Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,100 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for people with severe asthma who have had multiple asthma attacks in the past year. Participants will receive either the study medicine tilrekimig or a placebo to see if it helps improve their condition.
Are You a Good Fit for This Trial?
Rules you outChronic obstructive pulmonary diseaseCystic fibrosisPulmonary fibrosisPulmonary embolism
You may be able to join if
I have been diagnosed with severe asthma for at least 12 months.
I have had at least 2 asthma attacks in the last year.
I use a medium-to-high dose of an inhaled steroid plus another asthma medication.
I have responded positively to a bronchodilator test.
You may not be able to join if
I have other lung diseases besides asthma.
I have a psychiatric condition that affects my ability to participate.
I have used systemic corticosteroids in the last 28 days.
I have received certain asthma treatments or therapies in the last 12 weeks.
I have had bronchial thermoplasty in the last 24 months.
I participated in another clinical study in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
* Hav…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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.
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