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

NCT05097287 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1339

Last updated 2026-04-16

No results posted yet for this 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

Interventions

DRUG

Dupilumab

solution for injection subcutaneous

DRUG

Placebo

solution for injection subcutaneous

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2027-03-16
Completion
2029-06-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Greece
  • Hungary
  • India
  • Ireland
  • Mexico
  • Oman
  • Peru
  • Puerto Rico
  • Romania
  • Saudi Arabia
  • Slovakia
  • South Africa
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097287 on ClinicalTrials.gov