Can a new shot tame severe asthma attacks?
NCT ID NCT07772921
Registered, but not yet taking participants.
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing whether an investigational drug called tilrekimig can reduce the number of severe asthma attacks in adults and adolescents with a history of frequent exacerbations. Participants will receive either tilrekimig or a placebo as a subcutaneous injection, and researchers will compare the annualized rate of asthma attacks over 52 weeks. The study aims to see if tilrekimig is safe and effective for people whose asthma is not well controlled despite standard care.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- tilrekimig (an investigational drug given as a subcutaneous injection)
- What this could lead to
- If successful, tilrekimig could offer a new treatment option to reduce severe asthma attacks and improve quality of life for people with difficult-to-control asthma.
- What could go wrong
- This is an early-stage test in a large group; the drug may not prove more effective than placebo, and side effects are possible. Results will take time and may not apply to all asthma patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SMS Clinical Research LLC
Garland, Texas, 75043, United States
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SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
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