Tilrekimig for 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 randomized, controlled Phase 3 trial compares tilrekimig to placebo in adults with persistent severe asthma. Participants receive injections at the study clinic and are monitored for safety and asthma outcomes. The study aims to determine whether tilrekimig is safe and effective in reducing asthma exacerbations and improving lung function. Eligibility requires a history of severe asthma for at least 12 months and multiple asthma-related events in the prior year. The trial is conducted at multiple sites under Pfizer sponsorship to generate data for potential approval and labeling decisions.

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

• Kern Research, Inc.
  Bakersfield, California, United States Recruiting
• Innovations Biotech
  Miami, Florida, United States Recruiting
• Chesapeake Clinical Research, Inc.
  White Marsh, Maryland, United States Recruiting
• Hudson County Clinical Trials Research Center, LLC
  Union City, New Jersey, United States Recruiting
• Monroe Biomedical Research
  Monroe, North Carolina, United States Recruiting
• SMS Clinical Research LLC
  Garland, Texas, United States Recruiting

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.