Asthma
Conditions
Brief 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.
Interventions
DRUGtilrekimig
subcutaneous injection
OTHERPlacebo
subcutaneous injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized asthma exacerbation rate over 52 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts ≥300 cells/µL (ie, high eosinophil subgroup) | Baseline through Week 52 |
| 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) | Baseline through Week 52 |
| Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52 | Baseline through Week 52 |
| CFB in Asthma Control Questionnaire (ACQ-5) at Week 52 | Baseline through Week 52 |
| CFB in Asthma Quality of Life Questionnaire for 12 years and older Self-Administered (AQLQ(S)-12-SA) at Week 52 | Baseline through Week 52 |
| Annualized asthma exacerbation rate associated with emergency room (ER)/urgent care (UC) visit or hospitalization over 52 weeks | Baseline through Week 52 |
| Time to first asthma exacerbation | Baseline through Week 52 |
| CFB in weekly mean Asthma Nighttime Symptom Diary (ANSD) at Week 52 | Baseline through Week 52 |
| CFB in weekly mean Asthma Daytime Symptom Diary (ADSD) at Week 52 | Baseline through Week 52 |
| Clinical remission at Week 52 | Week 52 |
| CFB in pre-bronchodilator FEV1 at all time points (other than Week 52) | Baseline through Week 52 |
| CFB in ACQ-5 all time points (other than Week 52) | Baseline through Week 52 |
| CFB in AQLQ(S)-12-SA at all time points (other than Week 52 | Baseline through Week 52 |
| CFB in weekly mean ANSD at all time points (other than Week 52) | Baseline through Week 52 |
| CFB in weekly mean ADSD at all time points (other than Week 52) | Baseline through Week 52 |
| CFB in pre-bronchodilator % Predicted FEV1 at all time points | Baseline through Week 52 |
| CFB in pre-bronchodilator forced vital capacity (FVC) at all time points | Baseline through Week 52 |
| CFB in pre-bronchodilator % Predicted FVC at all time points | Baseline through Week 52 |
| CFB in pre-bronchodilator FEV1/FVC ratio at all time points | Baseline through Week 52 |
| CFB in post-bronchodilator FEV1 at all time points | Baseline through Week 52 |
| CFB in post-bronchodilator % Predicted FEV1 at all time points | Baseline through Week 52 |
| CFB in post-bronchodilator FVC at all time points | Baseline through Week 52 |
| CFB in post-bronchodilator % Predicted FVC at all time points | Baseline through Week 52 |
| CFB in post-bronchodilator FEV1/FVC ratio at all time points | Baseline through Week 52 |
| ACQ-5 response: decrease from baseline in ACQ-5 ≥ 0.5 at all time points | Baseline through Week 52 |
| AQLQ response: increase from baseline in AQLQ(S)-12-SA≥ 0.5 at all time points | Baseline through Week 52 |
| Time to first asthma exacerbation associated with ER/UC visit or hospitalization | Baseline through Week 52 |
| Clinical remission at Week 24 | Baseline through Week 24 |
| Event of ≥1 asthma exacerbation over 52 weeks | Baseline through Week 52 |
| Event of ≥1 asthma exacerbation associated with ER/UC visit or hospitalization over 52 weeks | Baseline through Week 52 |
| CFB in Patient Global Impression of Severity (PGI-S) at all time points | Baseline through Week 52 |
| Patient Global Impression of Change (PGI-C) at all time points | Baseline through Week 52 |
| Annualized asthma exacerbation rate over 52 weeks by baseline FeNO subgroup (<25 ppb, ≥25 to <50 ppb, ≥50 ppb) | Baseline through Week 52 |
| Incidence and severity of treatment-emergent adverse events (TEAEs). | Baseline through Week 64 |
| Incidence of treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuation. | Baseline through Week 64 |
| Incidence of clinical abnormalities in clinical laboratory values, vital signs or electrocardiograms | Baseline through Week 64 |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed