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RECRUITING 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

NCT05097287 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 4, 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 1,324 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: NCT05097287 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05097287?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05097287?

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 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.

Related

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