RecruitingPhase 3

A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of tilrekimig and how well it may treat severe asthma. It is for people who have had severe asthma for at least 12 months and at least 2 asthma attacks in the past 12 months. Participants get shots of tilrekimig or a placebo (a shot with no study medicine) at the study clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have ongoing, severe asthma for at least 12 months before screening.
  • Have had at least 2 asthma attacks in the past 12 months that needed steroid pills or shots for at least 3 days, an emergency or urgent care visit with that steroid treatment, or a hospital stay of at least 24 hours.
  • Have a breathing test during screening that improves after using albuterol or a similar quick-relief inhaler. The improvement must be more than 10% of your predicted breathing test value.
  • Have used a medium-to-high dose inhaled steroid plus another asthma control medicine for at least 12 months, with no dose change in the 3 months before screening.

Who can't join

  • Have signs of a lung disease other than asthma, based on a medical exam, breathing tests, or lung images within the past 12 months.
  • Have a mental health condition that could make the study unsafe or unsuitable. This includes active thoughts of suicide in the past year or suicidal behavior in the past 5 years.
  • Use medicines the study does not allow, or cannot or will not use required medicines. This includes steroid pills or injections within 28 days before screening.
  • Have had or currently use biologic medicines or targeted synthetic drugs for asthma or other type 2 inflammatory diseases. These are treatments aimed at specific parts of the immune system.
  • Have received extra antibodies, called immunoglobulin treatment, within 12 weeks before the first screening visit, or plan to receive them during the study.
  • Have had bronchial thermoplasty, a procedure that uses heat to treat asthma, within the past 24 months.
  • Have received an experimental drug within 30 days before screening, or longer if the drug takes more time to leave the body.
  • Have been in another tilrekimig study, or take part in another experimental drug or vaccine study during this study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (7)

CA

FL

MD

NC

NJ

TX