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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 9.5 months. During this time, they will have 10 visits at the study clinic.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ 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 12 months of the screening visit.

• Pre-bronchodilator FEV1 of ≥30% to \<80% of predicted normal values during screening period.

• 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 12 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.

Locations
United States
Alabama
Velocity Clinical Research, Mobile
NOT_YET_RECRUITING
Mobile
California
Antelope Valley Clinical Trials
RECRUITING
Lancaster
Allergy and Asthma Associates of Santa Clara Valley Research Center
RECRUITING
San Jose
Allergy & Asthma Clinical Research
RECRUITING
Walnut Creek
New Jersey
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
NOT_YET_RECRUITING
Riverdale
Oklahoma
OK Clinical Research
NOT_YET_RECRUITING
Edmond
Allergy, Asthma and Clinical Research
RECRUITING
Oklahoma City
South Carolina
Clinical Research of Rock Hill
NOT_YET_RECRUITING
Rock Hill
Tennessee
Premier Research Center, LLC
NOT_YET_RECRUITING
Hendersonville
Texas
Alina Clinical Trials, LLC.
NOT_YET_RECRUITING
Dallas
Greater Heights & Memorial Pulmonary and Sleep
RECRUITING
Houston
Other Locations
China
The Third Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
Japan
Fukuwa Clinic
NOT_YET_RECRUITING
Chuo-ku
National Hospital Organization Osaka Minami Medical Center
NOT_YET_RECRUITING
Kawachi-nagano
NHO Kinki Chuo Chest Medical Center
NOT_YET_RECRUITING
Sakai
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2027-08-15
Participants
Target number of participants: 252
Treatments
Experimental: Treatment Arm A
PF-07275315
Experimental: Treatment Arm B
PF-07275315
Experimental: Treatment Arm C
PF-07275315
Placebo_comparator: Treatment Arm D
Placebo
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov