized Rate of Severe COPD Exacerbations Through End of Study
Lasso di tempo: Up to 36 months

Unadjusted annualized rate of adjudicated severe COPD exacerbations over the participant's full period of study participation.
Up to 36 months
Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization Through End of Study
Lasso di tempo: Up to 36 months

Unadjusted annualized rate of COPD exacerbations requiring an emergency department visit and/or hospitalization.
Up to 36 months
Cumulative Number of Moderate or Severe COPD Exacerbations Through End of Study
Lasso di tempo: Up to 36 months

Mean cumulative number of adjudicated moderate or severe COPD exacerbation events over time.
Up to 36 months
Cumulative Number of Severe COPD Exacerbations Through End of Study
Lasso di tempo: Up to 36 months

Mean cumulative number of adjudicated severe COPD exacerbation events over time.
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
Lasso di tempo: 52 Weeks

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
52 Weeks
Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function Through End of Study
Lasso di tempo: Up to 36 months

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.
Up to 36 months
Change From Parent-Study Baseline in SGRQ Total Score After Week 52
Lasso di tempo: Up to 36 months

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.
Up to 36 months
Change from the parent-study baseline in CAT total score at each scheduled assessment after Week 52 of TP1
Lasso di tempo: Up to 36 months

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.
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
Lasso di tempo: 52 Weeks

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
52 Weeks
Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication After Week 52
Lasso di tempo: Up to 36 months

Change from the parent-study baseline in weekly use of short-acting bronchodilator medication at each scheduled assessment after Week 52 of TP1.
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
Lasso di tempo: Up to 36 months

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.
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
Lasso di tempo: Up to 36 months

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.
Up to 36 months
Time to First Moderate or Severe COPD Exacerbation Through End of Study
Lasso di tempo: Up to 36 months

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.
Up to 36 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

21 settembre 2026

Completamento primario (Stimato)

12 maggio 2034

Completamento dello studio (Stimato)

12 maggio 2034

Date di iscrizione allo studio

Primo inviato

18 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 settembre 2026

Primo Inserito (Effettivo)

24 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C4531015
  • 2026-528166-19-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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