Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.

NCT06609239 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.

Conditions Studied

Interventions

  • DRUG Lunsekimig

Study Locations (20)

Florida

  • Helix Biomedics- Site Number : 8400114 — Boynton Beach
  • Beautiful Minds Clinical Research Center- Site Number : 8400049 — Cutler Bay
  • Qway Research - Hialeah- Site Number : 8400015 — Hialeah
  • Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048 — Miami
  • High Quality Research- Site Number : 8400039 — Miami
  • Innovations Biotech- Site Number : 8400040 — Miami
  • New Access Medical Center- Site Number : 8400043 — Miami
  • Deluxe Health Center- Site Number : 8400045 — Miami Lakes
  • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019 — Sarasota

Texas

  • Orion Clinical Research- Site Number : 8400001 — Austin
  • South Texas Medical Research Institute - TTS Research- Site Number : 8400010 — Boerne
  • Baylor University Medical Center- Site Number : 8400002 — Dallas

Colorado

  • Allianz Research Institute - Aurora- Site Number : 8400026 — Aurora
  • Western States Clinical Research- Site Number : 8400014 — Wheat Ridge

Michigan

  • University of Michigan Health System - Ann Arbor- Site Number : 8400004 — Ann Arbor

Missouri

  • Midwest Clinical Research Center - St. Louis- Site Number : 8400006 — St Louis

North Carolina

  • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029 — Charlotte

Ohio

  • Asthma & Allergy Center - Toledo- Site Number : 8400017 — Toledo

Oklahoma

  • OK Clinical Research- Site Number : 8400021 — Edmond

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2024-09-30
Est. Completion 2031-01-20
Phase Phase 2

Sponsor

Sanofi

275 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06609239

The ClinicalTrials.gov registry entry for NCT06609239 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention — of which Lunsekimig is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06609239 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06609239 about?

NCT06609239 is a clinical study titled "Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.". This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in ...

What is the current status of trial NCT06609239?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 900 participants. The study started on 2024-09-30. Estimated completion is 2031-01-20.

What conditions does trial NCT06609239 study?

This clinical trial studies the following conditions: Asthma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06609239?

The interventions under investigation include: Lunsekimig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06609239?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06609239 being conducted?

This trial has 20 study locations across Colorado, Florida, Michigan, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial