๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-30

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (NCT06676319)

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sanofi

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: The Center for Clinical Trials - Saraland- Site Number : 8400096 โ€” Saraland, Alabama

Age range: 18 Years to 80 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

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Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (230 Sites)

Showing the first 25 of 230 sites.

  • The Center for Clinical Trials - Saraland- Site Number : 8400096 โ€” Saraland, Alabama
  • Chandler Clinical Research Trials- Site Number : 8400075 โ€” Chandler, Arizona
  • Epic Medical Research - Sun City- Site Number : 8400052 โ€” Sun City, Arizona
  • Tucson Clinical Research Institute- Site Number : 8400085 โ€” Tucson, Arizona
  • Ark Clinical Research- Site Number : 8400097 โ€” Long Beach, California
  • Downtown L.A. Research Center- Site Number : 8400080 โ€” Los Angeles, California
  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400061 โ€” North Hollywood, California
  • Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062 โ€” San Mateo, California
  • Stanford University Medical Center- Site Number : 8400108 โ€” Stanford, California
  • Modena Allergy And Asthma- Site Number : 8400068 โ€” Torrance, California
  • Howard University Hospital- Site Number : 8400107 โ€” Washington D.C., District of Columbia
  • Helix Biomedics- Site Number : 8400005 โ€” Boynton Beach, Florida
  • Beautiful Minds Clinical Research Center- Site Number : 8400019 โ€” Cutler Bay, Florida
  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082 โ€” DeBary, Florida
  • Alfa Medical Research- Site Number : 8400071 โ€” Hollywood, Florida
  • Royal Clinical Trials - Inverness- Site Number : 8400067 โ€” Inverness, Florida
  • Premier Medical Associates- Site Number : 8400077 โ€” Lady Lake, Florida
  • D&H Pompano Research Center- Site Number : 8400072 โ€” Margate, Florida
  • Research Institute of South Florida- Site Number : 8400023 โ€” Miami, Florida
  • Innovations Biotech- Site Number : 8400044 โ€” Miami, Florida
  • Tellabio International Research Services- Site Number : 8400083 โ€” Pembroke Pines, Florida
  • Avanza Medical Research Center- Site Number : 8400056 โ€” Pensacola, Florida
  • Hull and Hull Medical Specialists- Site Number : 8400079 โ€” Plantation, Florida
  • Ilumina Medical Research- Site Number : 8400095 โ€” Saint Cloud, Florida
  • Private Practice - Dr. David Kavtaradze- Site Number : 8400081 โ€” Cordele, Georgia

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Asthma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—