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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 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.

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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.

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

FieldValue
Enrollment Target 335 participants
Start Date 2023-09-05
Est. Completion 2029-06-25
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT06033833

The ClinicalTrials.gov registry entry for NCT06033833 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 335 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (79% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.