Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03280537 · ClinicalTrials.gov registry record · Phase 3

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
127
Enrollment target

NCT03280537 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 127 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03280537, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
127 participants
Enrollment target

Study Summary

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

Interventions

  • DRUG Placebo
  • DRUG Omalizumab

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2017-11-21
Est. Completion 2019-03-07
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT03280537

The ClinicalTrials.gov registry entry for NCT03280537 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03280537 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03280537 about?

NCT03280537 is a clinical study titled "A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps". The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase I...

What is the current status of trial NCT03280537?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2017-11-21. Estimated completion is 2019-03-07.

What interventions are being tested in trial NCT03280537?

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

Who is sponsoring clinical trial NCT03280537?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.