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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,324 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2029-08-21 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05097287
The ClinicalTrials.gov registry entry for NCT05097287 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 1,324 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (15% 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.
NCT05097287 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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