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NCT06676319 · ClinicalTrials.gov registry record · Phase 2
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
A Phase 2 study of Asthma, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 1,147
- Enrollment target
- 20
- Study locations
NCT06676319: Recruiting Phase 2 study of Asthma, sponsored by Sanofi.
NCT06676319 is a Phase 2 study of Asthma that is actively recruiting participants, run by Sanofi. The registered enrollment target is 1,147 participants, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06676319, a Phase 2 study of Asthma, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,147 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lunsekimig
- DRUG Short-Acting Beta Agonists (SABA)
- DRUG Fluticasone/Salmeterol
- DRUG Budesonide/Formoterol
Study Locations (20)
Florida
- Helix Biomedics- Site Number : 8400005 - Boynton Beach
- Beautiful Minds Clinical Research Center- Site Number : 8400019 - Cutler Bay
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082 - DeBary
- Alfa Medical Research- Site Number : 8400071 - Hollywood
- Royal Clinical Trials - Inverness- Site Number : 8400067 - Inverness
- Premier Medical Associates- Site Number : 8400077 - Lady Lake
- D&H Pompano Research Center- Site Number : 8400072 - Margate
- Research Institute of South Florida- Site Number : 8400023 - Miami
California
- Modena Allergy + Asthma- Site Number : 8400021 - La Jolla
- Velocity Clinical Research - San Diego- Site Number : 8400024 - La Mesa
- Ark Clinical Research- Site Number : 8400097 - Long Beach
- Downtown L.A. Research Center- Site Number : 8400080 - Los Angeles
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400061 - North Hollywood
- Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062 - San Mateo
- Modena Allergy And Asthma- Site Number : 8400068 - Torrance
Arizona
- Chandler Clinical Research Trials- Site Number : 8400075 - Chandler
- Epic Medical Research - Sun City- Site Number : 8400052 - Sun City
- Tucson Clinical Research Institute- Site Number : 8400085 - Tucson
Alabama
- The Center for Clinical Trials - Saraland- Site Number : 8400096 - Saraland
District of Columbia
- Howard University Hospital- Site Number : 8400107 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2027-10-15 |
| Phase | Phase 2 |
What NCT06676319 shows while recruiting
NCT06676319 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06676319 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06676319 about?
NCT06676319 is a clinical study titled "Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma". 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 partic...
What is the current status of trial NCT06676319?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,147 participants. The study started on 2024-11-07. Estimated completion is 2027-10-15.
What conditions does trial NCT06676319 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT06676319?
The interventions under investigation include: Placebo (DRUG), Lunsekimig (DRUG), Short-Acting Beta Agonists (SABA) (DRUG), Fluticasone/Salmeterol (DRUG), Budesonide/Formoterol (DRUG).
Who is sponsoring clinical trial NCT06676319?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06676319 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06676319's enrollment target sits among peer trials
1,147 33rd of 374 higher than 342 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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