Clinical trial • Phase II • Respiratory
PF-07275315 for Moderate-to-severe asthma
Phase II trial of PF-07275315 for Moderate-to-severe asthma.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Moderate-to-severe asthma
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 19-05-2025
- First CTIS Authorization Date
- 26-08-2025
Trial design
Randomised, placebo (comparator arm: placebo; no dose/schedule specified in provided record)-controlled Phase II trial across 35 sites in Belgium, Bulgaria, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo (comparator arm: placebo; no dose/schedule specified in provided record)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 162
Eligibility
Recruits 162 Vulnerable population not selected (isVulnerablePopulationSelected: false). Participants are adults (18-70 years). Separate informed consent documents include pregnant partner ICFs (documents titled L2_Pregnant Partner_ICF) and multiple language ICFs; no specific assent/consent procedures for children or other vulnerable groups are described in the provided record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected: false). Participants are adults (18-70 years). Separate informed consent documents include pregnant partner ICFs (documents titled L2_Pregnant Partner_ICF) and multiple language ICFs; no specific assent/consent procedures for children or other vulnerable groups are described in the provided record.
Inclusion criteria
- {"criterion_text":"- 18 to 70 years of age (or the minimum age of consent in accordance with local regulations) at screening.\n- History of persistent, moderate-to-severe asthma for at least 12 months prior to screening and have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit.\n- Must have a history of bronchodilator responsiveness or positive methacholine challenge test confirming an asthma diagnosis.\n- Pre-bronchodilator FEV1 of ≥30% to <80% of the predicted normal values during screening period.\n- Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL, at 15 - 30 minutes (or consistent with local treatment practices after inhaling 400 μg of salbutamol / albuterol (or equivalent Short-Acting Beta-Agonists [SABA]) at least once for spirometry conducted during screening period.\n- Maintenance (controller) treatment that minimally includes a medium to high dose inhaled corticosteroids - long-acting beta 2 agonists (ICS -LABA) combination consistent with Global Initiative for Asthma (GINA) Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.\n- Body mass index between 18-40 kg/m2 at screening\n- ACQ-5 score of ≥1.5 at screening visit and prior to randomization (on at least 1 of the Week -2, Week -1 or Day 1 [pre-dose] visits)."}
Exclusion criteria
- {"criterion_text":"- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) within 12 months of the screening visit, as per local standard of care.\n- Chronic obstructive pulmonary disease or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis) which may impair lung function tests.\n- Diagnosed with any acute or chronic infections or infection history.\n- Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n- Treatment with any dose level of systemic (oral or injectable) corticosteroids within 28 days of the screening visit through the end of study (except to treat an acute exacerbation).\n- Prior or concurrent treatment with either approved or experimental biologics (such as inhibitors of IL-4Rα, TSLP, IL-5 or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases including but not limited to: atopic dermatitis (AD), eosinophilic esophagitis (EoE), chronic rhinosinusitis (CRS).\n- Cigarette smoking history of ≥10 pack-years.\n- Active smoking or vaping within 12 months of the screening visit."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline (CFB) in pre-bronchodilator forced expiratory volume (in mL) in one second (FEV1) at Week 12.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured in mL at Week 12 (pre-bronchodilator spirometry)."}
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs, all causality and treatment-related).","definition_or_measurement_approach":"Incidence (frequency) of TEAEs recorded during treatment; includes all causality and treatment-related events as captured in safety reporting."}
- {"endpoint_text":"- Incidence of treatment-emergent serious adverse events (SAEs).","definition_or_measurement_approach":"Incidence (frequency) of SAEs occurring during the treatment period as per standard SAE definitions."}
- {"endpoint_text":"- Discontinuations due to TEAEs or SAEs.","definition_or_measurement_approach":"Number/proportion of participants who discontinue study drug due to TEAEs or SAEs during the study."}
- {"endpoint_text":"- Clinically significant, treatment-related abnormal laboratory values, vital signs or electrocardiograms.","definition_or_measurement_approach":"Assessment of clinically significant laboratory, vital signs or ECG abnormalities judged by investigator/sponsor as treatment-related."}
Secondary endpoints
- {"endpoint_text":"- Key Secondary: • CFB in pre-bronchodilator % predicted FEV1, at Week 12.","definition_or_measurement_approach":"Change from baseline in percent predicted pre-bronchodilator FEV1 at Week 12."}
- {"endpoint_text":"- Other Secondary: CFB in pre-bronchodilator lung function parameters (ie, FEV1 *, % predicted FEV1*, Forced vital capacity [FVC], % predicted FVC, FEV1/FVC ratio) at all other time points.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator lung function parameters (FEV1, % predicted FEV1, FVC, % predicted FVC, FEV1/FVC) measured at study time points."}
- {"endpoint_text":"- CFB in post-bronchodilator lung function parameters (ie, FEV1 , % predicted FEV1, FVC , % predicted FVC, FEV1/FVC ratio) at all other time points.","definition_or_measurement_approach":"Change from baseline in post-bronchodilator lung function parameters (FEV1, % predicted FEV1, FVC, % predicted FVC, FEV1/FVC) measured at study time points."}
- {"endpoint_text":"- CFB in FEV1 as a % of pre-BD result.","definition_or_measurement_approach":"Change from baseline in FEV1 expressed as a percentage of the pre-bronchodilator result."}
- {"endpoint_text":"- CFB in pre-bronchodilator FEV1 at Week 12.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured at Week 12."}
- {"endpoint_text":"- CFB in pre-bronchodilator FEV1 at Week 12.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured at Week 12."}
- {"endpoint_text":"- CFB in asthma control questionnaire (5-question version [ACQ-5]) total score at Week 12.","definition_or_measurement_approach":"Change from baseline in ACQ-5 total score assessed at Week 12."}
- {"endpoint_text":"- CFB in asthma quality of life questionnaire with standardized activities (AQLQ) self-administered global score at Week 12.","definition_or_measurement_approach":"Change from baseline in AQLQ self-administered global score at Week 12."}
- {"endpoint_text":"- CFB in pre- bronchodilator FEV1 at Week 12.","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 measured at Week 12."}
Recruitment
- Registry Or Advocacy Recruitment
- True, advocacy group alerts referenced (documents titled 'Advocacy Group Alert' / 'Advocacy Group Study Alert' are present; specific advocacy organisation names are not provided in the record).
- Digital Remote Recruitment
- True, recruitment materials include website content, paid search keywords, digital media boards, Facebook mockups, and eConsent/ePRO capabilities (IQVIA listed as responsible for eConsent and ePRO).
- Planned Sample Size
- 162
- Recruitment Window Months
- 20
- Consent Approach
- Informed consent provided by adult participants (study population 18 to 70 years). Multiple language informed consent forms and information documents are provided (English, French, Dutch, Bulgarian, Spanish, Polish, Italian, Czech, Hungarian - multiple country-specific ICF documents are listed). eConsent capability is indicated (IQVIA duties include eConsent and ePRO). Separate ICFs for pregnant partners and optional retained research/sample consent documents are present.
Methods
- Website postings (country-specific website materials present e.g., K4/K10 recruitment website documents).
- Digital paid search keywords and digital advertising (documents: Paid Search Keywords, Digital Media Board).
- Social media mockups (Facebook Page MockUp documents).
- Study brochures and study posters (country-specific study brochures and posters).
- Outbound call / call scripts and referral emails (Outbound_call_script, Referal_email documents).
- Prescreener questionnaires (Prescreener documents).
- Advocacy group alerts (documents titled Advocacy Group Alert / Advocacy Group Study Alert).
- Use of vendor/site recruitment support (third parties with recruitment duties listed, e.g., Continuum Clinical LLC).
Geography
- Total Number Of Sites
- 35
- Total Number Of Participants
- 90
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pneumology
- Contact Person Name
- Guy Brusselle
- Contact Person Email
- guy.brusselle@uzgent.be
- Site Name
- A.Z. Sint-Maarten
- Department Name
- Pneumology
- Contact Person Name
- Muriel Lins
- Contact Person Email
- muriel.lins@emmaus.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pneumology
- Contact Person Name
- Maud Deschampheleire
- Contact Person Email
- maud.deschampheleire@citadelle.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 47
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Medical Center Pulmovision Ltd.
- Contact Person Name
- Miroslav Mihailov
- Contact Person Email
- miroslavmihailov@abv.bg
- Site Name
- Medical Center Pulmo-2018 EOOD
- Contact Person Name
- Veselin Kalfov
- Contact Person Email
- kalfov@abv.bg
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Contact Person Name
- Maria Staevska-Kotasheva
- Contact Person Email
- mari66sta@gmail.com
- Site Name
- Medical Center New Rehabilitation Center EOOD
- Contact Person Name
- Dimo Dimov
- Contact Person Email
- dmdimov65@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 15-07-2025
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 45
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Pneumology
- Contact Person Name
- Jose Maria Echave-Sustaeta
- Contact Person Email
- jose.echave@quironsalud.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Pneumology
- Contact Person Name
- Jose Luis Velasco Garrido
- Contact Person Email
- jlvelascogarrido@hotmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pneumology
- Contact Person Name
- David Romero Ribate
- Contact Person Email
- davizrom@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Allergy
- Contact Person Name
- Ismael Garcia-Moguel
- Contact Person Email
- ismaelgmoguel@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Contact Person Name
- Juan Garcia Rivero
- Contact Person Email
- Juanluis.garcia@scsalud.es
Poland
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 25
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Malopolskie Centrum Alergologii Sp. z o.o.
