🏛️ Verified NIH Record • Updated 2026-05-18

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (NCT06033833)

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Who can join: Review the eligibility criteria below.

Location: Bensch Research Associates- Site Number : 8400004 — Stockton, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (68 Sites)

Showing the first 25 of 68 sites.

  • Bensch Research Associates- Site Number : 8400004 — Stockton, California
  • Helix Biomedics- Site Number : 8400029 — Boynton Beach, Florida
  • Savin Medical Group - Miami Lakes- Site Number : 8400015 — Miami Lakes, Florida
  • Pines Care Research Center- Site Number : 8400028 — Pembroke Pines, Florida
  • Treasure Valley Medical Research- Site Number : 8400031 — Boise, Idaho
  • Johns Hopkins Bayview Medical Center- Site Number : 8400012 — Baltimore, Maryland
  • OK Clinical Research- Site Number : 8400001 — Edmond, Oklahoma
  • South Texas Medical Research Institute - TTS Research- Site Number : 8400011 — Boerne, Texas
  • Investigational Site Number : 0320008 — La Plata, Buenos Aires
  • Investigational Site Number : 0320005 — Rosario, Santa Fe Province
  • Investigational Site Number : 0320006 — Rosario, Santa Fe Province
  • Investigational Site Number : 0320007 — Rosario, Santa Fe Province
  • Investigational Site Number : 0320004 — Buenos Aires,
  • Investigational Site Number : 0320003 — Buenos Aires,
  • Investigational Site Number : 0320001 — Buenos Aires,
  • Investigational Site Number : 0320002 — Buenos Aires,
  • Investigational Site Number : 0320009 — Buenos Aires,
  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002 — Vitória, Espírito Santo
  • Associacao Proar- Site Number : 0760004 — Salvador, Estado de Bahia
  • Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001 — Passo Fundo, Rio Grande do Sul
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007 — Porto Alegre, Rio Grande do Sul
  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006 — Porto Alegre, Rio Grande do Sul
  • Clinica de Alergia Martti Antila- Site Number : 0760003 — Sorocaba, São Paulo
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008 — São Paulo,
  • Investigational Site Number : 1240008 — Ottawa, Ontario

💰 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 § 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

💡 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.
🏛️ View Official NIH Record ↗