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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT06102005

Run by

Sanofi

People needed

685

Starts

2023-10-16

Expected to finish

2026-03-11

Last updated by the study team

2026-03-17

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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