A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and effects of PF-07275315 in adults ages 18 to 75 with moderate-to-severe asthma that is not well controlled. Participants get the study medicine or a placebo, which has no medicine, as shots at a clinic over 12 weeks. Taking part may last up to about 9.5 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 75 years old.
- You have had ongoing moderate-to-severe asthma for at least 12 months.
- You had at least one asthma flare-up in the past 24 months that needed steroid pills or injections for at least 3 days.
- Before airway-opening medicine, at least 2 of 3 breathing test results, and their average, must be at least 30% but below 80% of the expected normal value.
- A breathing test must improve by at least 12% and 200 mL after airway-opening medicine.
- For at least 6 months, you have used a medium- or high-dose inhaled steroid with a long-acting airway-opening medicine. Your dose has been steady for at least 3 months.
- Your asthma symptom score, called ACQ-5, is at least 1.5 at screening and before you are assigned a treatment.
- Your body mass index, a measure based on height and weight, is between 18 and 40.
Who can't join
- You have a health or mental health condition, or an abnormal lab result, that could make the study unsafe or unsuitable. This includes current suicidal thoughts or actions, or any in the past year.
- You have evidence of a lung disease other than asthma.
- You have a parasite infection needing treatment within 2 weeks before screening; an infection needing a hospital stay or injected infection medicine within 60 days before Day 1; or an infection the study doctor considers serious or linked to weak immune defenses within 6 months before Day 1.
- You use a medicine the study does not allow, or cannot or will not use a required medicine. Past or current use of certain targeted immune treatments for asthma or related immune conditions also rules you out.
- You used steroid pills or injections, including joint injections, within 28 days before screening. You received immune-protein supplements within 12 weeks before screening or plan to receive them during the study.
- You have had anaphylaxis, a severe allergic reaction, to an antibody medicine, PF-07275315, or an ingredient in the study products.
- You had bronchial thermoplasty, a procedure that uses heat to treat asthma, within the past 24 months.
- You received an experimental drug within 30 days before screening, or longer if it takes more time to leave your body. You cannot join another experimental drug or vaccine study while taking part.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Must meet the following asthma criteria: 1. History of persistent, moderate-to-severe asthma for at least 12 months prior to screening. 2. 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. 3. 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. 4. Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period. 5. 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. 6. ACQ-5 score of ≥1.5 at screening visit and prior to randomization. Other Inclusion Criteria: 7. Body mass index between 18 -40 kg/m2 at screening. Exclusion Criteria: Medical Conditions: 1. 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. 2. 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 3. 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: 4. Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 5. 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. 6. Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit. 7. Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig). 8. History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products. 9. Bronchial thermoplasty within the previous 24 months. Prior/Concurrent Clinical Study Experience: 10. 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.
Study sites (36)
AL
- Velocity Clinical Research, Mobile · Mobile, AL 36608More trials in Mobile
AZ
- Chandler Clinical Trials · Chandler, AZ 85224More trials in Chandler
CA
- Antelope Valley Clinical Trials · Lancaster, CA 93534More trials in Lancaster
- NewportNativeMD, Inc. · Newport Beach, CA 92663More trials in Newport Beach
- California Medical Research Associates · Northridge, CA 91324More trials in Northridge
- Allergy and Asthma Associates of Santa Clara Valley Research Center · San Jose, CA 95117More trials in San Jose
- Allergy & Asthma Clinical Research · Walnut Creek, CA 94598More trials in Walnut Creek
CO
- Colorado ENT & Allergy · Colorado Springs, CO 80923More trials in Colorado Springs
GA
- Cpcc-Research Llc · East Point, GA 30344More trials in East Point
IL
- Christie Clinic - University · Champaign, IL 61820More trials in Champaign
- Innovo Research - Christie Clinic · Champaign, IL 61820More trials in Champaign
- Christie Clinic - Windsor · Champaign, IL 61822More trials in Champaign
KS
- University of Kansas Medical Center · Kansas City, KS 66160More trials in Kansas City
MI
- North Ingalls Building · Ann Arbor, MI 48109More trials in Ann Arbor
- University of Michigan · Ann Arbor, MI 48109More trials in Ann Arbor
MO
- Washington University School of Medicine · St Louis, MO 63110More trials in St Louis
NC
- American Health Research · Charlotte, NC 28277More trials in Charlotte
- Clinical Research Of Gastonia · Gastonia, NC 28054More trials in Gastonia
- Stern Research Partners, LLC · Huntersville, NC 28078More trials in Huntersville
NJ
- Rutgers, Robert Wood Johnson Medical School · New Brunswick, NJ 08901More trials in New Brunswick
- Circuit Clinical / Impact Medical Allergy, Asthma & Immunology · Riverdale, NJ 07457More trials in Riverdale
NV
- Henderson Clinical Trials · Henderson, NV 89052More trials in Henderson
OH
- Toledo Institute of Clinical Research Inc. · Toledo, OH 43617More trials in Toledo
OK
- OK Clinical Research · Edmond, OK 73034More trials in Edmond
- Allergy, Asthma and Clinical Research · Oklahoma City, OK 73120More trials in Oklahoma City
- Layrek Clinical Research · Tulsa, OK 74133More trials in Tulsa
PA
- Clinical Research Associates of Central PA, LLC · DuBois, PA 15801More trials in DuBois
SC
- Clinical Research of Rock Hill · Rock Hill, SC 29732More trials in Rock Hill
TN
- Premier Research Center, LLC · Hendersonville, TN 37075More trials in Hendersonville
TX
- South Texas Medical Research Institute, Inc., DBA TTS Research · Boerne, TX 78006More trials in Boerne
- Horizon Clinical Research Group · Cypress, TX 77429More trials in Cypress
- Alina Clinical Trials, LLC. · Dallas, TX 75209More trials in Dallas
- Greater Heights & Memorial Pulmonary and Sleep · Houston, TX 77008More trials in Houston
- Houston Pulmonary Sleep and Allergy Associates · Houston, TX 77065More trials in Houston
- Metroplex Pulmonary and Sleep Center · McKinney, TX 75069More trials in McKinney
VA
- Clinical Research Partners, LLC · Richmond, VA 23226More trials in Richmond