- Contact Person Name
- Małgorzata Bederska
- Contact Person Email
- malgorzatabederska@gmail.com
- Site Name
- Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
- Contact Person Name
- Danuta Madra-Rogacka
- Contact Person Email
- dmadrarogacka@gmail.com
- Site Name
- DOBROSTAN Gabinety Lekarskie
- Contact Person Name
- Ewa Pisarczyk-Bogacka
- Contact Person Email
- bogacka@alergia.gigabox.pl
- Site Name
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
- Contact Person Name
- Bernadetta Majorek-Olechowska
- Contact Person Email
- bernadettaolechowska@gmail.com
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- Contact Person Name
- Ewa Springer
- Contact Person Email
- e.springer@wp.pl
- Site Name
- KLIMED Marek Klimkiewicz
- Department Name
- Poradnia Pulmonologiczna
- Contact Person Name
- Justyna Kołodyńska-Jeridi
- Contact Person Email
- kolodynska.klimed@onet.pl
- Site Name
- PULMAG Grzegorz Gasior Marzena Kociolek S.C.
- Contact Person Name
- Grzegorz Gasior
- Contact Person Email
- grzegorz.g15@wp.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- MUDr. I. Cierna Peterova s.r.o.
- Contact Person Name
- Ivana Čierná Peterová
- Contact Person Email
- trnbrnl@gmail.com
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Ústav klinické imunologie a alergiologie
- Contact Person Name
- Irena Krčmová
- Contact Person Email
- irena.krcmova@fnhk.cz
- Site Name
- MediTrial s.r.o.
- Contact Person Name
- Petr Kopecký
- Contact Person Email
- kopir@post.cz
- Site Name
- Cefispiro s.r.o.
- Contact Person Name
- Petra Filipová
- Contact Person Email
- pphilip@seznam.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 28-08-2025
- Processing Time Days
- 55
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Omnimodus Elixir Kft.
- Contact Person Name
- Erika Unger
- Contact Person Email
- ungerstudy@gmail.com
- Site Name
- Szalay János Rendelőintézet
- Department Name
- Tüdőgondozó
- Contact Person Name
- Edina Kurucz
- Contact Person Email
- drkuruczedina@gmail.com
- Site Name
- Erzsebet Gondozohaz Kft.
- Contact Person Name
- Janos Mucsi
- Contact Person Email
- mucsitrial@gmail.com
- Site Name
- Da Vinci Spa Kft.
- Contact Person Name
- Marta Papp
- Contact Person Email
- drpappm@gmail.com
- Site Name
- Edelenyi Koch Robert Korhaz Es Rendelointezet
- Contact Person Name
- Melinda Szabo
- Contact Person Email
- pulmo.szbt@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 12-08-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 171
- Number Of Sites
- 7
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- UOC Clinica Pneumologica
- Contact Person Name
- Alessandro Vatrella
- Contact Person Email
- avatrella@unisa.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Arcispedale Santa Maria Nuova - Dipartimento di Medicine Specialistiche - SC Pneumologia
- Contact Person Name
- Chiara Scelfo
- Contact Person Email
- chiara.scelfo@ausl.re.it
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- U.O.C. Malattie dell'apparato respiratorio
- Contact Person Name
- Paolo Cameli
- Contact Person Email
- paolo.cameli@unisi.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SSDU ASMA GRAVE, MALATTIE RARE DEL POLMONE E FISIOPATOLOGIA RESPIRATORIA
- Contact Person Name
- Fabio Luigi Massimo Ricciardolo
- Contact Person Email
- fabioluigimassimo.ricciardolo@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- UO allergologia e immunologia clinica - Policlinico Universitario Monserrato
- Contact Person Name
- Stefano Del Giacco
- Contact Person Email
- delgiacco@unica.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- SCDU Allergologia e Immunologia Clinica
- Contact Person Name
- Luisa Brussino
- Contact Person Email
- lbrussino@mauriziano.it
- Site Name
- IRCCS Humanitas Research Hospital
- Department Name
- Personalized medicine asthma and allergy unit
- Contact Person Name
- Enrico Marco Heffler
- Contact Person Email
- enrico.heffler@hunimed.eu
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Clinical research services (duty code 4 per record)
- Name
- IQVIA Limited
- Responsibilities
- eConsent and ePRO (and other data services)
- Name
- PAREXEL International GmbH
- Responsibilities
- Ancillary supplies and safety reporting
- Name
- Continuum Clinical LLC
- Responsibilities
- Recruitment
- Name
- eResearchTechnology GmbH
- Responsibilities
- Spirometry/electronic data capture for spirometry
- Name
- Innovative Trials Limited
- Responsibilities
- Operational support (duty codes 2 and 7 as listed)
Third parties
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant Stipend; (additional duty code: 5)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Code 4 (role listed, no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry; Code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Codes 1 and 15; eConsent and ePRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Codes 2 and 7 (roles listed, no textual duties provided)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"Anxillary Supplies, Safety reporting","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PF-07275315
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Investigational (MIA/IMP11510/00002)
- Investigational Product Name
- Placebo
- Modality
- Other
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