PF-07275315
Drugsubcutaneous injection
NCT Number: NCT06977581
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 70 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 12 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 about 7.5 months. During this time, they will have 9 visits at the study clinic.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 2
Fundación Respirar, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Must meet the following asthma criteria:
Other Inclusion Criteria:
Exclusion criteria
Medical Conditions:
Prior/Concomitant Therapy:
Prior/Concurrent Clinical Study Experience:
subcutaneous injection
subcutaneous injection
Time frame: 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: Baseline through Week 24
Incidence of treatment-emergent AEs, treatment-emergent SAEs, and treatment-emergent AEs/SAEs leading to treatment discontinuation
Time frame: Baseline through Week 24
Incidence of clinically significant changes in laboratory tests
Time frame: Baseline through Week 24
Incidence of clinically significant changes in vital signs
Time frame: Baseline through Week 24
Incidence of clinically significant changes in ECG
Time frame: Week 12
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Baseline through Week 24
Time frame: Week 12
Time frame: Week 12
Time frame: Week 12
Time frame: Week 12
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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