MedTrace Logo

A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

NCT05149313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2025-05-20

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

Conditions

Interventions

BIOLOGICAL

Lebrikizumab

Lebrikizumab solution for injection administered subcutaneously.

DRUG

Lebrikizumab-matching Placebo

Matching Placebo solution for injection administered subcutaneously.

Sponsors & Collaborators

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Study Director · Almirall, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2023-01-30
Completion
2024-05-07
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05149313 on ClinicalTrials.gov