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Clinical Trial Details for Evaluation of the Safety and Efficacy of Lebrikizumab in Combination With Topical Corticosteroid in Moderate to Severe Atopic Dermatitis.


Dermira, Inc.
NCT ID: NCT04250337
Last Updated: January 30, 2020

The Study at a Glance

  • Status: Not yet recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 12 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Dermira, Inc.
  • Location: Not Provided

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis

Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

1. Male or female adult and adolescents (≥12 years to 17 years, and weighing ≥40 kg).

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has
been present for ≥1 year before the screening visit.

3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

6. History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.

2. Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or within 5 half-lives (if known),
whichever is longer.

2. Dupilumab within 8 weeks.

3. Cell-depleting biologics, including to rituximab, within 6 months.

4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study.

4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

5. Evidence of active acute or chronic hepatitis

6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
screening.

7. History of malignancy, including mycosis fungoides, within 5 years before the
screening visit, except completely treated in situ carcinoma of the cervix, completely
treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Dermira, Inc.

Investigators

Study Director: Kate Doherty

Dermira, Inc.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04250337

Location

Contacts

Site 6004

Beverly Hills, California 90211

United States

Wallace Medical Group Inc.

Site 6019

Fountain Valley, California 92708

United States

First OC Dermatology

Site 6003

Los Angeles, California 90045

United States

Dermatology Research Associates

Site 6011

Hialeah, Florida 33012

United States

Direct Helpers Research Center

Site 6066

Hialeah, Florida 33016

United States

The Community Research of South Florida

Site 6021

Tampa, Florida 33624

United States

Forward Clinical Trials Inc.

Site 6014

Plainfield, Indiana 46168

United States

The Indiana Clinical Trials Center

Site 6007

Beverly, Massachusetts 01915

United States

ActivMed Practices and Research Inc.

Site 6015

Clarkston, Michigan 48346

United States

Clarkston Skin Research

Site 6001

Portsmouth, New Hampshire 03801

United States

ALLCUTIS Research

Site 6002

New York, New York 10075

United States

Sadick Research Group

Site 6005

Medford, Oregon 97504

United States

Crisor LLC

Site 6009

Arlington, Texas 76011

United States

Arlington Research Center Inc.

Site 6017

Friedrichshafen, Baden-Wuerttemberg 88045

Germany

Derma-Study-Center-Friedrichshafen Dr. med. Peter Radny

Site 6013

Witten, Deutschland 58454

Germany

Hautarztpraxis Dr. med. Matthias Hoffmann

Site 6018

Darmstadt, Hessen 64283

Germany

Rosenpark Research, Rosenparkklinik GmbH

Site 6022

Frankfurt am Main, Hessen 60590

Germany

Klinikum der J.W. Goethe-Universitaet

Site 6008

Buxtehude, Lower Saxony 21614

Germany

Elbe Klinikum Buxtehude Klinik für Dermatologie

Site 6024

Osnabrück, Lower Saxony 94074

Germany

KliFOs - Klinische Forschung Osnabrueck

Site 6023

Hamburg, 20537

Germany

TFS Trial Support Form GmbH

Site 6012

Tarnów, Malopolska 33-100

Poland

ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA SP Z O.O.

Site 6016

Rzeszów, Podkarpackie 35-055

Poland

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

Site 6020

Kielce, Swietokrzyskie 25-155

Poland

Gabinet Dermatlogiczny. Beata Krecisz