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NCT02104674 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

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

Completed
Registry status
Phase 3
Development phase
313
Enrollment target

NCT02104674 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 313 participants.

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The verdict

NCT02104674, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
313 participants
Enrollment target

Study Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.

Interventions

  • OTHER placebo
  • DRUG lebrikizumab
  • DRUG montelukast [Singulair]

Trial Details

FieldValue
Enrollment Target 313 participants
Start Date 2014-06
Est. Completion 2016-05
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT02104674

The ClinicalTrials.gov registry entry for NCT02104674 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 313 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 3 interventions - of which placebo is the first listed.

NCT02104674 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02104674 about?

NCT02104674 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma". This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive eith...

What is the current status of trial NCT02104674?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2014-06. Estimated completion is 2016-05.

What interventions are being tested in trial NCT02104674?

The interventions under investigation include: placebo (OTHER), lebrikizumab (DRUG), montelukast [Singulair] (DRUG).

Who is sponsoring clinical trial NCT02104674?

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.