A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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
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;
Trial design
Design model
Parallel
Treatments tested in this trial
PF-07275315
Drugsubcutaneous injection
Placebo
Other interventionsubcutaneous injection
Treatment groups
252 Participants
are divided into 4 treatment groupsGroup A: Treatment Arm AExperimental treatment 1 intervention
Group B: Treatment Arm BExperimental treatment 1 intervention
Group C: Treatment Arm CExperimental treatment 1 intervention
Group D: Treatment Arm DPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry.
Time frame
Week 122
Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation
Incidence of treatment-emergent AEs, treatment-emergent SAEs, and treatment-emergent AEs/SAEs leading to treatment discontinuation
Time frame
Baseline through Week 243
Clinically significant, treatment-related laboratory abnormalities
Incidence of clinically significant changes in laboratory tests
Time frame
Baseline through Week 244
Clinically significant, treatment-related abnormalities in vital signs
Incidence of clinically significant changes in vital signs
Time frame
Baseline through Week 24Secondary outcomes
1
Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
Time frame
Week 122
Change from baseline in pre-bronchodilator FEV1 at all time points
Time frame
Baseline through Week 243
Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points
Time frame
Baseline through Week 244
Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points
Time frame
Baseline through Week 24 Source ClinicalTrials.gov