A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

A vizsgálat adatai

Ki végzi

Pfizer

Azonosító

NCT06977581EU 2024-517866-40-00

A regiszteradat frissítve

2026. november 6.

Eredeti leírás

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected.A teljes eredeti leírásKevesebb

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ASTHMA

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected.

This study is seeking participants who:

* Are 18 to 75 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 6 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 12 weeks. We will compare the experiences 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 will be involved in this study for up to approximately 9.5 months depending on local requirements.

Bevonási feltételek: Must meet the following asthma criteria:; History of persistent, moderate-to-severe asthma for at least 12 months prior to screening; Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 24 months of the screening visit; At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to <80% of predicted normal values; Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period; Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit; ACQ-5 score of ≥1.5 at screening visit and prior to randomization; Other Inclusion Criteria:; Body mass index between 18 -40 kg/m2 at screening.

Kizáró feltételek: Diagnosed with any of the following acute or chronic infections or infection history:; Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening; Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1; Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1; Prior/Concomitant Therapy:; Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s); Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4, IL-13, IL-33/ST2, IL-4Rα, TSLP, IL-5, OX40/OX40L 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: AD, EoE, CRS; Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit; Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig); Bronchial thermoplasty within the previous 24 months; Prior/Concurrent Clinical Study Experience:; Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study; Medical Conditions:; Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis; History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products; Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

ClinicalTrials.gov NCT06977581 · EU CTIS 2024-517866-40-00