Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Purpose
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.
Condition
- Asthma
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lunsekimig |
Participants will receive lunsekimig (SC injection) every 4 weeks |
|
|
Placebo Comparator Placebo |
Participants will receive placebo (SC injection) every 4 weeks |
|
Recruiting Locations
Saraland 4088628, Alabama 4829764 36571
Chandler 5289282, Arizona 5551752 85224
Sun City 5316201, Arizona 5551752 85351
Tucson 5318313, Arizona 5551752 85712
La Jolla 5363943, California 5332921 92037
La Mesa 5363990, California 5332921 91942
Long Beach 5367929, California 5332921 90815
Los Angeles 5368361, California 5332921 90017
North Hollywood 5377654, California 5332921 91606
San Mateo 5392423, California 5332921 94403
Torrance 5403022, California 5332921 90505
Washington D.C. 4140963, District of Columbia 4138106 20060
Boynton Beach 4148677, Florida 4155751 33435
Cutler Bay 6332309, Florida 4155751 33157
DeBary 4152926, Florida 4155751 32713
Hollywood 4158928, Florida 4155751 33024
Inverness 4159786, Florida 4155751 34453
Lady Lake 4161118, Florida 4155751 32159
Margate 4163407, Florida 4155751 33063
Miami 4164138, Florida 4155751 33173
Miami 4164138, Florida 4155751 33186
Oviedo 4167348, Florida 4155751 32765
Pembroke Pines 4168139, Florida 4155751 33025
Pensacola 4168228, Florida 4155751 32503
Plantation 4168782, Florida 4155751 33324
Saint Cloud 4170965, Florida 4155751 34769
Cordele 4189423, Georgia 4197000 31015
Riverdale 4219001, Georgia 4197000 30274
Champaign 4887158, Illinois 4896861 61820
Kansas City 4273837, Kansas 4273857 66160
Rockville 4367175, Maryland 4361885 20854
Silver Spring 4369596, Maryland 4361885 20901
Ann Arbor 4984247, Michigan 5001836 48109
Clarkston 4988997, Michigan 5001836 48346
Mankato 5036420, Minnesota 5037779 56001
Rochester 5043473, Minnesota 5037779 55905
Hannibal 4389418, Missouri 4398678 63401
New York 5128581, New York 5128638 10011
New York 5128581, New York 5128638 10016
Statesville 4493316, North Carolina 4482348 28625
Cleveland 5150529, Ohio 5165418 44195
Toledo 5174035, Ohio 5165418 43617
Edmond 4535740, Oklahoma 4544379 73034
DuBois 5187432, Pennsylvania 6254927 15801
Philadelphia 4560349, Pennsylvania 6254927 19107
Greenville 4580543, South Carolina 4597040 29607
Austin 4671654, Texas 4736286 78759
Boerne 4675373, Texas 4736286 78006
DeSoto 4685524, Texas 4736286 75115
Houston 4699066, Texas 4736286 77058
Lampasas 4705176, Texas 4736286 76550
McKinney 4710178, Texas 4736286 75069
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78249
San Marcos 4726491, Texas 4736286 78666
Stephenville 4734350, Texas 4736286 76401
Sugar Land 4734825, Texas 4736286 77478
Milwaukee 5263045, Wisconsin 5279468 53226
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com