Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

NCT06102005
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Phase
Phase 2
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Recruitment status
Completed
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Participants
685
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Lead sponsor
Sanofi
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Start date
2023-10-16
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Number of sites
156
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Summary
This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.
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Acronym
AIRCULES
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Short title
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
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Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-03-11
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First posted
2023-10-26
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Registry last updated
2026-03-17
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Primary completion date
2026-02-23
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Start date
2023-10-16
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Actual participants
685
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Participants
685
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
156
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06102005
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ClinicalTrials.gov ID
NCT06102005
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Annualized rate of asthma exacerbation events

    Timeframe: From baseline to week 48

  1. Change from baseline in pre-bronchodilator (BD) FEV1

    Timeframe: From baseline to week 48

  2. Change from baseline in post-BD FEV1

    Timeframe: From baseline to week 48

  3. The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)

    Timeframe: From baseline to week 48

  4. Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score

    Timeframe: From baseline to week 48

    ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control

  5. Change from baseline in ACQ-5 score

    Timeframe: From baseline to week 48

  6. Change from baseline in FeNO

    Timeframe: From baseline to week 48

  7. Time to first asthma exacerbation

    Timeframe: From baseline to week 48

  8. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit

    Timeframe: From baseline to week 48

  9. Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief

    Timeframe: From baseline to week 48

  10. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores

    Timeframe: From baseline to week 48

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

  11. Proportion of participants with ≥4-point improvement in SGRQ score

    Timeframe: From baseline to week 48

  12. Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores

    Timeframe: From baseline to week 48

  13. Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores

    Timeframe: From baseline to week 48

  14. Change from baseline in ACQ scores

    Timeframe: From baseline to week 48

  15. Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score

    Timeframe: From baseline to week 48

  16. Serum lunsekimig concentrations

    Timeframe: From baseline to week 52

  17. Anti-drug antibodies (ADA) against lunsekimig

    Timeframe: From baseline to week 52

  18. Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

    Timeframe: From baseline to week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
  • 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
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
  • 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 or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
  • 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
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Sources for eligibility
clinicaltrials.gov

  • Allergy, Asthma & Immunology Associates- Site Number : 8400009Scottsdale, United States
  • Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072Yuma, United States
  • Antelope Valley Clinical Trials- Site Number : 8400020Lancaster, United States
  • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032Northridge, United States
  • Optimus Medical- Site Number : 8400046San Francisco, United States
  • Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038San Jose, United States
  • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053Thousand Oaks, United States
  • Allianz Research Institute CO- Site Number : 8400026Aurora, United States
  • Velocity Clinical Research - Denver- Site Number : 8400027Englewood, United States
  • Western States Clinical Research- Site Number : 8400014Wheat Ridge, United States
  • Beautiful Minds Clinical Research Center- Site Number : 8400049Cutler Bay, United States
  • Qway Research - Hialeah- Site Number : 8400015Hialeah, United States
  • Clintex Research Group - Miami - Coral Way- Site Number : 8400048Miami, United States
  • High Quality Research- Site Number : 8400039Miami, United States
  • Innovations Biotech- Site Number : 8400040Miami, United States
  • New Access Medical Center- Site Number : 8400043Miami, United States
  • Deluxe Health Center- Site Number : 8400045Miami Lakes, United States
  • Advanced Research Institute - New Port Richey- Site Number : 8400044New Port Richey, United States
  • Pines Care Research Center- Site Number : 8400057Pembroke Pines, United States
  • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019Sarasota, United States
  • Appalachian Clinical Research- Site Number : 8400050Calhoun, United States
  • PMG Research of Christie Clinic- Site Number : 8400066Champaign, United States
  • Velocity Clinical Research Lafayette Site Number : 8400060Lafayette, United States
  • Javara - Privia Medical Group - Annapolis- Site Number : 8400033Annapolis, United States
  • Brigham & Women's Hospital- Site Number : 8400034Boston, United States

And 131 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1280-5514
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)