MedTrace Logo

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

NCT02104674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2026-07-17

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Lebrikizumab

Lebrikizumab 125 mg subcutaneous (SC) injection given on Days 1, 29, and 57

DRUG

Montelukast

10 mg tablet given orally once daily for 12 weeks, according to the approved label.

OTHER

Placebo

Lebrikizumab-matched placebo SC injection given on Days 1, 29, and 57

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-07
Primary Completion
2016-01-22
Completion
2016-01-22

Countries

  • United States
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02104674 on ClinicalTrials.gov