A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma

NCT07772921
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,100
clinicaltrials.gov
Lead sponsor
Pfizer
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Start date
2026-08-24
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Number of sites
2
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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. 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.
clinicaltrials.gov
Short title
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
clinicaltrials.gov
Official title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Not yet recruiting
clinicaltrials.gov
Phase
Phase 3
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Study type
Interventional
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Completion date
2029-09-04
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First posted
2026-08-19
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Registry last updated
2026-08-19
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Primary completion date
2029-06-12
clinicaltrials.gov
Start date
2026-08-24
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Participants
1,100
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Participant count basis
Estimated
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Planned participants
1,100
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Number of sites
2
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07772921
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07772921
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualized asthma exacerbation rate over 52 weeks

    Timeframe: Baseline through Week 52

    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.

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

    Timeframe: 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)

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: 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

    Timeframe: Baseline through Week 52

  6. Annualized asthma exacerbation rate associated with emergency room (ER)/urgent care (UC) visit or hospitalization over 52 weeks

    Timeframe: Baseline through Week 52

  7. Time to first asthma exacerbation

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

  10. Clinical remission at Week 52

    Timeframe: Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

And 11 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
12 Years
Maximum age
80 Years
Healthy volunteers
No

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).

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.

Sources for eligibility
clinicaltrials.gov

  • SMS Clinical Research LLCGarland, United States
  • SMS Clinical Research, LLCMesquite, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-526565-18-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)