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RecruitingNCT07869043Updated Oct 9, 2026

A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma

A Phase 3 interventional study of tilrekimig and Placebo in Asthma, sponsored by Pfizer. Recruiting at 3 sites in United States. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
12 Years to 80 Years
Sex
All
01

Study summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.

The study is seeking participants who:

  • Have a history of severe asthma for at least 12 months
  • Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. Tilrekimig or the placebo will be given about every 4 weeks during the study.

The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.

02

Conditions studied

  • Asthma

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03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,100 participants (estimated)

Study arms

  • Experimental
    Treatment Arm A Tilrekimig

    Tilrekimig

    Drug: tilrekimig

  • Placebo comparator
    Treatment Arm B Placebo

    Placebo

    Other: Placebo

Interventions

  • Drugtilrekimig

    subcutaneous injection

  • OtherPlacebo

    subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Annualized asthma exacerbation rate over 52 weeks

    Protocol defined asthma exacerbations require 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.

    Time frame: Baseline through Week 52

Secondary outcomes

  1. Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts ≥300 cells/µL (ie, high eosinophil subgroup)

    Time frame: Baseline through Week 52

  2. Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts <300 cells/µL (ie, medium-to-low eosinophil subgroup)

    Time frame: Baseline through Week 52

  3. Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52

    Time frame: Baseline through Week 52

  4. CFB in Asthma Control Questionnaire (ACQ-5) at Week 52

    Time frame: Baseline through Week 52

  5. CFB in Asthma Quality of Life Questionnaire for 12 years and older Self-Administered (AQLQ(S)-12-SA) at Week 52

    Time frame: Baseline through Week 52

  6. Annualized asthma exacerbation rate requiring Emergency Room or Urgent Care (ER/UC) visit or hospitalization over 52 weeks

    Time frame: Baseline through Week 52

  7. Time to first asthma exacerbation

    Time frame: Baseline through Week 52

  8. CFB in weekly mean Asthma Nighttime Symptom Diary (ANSD) at Week 52

    Time frame: Baseline through Week 52

  9. CFB in weekly mean Asthma Daytime Symptom Diary (ADSD) at Week 52

    Time frame: Baseline through Week 52

  10. Clinical remission at Week 52

    Time frame: Week 52

  11. CFB in pre-bronchodilator FEV1 at all time points (other than Week 52)

    Time frame: Baseline through Week 52

  12. CFB in ACQ-5 all time points (other than Week 52)

    Time frame: Baseline through Week 52

  13. CFB in AQLQ(S)-12-SA at all time points (other than Week 52)

    Time frame: Baseline through Week 52

  14. CFB in weekly mean ANSD at all time points (other than Week 52)

    Time frame: Baseline through Week 52

  15. CFB in weekly mean ADSD at all time points (other than Week 52)

    Time frame: Baseline through Week 52

  16. CFB in pre-bronchodilator % Predicted FEV1 at all time points

    Time frame: Baseline through Week 52

  17. CFB in pre-bronchodilator forced vital capacity (FVC) at all time points

    Time frame: Baseline through Week 52

  18. CFB in pre-bronchodilator % Predicted FVC at all time points

    Time frame: Baseline through Week 52

  19. CFB in pre-bronchodilator FEV1/FVC ratio at all time points

    Time frame: Baseline through Week 52

  20. CFB in post-bronchodilator FEV1 at all time points

    Time frame: Baseline through Week 52

  21. CFB in post-bronchodilator % Predicted FEV1 at all time points

    Time frame: Baseline through Week 52

  22. CFB in post-bronchodilator FVC at all time points

    Time frame: Baseline through Week 52

  23. CFB in post-bronchodilator % Predicted FVC at all time points

    Time frame: Baseline through Week 52

  24. CFB in post-bronchodilator FEV1/FVC ratio at all time points

    Time frame: Baseline through Week 52

  25. ACQ-5 response: decrease from baseline in ACQ-5 ≥0.5 at all time points

    Time frame: Baseline through Week 52

  26. AQLQ response: increase from baseline in AQLQ(S)-12-SA ≥0.5 at all time points

    Time frame: Baseline through Week 52

  27. Time to first asthma exacerbation requiring ER/UC visit or hospitalization

    Time frame: Baseline through Week 52

  28. Clinical remission at Week 24

    Time frame: Week 24

  29. Event of ≥1 asthma exacerbation over 52 weeks

    Time frame: Baseline through Week 52

  30. Event of ≥1 asthma exacerbation associated with ER/UC visit or hospitalization over 52 weeks

    Time frame: Baseline through Week 52

  31. CFB in Patient global impression of disease severity (PGI-S) at all time points

    Time frame: Baseline through Week 52

  32. Patient global impression of change in clinical status (PGI-C) at all time points

    Time frame: Baseline through Week 52

  33. Annualized asthma exacerbation rate over 52 weeks by baseline fractional exhaled nitric oxide (FeNO) subgroup (<25 parts per billion (ppb), ≥25 to <50 ppb, ≥50 ppb)

    Time frame: Baseline through Week 52

  34. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: Baseline through Week 64

  35. Incidence of treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuation

    Time frame: Baseline through Week 64

  36. Incidence of clinical abnormalities in clinical laboratory values, vital signs or electrocardiograms

    Time frame: Baseline through Week 64

07

Study locations

2 of 3 sites recruiting
  • Allergy and Clinical Immunology Associates
    Pittsburgh, Pennsylvania 15241, United States
    Recruiting
  • Orion Clinical Research
    Austin, Texas 78759, United States
    Recruiting
  • DM Clinical Research
    Tomball, Texas 77375, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869043
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Sep 30, 2026
Primary completion
Jun 7, 2029 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Oct 9, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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