MedTrace Logo

A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

NCT02340234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2017-10-02

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

Conditions

Interventions

DRUG

Lebrikizumab

Lebrikizumab will be administered SC as per the schedule specified in the respective arms.

DRUG

Placebo

Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.

DRUG

TCS Cream

TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

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
2015-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • 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 NCT02340234 on ClinicalTrials.gov