Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

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 is a Phase 3 interventional trial to evaluate the safety and potential effectiveness of tilrekimig in adults with severe asthma. Participants are randomly assigned to receive either tilrekimig or placebo, with injections every four weeks at the study clinics. Eligibility focuses on a history of long-standing, severe asthma and recent exacerbations requiring systemic steroids or related urgent care. Outcomes will compare safety and respiratory outcomes between the tilrekimig and placebo groups. The study is sponsored by Pfizer and conducted at several sites in Illinois, Missouri, and New York.

Why it matters

Who can join: the full rules

Inclusion Criteria

Must meet the following asthma criteria:

1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines.
2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\<24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma with within 12 months of the screening visit.
3. Positive bronchodilator responsiveness of FEV1 or FVC \>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol/albuterol (or equivalent SABA) at least once for spirometry conducted during screening period.

   Other Inclusion Criteria:
4. Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

1. 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, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.
2. Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.

   Prior/Concomitant Therapy:
3. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.
4. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40/OX40L, IL-13, IL-33 / ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.
5. Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
6. Bronchial thermoplasty within the previous 24 months.

   Prior/Concurrent Clinical Study Experience:
7. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.

Where it's running

• Asthma and Allergy Center of Chicago
  River Forest, Illinois, United States Recruiting
• Allergy and Clinical Immunology Associates
  Pittsburgh, Pennsylvania, United States Recruiting
• Orion Clinical Research
  Austin, Texas, United States Recruiting
• DM Clinical Research
  Tomball, Texas, United States Recruiting
• Hannibal Regional Healthcare System, Inc.
  Hannibal, Missouri, United States Not yet recruiting
• Urban Health Plan
  The Bronx, New York, United States Not yet recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

• Biologics for Type 2 Inflammation in Asthma and COPD in Real World

  This real-world study tests whether six biologic drugs can reduce flare-ups and improve symptoms in adults with asthma or COPD treated in routine care in China.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07823842

• GSK5784283 vs placebo in uncontrolled asthma (PERSIST ASTHMA-2)

  A new medicine called GSK5784283 is being tested to see if it lowers asthma flare-ups better than a placebo in people with uncontrolled asthma.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · San Diego, California and 6 other locations · NCT07782996

• GSK5784283 vs placebo for uncontrolled asthma

  This study tests whether GSK5784283 reduces asthma flare-ups more than a placebo in people with uncontrolled asthma.

  Recruiting Phase 3 GlaxoSmithKline · Miami Lakes, Florida · NCT07780643

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.