Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06676319
The ClinicalTrials.gov registry entry for NCT06676319 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 1,147 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (26% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
-
Escitalopram in Asthma Patients With Frequent Exacerbation
RECRUITING · Phase 2
-
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
RECRUITING · Phase 2
-
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
RECRUITING · Phase 2
-
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
RECRUITING · Phase 2
-
Supplementing L-citrulline to Overweight Late Asthma oNset Phenotypes
RECRUITING · Phase 2
-
Study to Improve Deployment Related Asthma by Using L-Citrulline Supplementation
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.