At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Lunsekimig (drug), Short-Acting Beta Agonists (SABA) (drug), Placebo (drug), Fluticasone/Salmeterol (drug)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- Lunsekimig — drug: Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection · Short-Acting Beta Agonists (SABA) — drug: Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation · Placebo — drug: Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection · Fluticasone/Salmeterol — drug: Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation · Budesonide/Formoterol — drug: Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation · Budesonide/Albuterol — drug: Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 556
- Started
- 2024-11-07
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for asthma
- • Phase2 - 556 participants
- • This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with asthma
Where?
- • Ruislip - Investigational Site Number : 8260009
- • Corby - Investigational Site Number : 8260007
- • Nottingham - Investigational Site Number : 8260006
- • Oxford - Investigational Site Number : 8260008
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include: * The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
- ✓At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
- ✓Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at...
Who cannot take part
- ✗Participants are excluded from the study if any of the following criteria apply:
- ✗Other severe lung diseases (eg, chronic obstructive lung disease \[COPD\]. bronchiectasis, idiopathic lung...
- ✗Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to...
- ✗NOTE: The above information is not intended to contain all considerations relevant to a patient's potential...
See the full criteria
Where Is This Study? (7 UK sites)
Investigational Site Number : 8260009
Ruislip HA4 8NX, United Kingdom
Investigational Site Number : 8260007
Corby NN17 2UN, United Kingdom
Investigational Site Number : 8260006
Nottingham NG7 2UH, United Kingdom
Investigational Site Number : 8260008
Oxford OX3 9DU, United Kingdom
Investigational Site Number : 8260005
Barnsley S75 2EP, United Kingdom
Investigational Site Number : 8260003
Bradford BD9 6DA, United Kingdom
Investigational Site Number : 8260001
London W1G 8HU, United Kingdom
