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NCT06033833 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Asthma, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 335
- Enrollment target
- 20
- Study locations
NCT06033833: Active Phase 2 study of Asthma, sponsored by Sanofi.
NCT06033833 is a Phase 2 study of Asthma that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 335 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06033833, a Phase 2 study of Asthma, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 335 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of participants with treatment emergent Adverse Events.
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 |
What the registry record for NCT06033833 still lists
NCT06033833 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (79% lower).
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.
NCT06033833 names 20 study sites across 13 states, led by Florida, Santa Fe Province, Other.
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.
What interventions are being tested in trial NCT06033833?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT06033833?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
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.
Where NCT06033833's enrollment target sits among peer trials
335 115th of 374 higher than 260 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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