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NCT02528214 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
210
Enrollment target

NCT02528214: Completed Phase 3 study, sponsored by Sanofi.

NCT02528214 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 210 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02528214, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
210 participants
Enrollment target

Study Summary

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab in improving participants-reported outcomes. * To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Primary Outcome

Percentage reduction of OCS dose was calculated as (optimized OCS dose \[mg/day\] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.

Interventions

  • DRUG Placebo
  • DRUG Dupilumab
  • DRUG Inhaled corticosteroid (ICS) therapy
  • DRUG Albuterol/Salbutamol
  • DRUG Oral corticosteroid therapy (prednisone/prednisolone)

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2015-10-15
Est. Completion 2017-11-13
Phase Phase 3
Sanofi

713 total trials

What the finished NCT02528214 record still lists

NCT02528214 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02528214 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02528214 about?

NCT02528214 is a clinical study titled "Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma". Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the eff...

What is the current status of trial NCT02528214?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2015-10-15. Estimated completion is 2017-11-13.

What interventions are being tested in trial NCT02528214?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Inhaled corticosteroid (ICS) therapy (DRUG), Albuterol/Salbutamol (DRUG), Oral corticosteroid therapy (prednisone/prednisolone) (DRUG).

Who is sponsoring clinical trial NCT02528214?

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

How this trial's enrollment target compares

Where NCT02528214's enrollment target sits among peer trials

210 1338th of 2000 higher than 656 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT02528214, the US trial registry maintained by the National Library of Medicine. NCT02528214 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.