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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: NCT04146363
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: NCT04146363

Location

Contacts

Site 4021

Fort Smith, Arkansas 72916

United States

Johnson Dermatology

Site 4013

Beverly Hills, California 90211

United States

Wallace Medical Group Inc.

Site 4031

Encinitas, California 92024

United States

California Dermatology & Clinical Research Institute

Site 4014

Fountain Valley, California 92708

United States

First OC Dermatology

Site 4026

Los Angeles, California 90045

United States

Dermatology Research Associates

Site 4020

Mission Viejo, California 92691

United States

Allergy Asthma Associates of Southern California

Site 4023

San Diego, California 92119

United States

MD Strategies Research Center MDSRC

Site 4027

Cromwell, Connecticut 06414

United States

Central Connecticut Dermatology

Site 4008

Clearwater, Florida 33765

United States

St. Francis Medical Institute

Site 4005

Miami, Florida 33145

United States

Floridian Research Institute LLC

Site 4030

North Miami Beach, Florida 33162

United States

Sullivan Dermatology

Site 4009

Tampa, Florida 33613

United States

ForCare Clinical Research

Site 4017

Columbus, Georgia 31904

United States

IACT Health

Site 4004

Plainfield, Indiana 46168

United States

The Dermatology Center of Indiana

Site 4002

Louisville, Kentucky 40217

United States

Skin Sciences PLLC

Site 4006

Quincy, Massachusetts 02169

United States

Beacon Clinical Research LLC

Site 4025

Detroit, Michigan 48202

United States

Henry Ford Hospital

Site 4028

Saint Joseph, Michigan 49085

United States

Saint Joseph Dermatology and Vein Clinic

Site 4015

Saint Joseph, Missouri 64506

United States

MediSearch Clinical Trials

Site 4018

Las Vegas, Nevada 89148

United States

JDR Dermatology Research

Site 4003

Portsmouth, New Hampshire 03801

United States

ActivMed Practices and Research Inc.

Site 4007

New York, New York 10029

United States

Icahn School of Medicine at Mt. Sinai

Site 4010

New York, New York 10075

United States

Sadick Research Group

Site 4029

Rochester, New York 14620

United States

University of Rochester Dermatology CTU

Site 4019

Raleigh, North Carolina 27612

United States

M3 Wake Research, Inc.

Site 4022

Oklahoma City, Oklahoma 73112

United States

Lynn Health Science Institute

Site 4011

Tulsa, Oklahoma 74136

United States

Vital Prospects Clinical Research Institute, P.C.

Site 4024

Medford, Oregon 97504

United States

Crisor, LLC, Medford Office

Site 4001

Portland, Oregon 97223

United States

Oregon Medical Research Center

Site 4032

Johnston, Rhode Island 02919

United States

Clinical Partners LLC

Site 4033

Bellaire, Texas 77401

United States

Bellaire Dermatology Associates

Site 4016

San Antonio, Texas 78213

United States

Progressive Clinical Research P.A.

Site 4012

Spokane, Washington 99202

United States

Premier Clinical Research LLC

Site 4023

Benowa, Queensland 4217

Australia

Site 4205

Woolloongabba, Queensland 4102

Australia

Site 4202

Melbourne, Victoria

Australia

Site 4206

Fremantle, Western Australia 6160

Australia

Site 4215

Victoria Park, Western Australia 6100

Australia

Site 4040

Ajax, Ontario L1A 7K8

Canada

Site 4036

Ottawa, Ontario K2C 3N2

Canada

Site 4106

Tallinn, 10134

Estonia

Site 4123

Tartu, 50160

Estonia

Site 4124

Tartu, 50417

Estonia

Site 4134

Bordeaux, 33075

France

Site 4130

Dijon cedex, 21079

France

Site 4131

Toulouges Cedex, 31059

France

Site 4213

Busan, 49241

Korea, Republic of

Site 4207

Gyeonggi-do, 15355

Korea, Republic of

Site 4218

Gyeonggi-do, 41584

Korea, Republic of

Site 4219

Gyeonggi-do, 61499

Korea, Republic of

Site 4221

Incheon, 21431

Korea, Republic of

Site 4208

Seoul, 03722

Korea, Republic of

Site 4222

Seoul, 04763

Korea, Republic of

Site 4209

Seoul, 05505

Korea, Republic of

Site 4217

Seoul, 06973

Korea, Republic of

Site 4214

Seoul, 07441

Korea, Republic of

Site 4108

Riga, LV-1001

Latvia

Site 4109

Riga, LV-1009

Latvia

Site 4103

Riga, LV-1011

Latvia

Site 4105

Talsi, LV-3201

Latvia

Site 4126

Kaunas, LT-50161

Lithuania

Site 4118

Vilnius, LT-07195

Lithuania

Site 4124

Vilnius, LT-08109

Lithuania

Site 4127

Vilnius, LT-08406

Lithuania

Site 4133

Vilnius, LT-08406

Lithuania

Site 4125

Vilnius, LT-08441

Lithuania

Site 4116

Alicante, 03010

Spain

Site 4136

Barcelona, 08036

Spain

Site 4137

Barcelona, 08950

Spain

Site 4135

Bilbao, 48013

Spain

Site 4114

Madrid, 28031

Spain

Site 4129

Sevilla, 41009

Spain