Asthma study: Tilrekimig
Official title A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
ClinicalTrials.gov ID: NCT07772921
What this study is testing
What is tilrekimig?
This is an investigational medicine being studied as a potential treatment for severe asthma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if tilrekimig is safe and works for severe asthma.
- Who it's for
- It is looking for adults who have had severe asthma for at least a year and at least two asthma attacks in the past year.
- What's involved
- Participants will receive either tilrekimig shots or a placebo shot at the clinic and will be monitored for safety and effects.
- Time commitment
- The study lasts several months and requires regular clinic visits for shots and monitoring.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80
You may be able to join if
- History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines.
- Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more
- Positive bronchodilator responsiveness of FEV1 or FVC \>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local...
- Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines...
You likely can't join if
- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the...
- Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40/OX40L, IL-13...
- Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
- Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer).
The study team makes the final eligibility decision.
Where it is enrolling
- Bakersfield, California, United States
- Miami, Florida, United States
- White Marsh, Maryland, United States
- Union City, New Jersey, United States
- Monroe, North Carolina, United States
- Garland, Texas, United States
- Mesquite, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bakersfield, California, United States; Miami, Florida, United States; White Marsh, Maryland, United States; Union City, New Jersey, United States; Monroe, North Carolina, United States; Garland, Texas, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.