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Clinical Trial Details for Evaluation of the Efficacy and Safety of Lebrikizumab in Moderate to Severe Atopic Dermatitis


Dermira, Inc.
NCT ID: NCT04178967
Last Updated: January 23, 2020

The Study at a Glance

  • Status: 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 in Patients With Moderate to Severe Atopic Dermatitis.

Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

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 adults and adolescents (≥12 years and ≥40 kg).

2. Chronic atopic dermatitis (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 atopic dermatitis 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. Prior treatment with dupilumab or tralokinumab.

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

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

2. Cell-depleting biologics, including to rituximab, within 6 months of baseline.

3. Other biologics within 5 half-lives (if known) or 16 weeks of baseline, 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, e.g.,
co-morbid severe uncontrolled asthma.

5. Evidence of active acute or chronic hepatitis

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

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: NCT04178967

Location

Contacts

Site 5017

Scottsdale, Arizona 85255

United States

Investigate MD

Site 5028

Rogers, Arkansas 72758

United States

Northwest Arkansas Clinical Trials Center

Site 5026

Bakersfield, California 93309

United States

Bakersfield Dermatology Skin Cancer Med Group

Site 5001

Fremont, California 94538

United States

Center for Dermatology Clinical Research Inc.

Site 5006

Fresno, California 93720

United States

Site 5014

Los Angeles, California 90057

United States

LA Universal Research Center Inc.

Site 5027

San Luis Obispo, California 93405

United States

San Luis Dermatology and Laser Clinic

Site 5025

Fort Myers, Florida 33912

United States

Site 5016

Hialeah, Florida 33012

United States

Direct Helpers Research Center

Site 5010

Jacksonville, Florida 32256

United States

Solutions through Advanced Research Inc.

Site 5030

Albany, Georgia 31707

United States

Georgia Pollens Clinical Research Centers Inc.

Site 5007

Marietta, Georgia 30060

United States

Marietta Dermatology Clinical Research Inc.

Site 5032

Sandy Springs, Georgia 30328

United States

Advanced Medical Research

Site 5009

Overland Park, Kansas 66215

United States

Kansas City Dermatology P.A.

Site 5029

Baton Rouge, Louisiana 70808

United States

Meridian Clinical Research

Site 5024

Lake Charles, Louisiana 70601

United States

Clinical Trials of SWLA LLC

Site 5002

Beverly, Massachusetts 01915

United States

ActivMed Practices and Research Inc.

Site 5031

Boston, Massachusetts 02111

United States

Tuffs Medical Center

Site 5131

Boston, Massachusetts 02111

United States

Site 5019

Bay City, Michigan 48706

United States

Great Lakes Research Group Inc.

Site 5023

Clarkston, Michigan 48346

United States

Clarkston Skin Research

Site 5033

Fridley, Minnesota 55432

United States

Minnesota Clinical Study Center

Site 5011

Kew Gardens, New York 11375

United States

Forest Hills Dermatology Group

Site 5004

Charlotte, North Carolina 28277

United States

OnSite Clinical Solutions

Site 5013

Wilmington, North Carolina 28405

United States

Wilmington Dermatology Center

Site 5020

Exton, Pennsylvania 19341

United States

Schwager Dermatology Group

Site 5012

Sugarloaf, Pennsylvania 18249

United States

DermDocs Center for Dermatology

Site 5021

Upper Saint Clair, Pennsylvania 15241

United States

PEAK Research LLC

Site 5008

Charleston, South Carolina 29407

United States

Clinical Research of the Carolinas

Site 5005

Arlington, Texas 76011

United States

Arlington Research Center Inc.

Site 5022

Fort Worth, Texas 76244

United States

Innovate Research LLC

Site 5003

Pflugerville, Texas 78660

United States

Austin Institute for Clinical Research Inc.

Site 5034

Murray, Utah 84107

United States

University of Utah MD Valley

Site 5015

Norfolk, Virginia 23502

United States

Virginia Clinical Research Inc.

Site 5018

Seattle, Washington 98101

United States

Dermatology Associates of Seattle

Site 5115

Haskovo, 6300

Bulgaria

Site 5101

Sofia, 1408

Bulgaria

Site 5119

Sofia, 1431

Bulgaria

Site 5116

Sofia, 1606

Bulgaria

Site 5118

Sofia, 1606

Bulgaria

Site 5037

Surrey, British Columbia V3R 6A7

Canada

Site 5040

Barrie, Ontario L4M 7G1

Canada

Site 5036

North York, Ontario M2M 4J5

Canada

Site 5039

Ottawa, Ontario K1G 6C6

Canada

Site 5041

Waterloo, Ontario N1J1C4

Canada

Site 5038

Windsor, Ontario N8W 1E6

Canada

Site 5129

Aachen, 52074

Germany

Site 5127

Augsburg, 86150

Germany

Site 5136

Augsburg, 86179

Germany

Site 5137

Bad Bentheim, 48455

Germany

Site 5135

Baden, 70449

Germany

Site 5121

Berlin, 10117

Germany

Site 5105

Berlin, 10789

Germany

Site 5130

Berlin, 13055

Germany

Site 5123

Berlin, 13507

Germany

Site 5126

Buxtehude, 21614

Germany

Site 5134

Darmstadt, 64283

Germany

Site 5133

Dresden, 01097

Germany

Site 5122

Friedrichshafen, 88045

Germany

Site 5132

Gera, 07548

Germany

Site 5102

Hamburg, 20144

Germany

Site 5139

Hamburg, 20537

Germany

Site 5106

Heidelberg, 69120

Germany

Site 5131

Langenau, 89129

Germany

Site 5103

Leipzig, 04103

Germany

Site 5104

Lübeck, 23562

Germany

Site 5125

Munich, 80802

Germany

Site 5138

Münster, 48149

Germany

Site 5128

Osnabrück, 49074

Germany

Site 5146

L'Aquila, 67100

Italy

Site 5145

Milano, 20161

Italy

Site 5147

Perugia, 06129

Italy

Site 5148

Roma, 168

Italy

Site 5149

Rozzano, 20089

Italy

Site 5207

Guadalajara, 44657

Mexico

Site 5206

Mexico City, 6720

Mexico

Site 5202

Mérida, CP97130

Mexico

Site 5203

Zaragoza, CP91910

Mexico

Site 5108

Braşov, 500051

Romania

Site 5143

Bucharest, 11234

Romania

Site 5141

Bucharest,

Romania

Site 5140

Cluj-Napoca,

Romania

Site 5107

Craiova, 200061

Romania

Site 5312

Singapore, 119074

Singapore

Site 5313

Singapore, 229899

Singapore

Site 5311

Singapore, 30825

Singapore

Site 5314

Singapore, 5314

Singapore

Site 5306

Kaohsiung, 807

Taiwan

Site 5302

Kaohsiung, 83301

Taiwan

Site 5304

Taichung City, 40201

Taiwan

Site 5305

Taichung, 404

Taiwan

Site 5307

Taipei City, 23561

Taiwan

Site 5303

Taipei, 10048

Taiwan

Site 5111

Kharkiv, 61038

Ukraine

Site 5112

Rivne, 33028

Ukraine

Site 5110

Uzhhorod, 88000

Ukraine

Site 5109

Zaporizhia, 69063

Ukraine