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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT06676319

Run by

Sanofi

People needed

556

Starts

2024-11-07

Expected to finish

2027-07-19

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 it is running

• Chandler Clinical Research Trials- Site Number : 8400075 — Chandler, Arizona, United States
• Epic Medical Research - Sun City- Site Number : 8400052 — Sun City, Arizona, United States
• Tucson Clinical Research Institute- Site Number : 8400085 — Tucson, Arizona, United States
• Ark Clinical Research- Site Number : 8400097 — Long Beach, California, United States
• Downtown L.A. Research Center- Site Number : 8400080 — Los Angeles, California, United States
• Carbon Health - North Hollywood - NoHo West- Site Number : 8400061 — North Hollywood, California, United States
• Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062 — San Mateo, California, United States
• Stanford University Medical Center- Site Number : 8400108 — Stanford, California, United States
• Modena Allergy And Asthma- Site Number : 8400068 — Torrance, California, United States
• Howard University Hospital- Site Number : 8400107 — Washington D.C., District of Columbia, United States
• Helix Biomedics- Site Number : 8400005 — Boynton Beach, Florida, United States
• Beautiful Minds Clinical Research Center- Site Number : 8400019 — Cutler Bay, Florida, United States
• Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082 — DeBary, Florida, United States
• Alfa Medical Research- Site Number : 8400071 — Hollywood, Florida, United States
• Royal Clinical Trials - Inverness- Site Number : 8400067 — Inverness, Florida, United States
• Premier Medical Associates- Site Number : 8400077 — Lady Lake, Florida, United States
• D&H Pompano Research Center- Site Number : 8400072 — Margate, Florida, United States
• Research Institute of South Florida- Site Number : 8400023 — Miami, Florida, United States
• Innovations Biotech- Site Number : 8400044 — Miami, Florida, United States
• Tellabio International Research Services- Site Number : 8400083 — Pembroke Pines, Florida, United States
• Avanza Medical Research Center- Site Number : 8400056 — Pensacola, Florida, United States
• Hull and Hull Medical Specialists- Site Number : 8400079 — Plantation, Florida, United States
• Ilumina Medical Research- Site Number : 8400095 — Saint Cloud, Florida, United States
• Private Practice - Dr. David Kavtaradze- Site Number : 8400081 — Cordele, Georgia, United States
• The Center for Clinical Trials - Saraland- Site Number : 8400096 — Saraland, Alabama, United States

Full record on ClinicalTrials.gov

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