RECRUITING

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

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Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-07
Study Completion:2027-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06676319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
  2. * At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
  3. * Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at Screening (Visit 1).
  1. * Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
  2. * 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).
  3. * Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
  4. * 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.
  5. * 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).
  6. * 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).
  7. * 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.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com

Study Locations (Sites)

The Center for Clinical Trials - Saraland- Site Number : 8400096
Saraland, Alabama, 36571
United States
Chandler Clinical Research Trials- Site Number : 8400075
Chandler, Arizona, 85224
United States
Epic Medical Research - Sun City- Site Number : 8400052
Sun City, Arizona, 85351
United States
Tucson Clinical Research Institute- Site Number : 8400085
Tucson, Arizona, 85712
United States
Modena Allergy + Asthma- Site Number : 8400021
La Jolla, California, 92037
United States
Velocity Clinical Research - San Diego- Site Number : 8400024
La Mesa, California, 91942
United States
Ark Clinical Research- Site Number : 8400097
Long Beach, California, 90815
United States
Downtown L.A. Research Center- Site Number : 8400080
Los Angeles, California, 90017
United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
North Hollywood, California, 91606
United States
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
San Mateo, California, 94403
United States
Modena Allergy And Asthma- Site Number : 8400068
Torrance, California, 90505
United States
Howard University Hospital- Site Number : 8400107
Washington D.C., District of Columbia, 20060
United States
Helix Biomedics- Site Number : 8400005
Boynton Beach, Florida, 33435
United States
Beautiful Minds Clinical Research Center- Site Number : 8400019
Cutler Bay, Florida, 33157
United States
Alfa Medical Research- Site Number : 8400071
Davie, Florida, 33024
United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
DeBary, Florida, 32713
United States
Royal Clinical Trials - Inverness- Site Number : 8400067
Inverness, Florida, 34453
United States
Premier Medical Associates- Site Number : 8400077
Lady Lake, Florida, 32159
United States
D&H Pompano Research Center- Site Number : 8400072
Margate, Florida, 33063
United States
Research Institute of South Florida- Site Number : 8400023
Miami, Florida, 33173
United States
Innovations Biotech- Site Number : 8400044
Miami, Florida, 33186
United States
Oviedo Medical Research - Site number: 8400091
Oviedo, Florida, 32765
United States
Tellabio International Research Services- Site Number : 8400083
Pembroke Pines, Florida, 33025
United States
Avanza Medical Research Center- Site Number : 8400056
Pensacola, Florida, 32503
United States
Hull and Hull Medical Specialists- Site Number : 8400079
Plantation, Florida, 33324
United States
Ilumina Medical Research- Site Number : 8400095
Saint Cloud, Florida, 34769
United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400081
Cordele, Georgia, 31015
United States
EmVenio Research- Site Number : 8400109
Riverdale, Georgia, 30274
United States
Christie Clinic in Champaign on University- Site Number : 8400003
Champaign, Illinois, 61820
United States
Velocity Clinical Research - Rockville- Site Number : 8400036
Rockville, Maryland, 20854
United States
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
Silver Spring, Maryland, 20901
United States
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, 48109
United States
Clarkston Medical Group- Site Number : 8400054
Clarkston, Michigan, 48346
United States
Javara - Mankato Clinic- Site Number : 8400001
Mankato, Minnesota, 56001
United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
Rochester, Minnesota, 55905
United States
Hannibal Regional Healthcare System- Site Number : 8400078
Hannibal, Missouri, 63401
United States
Pioneer Clinical Research - New York- Site Number : 8400092
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai - Mount Sinai Health System- Site Number : 8400069
New York, New York, 10029
United States
Piedmont Healthcare - Family Medicine- Site Number : 8400064
Statesville, North Carolina, 28625
United States
Cleveland Clinic - Cleveland- Site Number : 8400106
Cleveland, Ohio, 44195
United States
Asthma & Allergy Center - Toledo- Site Number : 8400020
Toledo, Ohio, 43617
United States
OK Clinical Research- Site Number : 8400060
Edmond, Oklahoma, 73034
United States
Clinical Research Associates of Central PA- Site Number : 8400013
DuBois, Pennsylvania, 15801
United States
ADAC Research- Site Number : 8400070
Greenville, South Carolina, 29607
United States
Orion Clinical Research
Austin, Texas, 78759
United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400015
Boerne, Texas, 78006
United States
Epic Medical Research - De Soto- Site Number : 8400051
DeSoto, Texas, 75115
United States
Axsendo Clinical Research - Houston- Site Number : 8400065
Houston, Texas, 77058
United States
Radiance Clinical Research
Lampasas, Texas, 76550
United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
McKinney, Texas, 75069
United States
STAAMP Research - San Antonio- Site Number : 8400059
San Antonio, Texas, 78229
United States
Bandera Family Health Care - San Antonio- Site Number : 8400049
San Antonio, Texas, 78249
United States
Javara - San Marcos - Redwood Road- Site Number : 8400040
San Marcos, Texas, 78666
United States
Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400038
Stephenville, Texas, 76401
United States
Simcare Medical Research- Site Number : 8400102
Sugar Land, Texas, 77478
United States
Children's Wisconsin- Site Number : 8400073
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-07
Study Completion Date2027-10-15

Study Record Updates

Study Start Date2024-11-07
Study Completion Date2027-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma