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NCT05097287 · ClinicalTrials.gov registry record · Phase 4

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

A Phase 4 study of Asthma, sponsored by Sanofi.

Recruiting
Registry status
Phase 4
Development phase
1,324
Enrollment target
20
Study locations

NCT05097287: Recruiting Phase 4 study of Asthma, sponsored by Sanofi.

NCT05097287 is a Phase 4 study of Asthma that is actively recruiting participants, run by Sanofi. The registered enrollment target is 1,324 participants, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05097287, a Phase 4 study of Asthma, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 4
Development phase
1,324 participants
Enrollment target
20
Study locations

Study Summary

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Primary Outcome

Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.

Conditions Studied

Asthma

Interventions

  • DRUG Placebo
  • DRUG Dupilumab

Study Locations (20)

California

  • Kern Allergy and Medical Research- Site Number : 8400037 - Bakersfield
  • Vitality Clinical Research- Site Number : 8400142 - Beverly Hills
  • Ascada Research - Fullerton- Site Number : 8400076 - Fullerton
  • Allergy and Asthma Specialists Medical Group- Site Number : 8400162 - Huntington Beach
  • Newport Native MD- Site Number : 8400054 - Newport Beach
  • Prospective Research Innovations- Site Number : 8400131 - Rancho Cucamonga
  • Mercy Medical Group - Midtown- Site Number : 8400164 - Sacramento
  • Integrated Research of Inland- Site Number : 8400156 - Upland
  • Allianz Research Institute- Site Number : 8400018 - Westminster
  • Woodland Clinic - Woodland- Site Number : 8400171 - Woodland

Arizona

  • Chandler Clinical Research Trials- Site Number : 8400147 - Chandler
  • Pulmonary Associates - Deer Valley Office- Site Number : 8400155 - Phoenix
  • Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130 - Phoenix
  • Del Sol Research Management - Tucson- Site Number : 8400017 - Tucson

Florida

  • Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035 - Altamonte Springs
  • Florida Center for Allergy & Asthma Research- Site Number : 8400032 - Aventura
  • Beautiful Minds Clinical Research Center- Site Number : 8400141 - Cutler Bay
  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023 - DeBary

Alabama

  • Cullman Research Center- Site Number : 8400001 - Cullman
  • Shoals Primary Care - Sheffield- Site Number : 8400015 - Sheffield

Trial Details

FieldValue
Enrollment Target 1,324 participants
Start Date 2021-12-16
Est. Completion 2029-08-21
Phase Phase 4
Sanofi

713 total trials

What NCT05097287 shows while recruiting

NCT05097287 is an interventional study that assigns participants to a tested intervention. Its 1,324 participants enrollment target places it among the larger protocols in the corpus, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (15% 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.

NCT05097287 names 20 study sites across 4 states, led by California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT05097287 about?

NCT05097287 is a clinical study titled "Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma". This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. Th...

What is the current status of trial NCT05097287?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,324 participants. The study started on 2021-12-16. Estimated completion is 2029-08-21.

What conditions does trial NCT05097287 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT05097287?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).

Who is sponsoring clinical trial NCT05097287?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05097287 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida. 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 NCT05097287's enrollment target sits among peer trials

1,324 30th of 374 higher than 345 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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More recruiting context for NCT05097287

Source: ClinicalTrials.gov NCT05097287, the US trial registry maintained by the National Library of Medicine. NCT05097287 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.