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ACTIVE NOT RECRUITINGPhase2

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

Sponsor: Sanofi

NCT ID: NCT06676319

View on ClinicalTrials.gov ↗

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.

Asthma

How this trial compares with your answers

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What we know so far

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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
Inclusion Criteria: * 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 Screening (Visit 1). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function. * Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation). * Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1). * Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment). * Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1). * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease. NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

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

Data sourced from ClinicalTrials.gov · Last verified: 2026-09