Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Public ClinicalTrials.gov record NCT06676319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06676319
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 556 participants
Conditions and interventions
Conditions
Interventions
- Lunsekimig Drug
- Short-Acting Beta Agonists (SABA) Drug
- Placebo Drug
- Fluticasone/Salmeterol Drug
- Budesonide/Formoterol Drug
- Budesonide/Albuterol Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 6, 2024
- Primary completion
- Jun 20, 2027
- Completion
- Jul 18, 2027
- Last update posted
- Jun 30, 2026
2024 – 2027
United States locations
- U.S. sites
- 54
- U.S. states
- 20
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Center for Clinical Trials - Saraland- Site Number : 8400096 | Saraland | Alabama | 36571 | — |
| Chandler Clinical Research Trials- Site Number : 8400075 | Chandler | Arizona | 85224 | — |
| Epic Medical Research - Sun City- Site Number : 8400052 | Sun City | Arizona | 85351 | — |
| Tucson Clinical Research Institute- Site Number : 8400085 | Tucson | Arizona | 85712 | — |
| Ark Clinical Research- Site Number : 8400097 | Long Beach | California | 90815 | — |
| Downtown L.A. Research Center- Site Number : 8400080 | Los Angeles | California | 90017 | — |
| Carbon Health - North Hollywood - NoHo West- Site Number : 8400061 | North Hollywood | California | 91606 | — |
| Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062 | San Mateo | California | 94403 | — |
| Stanford University Medical Center- Site Number : 8400108 | Stanford | California | 94305 | — |
| Modena Allergy And Asthma- Site Number : 8400068 | Torrance | California | 90505 | — |
| Howard University Hospital- Site Number : 8400107 | Washington D.C. | District of Columbia | 20060 | — |
| Helix Biomedics- Site Number : 8400005 | Boynton Beach | Florida | 33435 | — |
| Beautiful Minds Clinical Research Center- Site Number : 8400019 | Cutler Bay | Florida | 33157 | — |
| Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082 | DeBary | Florida | 32713 | — |
| Alfa Medical Research- Site Number : 8400071 | Hollywood | Florida | 33024 | — |
| Royal Clinical Trials - Inverness- Site Number : 8400067 | Inverness | Florida | 34453 | — |
| Premier Medical Associates- Site Number : 8400077 | Lady Lake | Florida | 32159 | — |
| D&H Pompano Research Center- Site Number : 8400072 | Margate | Florida | 33063 | — |
| Research Institute of South Florida- Site Number : 8400023 | Miami | Florida | 33173 | — |
| Innovations Biotech- Site Number : 8400044 | Miami | Florida | 33186 | — |
| Tellabio International Research Services- Site Number : 8400083 | Pembroke Pines | Florida | 33025 | — |
| Avanza Medical Research Center- Site Number : 8400056 | Pensacola | Florida | 32503 | — |
| Hull and Hull Medical Specialists- Site Number : 8400079 | Plantation | Florida | 33324 | — |
| Ilumina Medical Research- Site Number : 8400095 | Saint Cloud | Florida | 34769 | — |
| Private Practice - Dr. David Kavtaradze- Site Number : 8400081 | Cordele | Georgia | 31015 | — |
| EmVenio Research - Riverdale- Site Number : 8400109 | Riverdale | Georgia | 30274 | — |
| Christie Clinic in Champaign on University- Site Number : 8400003 | Champaign | Illinois | 61820 | — |
| University of Kansas Medical Center- Site Number : 8400105 | Kansas City | Kansas | 66160 | — |
| Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036 | Rockville | Maryland | 20854 | — |
| Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042 | Silver Spring | Maryland | 20901 | — |
| University of Michigan Health System - Ann Arbor- Site Number : 8400014 | Ann Arbor | Michigan | 48109 | — |
| Clarkston Medical Group- Site Number : 8400054 | Clarkston | Michigan | 48346 | — |
| Javara - Mankato Clinic- Site Number : 8400001 | Mankato | Minnesota | 56001 | — |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400057 | Rochester | Minnesota | 55905 | — |
| Hannibal Regional Healthcare System- Site Number : 8400078 | Hannibal | Missouri | 63401 | — |
| Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069 | New York | New York | 10011 | — |
| Pioneer Clinical Research - New York- Site Number : 8400092 | New York | New York | 10016 | — |
| Piedmont Healthcare - Family Medicine- Site Number : 8400064 | Statesville | North Carolina | 28625 | — |
| Cleveland Clinic - Cleveland- Site Number : 8400106 | Cleveland | Ohio | 44195 | — |
| Asthma & Allergy Center - Toledo- Site Number : 8400020 | Toledo | Ohio | 43617 | — |
| OK Clinical Research- Site Number : 8400060 | Edmond | Oklahoma | 73034 | — |
| Clinical Research Associates of Central Pennsylvania- Site Number : 8400013 | DuBois | Pennsylvania | 15801 | — |
| Thomas Jefferson University Hospital- Site Number : 8400110 | Philadelphia | Pennsylvania | 19107 | — |
| Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070 | Greenville | South Carolina | 29607 | — |
| Orion Clinical Research | Austin | Texas | 78759 | — |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400015 | Boerne | Texas | 78006 | — |
| Epic Medical Research - De Soto- Site Number : 8400051 | DeSoto | Texas | 75115 | — |
| Axsendo Clinical Research - Houston- Site Number : 8400065 | Houston | Texas | 77058 | — |
| Metroplex Pulmonary and Sleep Center- Site Number : 8400012 | McKinney | Texas | 75069 | — |
| STAAMP Research - San Antonio- Site Number : 8400059 | San Antonio | Texas | 78229 | — |
| Bandera Family Health Care - San Antonio- Site Number : 8400049 | San Antonio | Texas | 78249 | — |
| Javara - San Marcos - Redwood Road- Site Number : 8400040 | San Marcos | Texas | 78666 | — |
| Simcare Medical Research- Site Number : 8400102 | Sugar Land | Texas | 77478 | — |
| Children's Wisconsin- Site Number : 8400073 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06676319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06676319 live on ClinicalTrials.gov.