Investigating PF-07275315 for treating moderate-to-severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a medication called PF-07275315 in individuals suffering from moderate-to-severe asthma. Participants aged 18 to 70 with poorly controlled asthma will receive either the study medication or a placebo through multiple injections over a 12-week period. The study will compare the outcomes of those receiving PF-07275315 to those receiving the placebo to determine its effectiveness in improving asthma control. The trial focuses on individuals who have experienced asthma exacerbations and have been on maintenance treatments for at least a year.

Why it matters

Who can join: the full rules

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.

Where it's running

• Velocity Clinical Research, Mobile
  Mobile, Alabama, United States Recruiting
• Chandler Clinical Trials
  Chandler, Arizona, United States Recruiting
• Antelope Valley Clinical Trials
  Lancaster, California, United States Recruiting
• NewportNativeMD, Inc.
  Newport Beach, California, United States Recruiting
• California Medical Research Associates
  Northridge, California, United States Recruiting
• Allergy and Asthma Associates of Santa Clara Valley Research Center
  San Jose, California, United States Recruiting

+87 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.