Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
Study Locations (20)
Florida
- Helix Biomedics, LLC - Site Number : 8400029 — Boynton Beach
- Savin Medical Group - Miami- Site Number : 8400015 — Miami
- Pines Care Research Center LLC- Site Number : 8400028 — Pembroke Pines
Santa Fe Province
- Investigational Site Number : 0320006 — Rosario
- Investigational Site Number : 0320007 — Rosario
- Investigational Site Number : 0320005 — Rosario
Other
- Investigational Site Number : 0320004 — Ciudad Autonoma Bs As
- Investigational Site Number : 0320003 — Ciudad Autonoma Buenos Aires
- Investigational Site Number : 0320001 — Ciudad Autonoma Buenos Aires
Buenos Aires
- Investigational Site Number : 0320002 — CABA
- Investigational Site Number : 0320008 — La Plata
California
- Bensch Clinical Research LLC- Site Number : 8400004 — Stockton
Idaho
- Treasure Valley Medical Research- Site Number : 8400031 — Boise
Maryland
- Johns Hopkins University School of Medicine- Site Number : 8400012 — Baltimore
Oklahoma
- OK Clinical Research, LLC- Site Number : 8400001 — Edmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2029-06-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06033833
The ClinicalTrials.gov registry entry for NCT06033833 describes a study currently listed as active not 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 335 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 2 interventions — of which Placebo 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: NCT06033833 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Santa Fe Province, Other. 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 NCT06033833 about?
NCT06033833 is a clinical study titled "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". 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. ...
What is the current status of trial NCT06033833?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 335 participants. The study started on 2023-09-05. Estimated completion is 2029-06-25.
What conditions does trial NCT06033833 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 NCT06033833?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06033833?
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 NCT06033833 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Maryland, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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