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

NCT06676319
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
556
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Lead sponsor
Sanofi
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Start date
2024-11-07
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Number of sites
230
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Summary
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.
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Acronym
AIRLYMPUS
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Short title
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
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Official title
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
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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
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-07-19
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First posted
2024-11-06
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Registry last updated
2026-07-01
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Primary completion date
2027-06-21
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Start date
2024-11-07
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Actual participants
556
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Participants
556
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
230
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Data monitoring committee
Yes
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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
NCT06676319
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ClinicalTrials.gov ID
NCT06676319
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualized rate of asthma exacerbation events

    Timeframe: From baseline up to 52 weeks

    Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma

  1. Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    Timeframe: From baseline to week 52

  2. Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score

    Timeframe: From baseline to week 52

    The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.

  3. Change from baseline in FeNO level

    Timeframe: From baseline to week 52

  4. Annualized rate of loss of asthma control events (LOAC) events

    Timeframe: From baseline to week 52

    Annualized rate of LOAC events defined by 1 or more of the following criteria: * ≥30% reduction from baseline in morning PEF on 2 consecutive days * ≥6 additional reliever puffs of SABA in a 24-hour period (compared to baseline) on 2 consecutive days OR ≥4 additional puffs of low-dose budesonide/formoterol or budesonide/albuterol in a 24-hour period (compared to baseline) on 2 consecutive days * Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days * Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids (asthma exacerbation event) * Death due to asthma

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

    Timeframe: From baseline to week 52

  6. Total systemic corticosteroid dose exposure

    Timeframe: From baseline to week 52

  7. Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores

    Timeframe: From baseline to week 52

  8. Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score

    Timeframe: From baseline to week 52

  9. Serum lunsekimig concentrations

    Timeframe: From baseline to week 56

  10. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

    Timeframe: From baseline to week 56

  11. 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 56

Sources for outcomes
clinicaltrials.gov

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

  • 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).

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.

Sources for eligibility
clinicaltrials.gov

  • The Center for Clinical Trials - Saraland- Site Number : 8400096Saraland, United States
  • Chandler Clinical Research Trials- Site Number : 8400075Chandler, United States
  • Epic Medical Research - Sun City- Site Number : 8400052Sun City, United States
  • Tucson Clinical Research Institute- Site Number : 8400085Tucson, United States
  • Ark Clinical Research- Site Number : 8400097Long Beach, United States
  • Downtown L.A. Research Center- Site Number : 8400080Los Angeles, United States
  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400061North Hollywood, United States
  • Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062San Mateo, United States
  • Stanford University Medical Center- Site Number : 8400108Stanford, United States
  • Modena Allergy And Asthma- Site Number : 8400068Torrance, United States
  • Howard University Hospital- Site Number : 8400107Washington D.C., United States
  • Helix Biomedics- Site Number : 8400005Boynton Beach, United States
  • Beautiful Minds Clinical Research Center- Site Number : 8400019Cutler Bay, United States
  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082DeBary, United States
  • Alfa Medical Research- Site Number : 8400071Hollywood, United States
  • Royal Clinical Trials - Inverness- Site Number : 8400067Inverness, United States
  • Premier Medical Associates- Site Number : 8400077Lady Lake, United States
  • D&H Pompano Research Center- Site Number : 8400072Margate, United States
  • Research Institute of South Florida- Site Number : 8400023Miami, United States
  • Innovations Biotech- Site Number : 8400044Miami, United States
  • Tellabio International Research Services- Site Number : 8400083Pembroke Pines, United States
  • Avanza Medical Research Center- Site Number : 8400056Pensacola, United States
  • Hull and Hull Medical Specialists- Site Number : 8400079Plantation, United States
  • Ilumina Medical Research- Site Number : 8400095Saint Cloud, United States
  • Cordele, United States

And 205 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-513959-33
  • U1111-1301-3938
Sources for references
clinicaltrials.gov

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