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
Pfizer
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.
Eligibility
- Age range
- 12–80 years
- Sex
- All
- 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 i…
Interventions
- Drugtilrekimig
subcutaneous injection
- OtherPlacebo
subcutaneous injection
Locations (2)
- SMS Clinical Research LLCGarland, Texas
- SMS Clinical Research, LLCMesquite, Texas