NCT04392154

Brief Summary

This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,153

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_3

Geographic Reach
15 countries

318 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 3, 2025

Completed
Last Updated

November 5, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

May 13, 2020

Results QC Date

July 18, 2025

Last Update Submit

October 22, 2025

Conditions

Keywords

EczemaDermatitisDermatitis, AtopicSkin Diseases

Outcome Measures

Primary Outcomes (1)

  • Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events

    Percentage of participants discontinued from study treatment due to adverse events is reported.

    Baseline to Week 100

Secondary Outcomes (2)

  • Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100

    Week 100

  • Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100

    Week 100

Study Arms (4)

Lebrikizumab Q2W (Primary Treatment Period)

EXPERIMENTAL

250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.

Biological: Lebrikizumab

Lebrikizumab Q4W (Primary Treatment Period)

EXPERIMENTAL

250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.

Biological: Lebrikizumab

Open-Label Extension Addendum: Lebrikizumab Q4W

EXPERIMENTAL

250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.

Biological: Lebrikizumab

Open-Label Extension Addendum: Lebrikizumab Q8W

EXPERIMENTAL

250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.

Biological: Lebrikizumab

Interventions

LebrikizumabBIOLOGICAL

Subcutaneous injection

Also known as: LY3650150, DRM06
Lebrikizumab Q2W (Primary Treatment Period)Lebrikizumab Q4W (Primary Treatment Period)Open-Label Extension Addendum: Lebrikizumab Q4WOpen-Label Extension Addendum: Lebrikizumab Q8W

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must meet all the following criteria to be eligible for this study:
  • Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337, NCT04250350 and have adequately completed the study treatments and last patient visit of the parent trial.
  • For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.

You may not qualify if:

  • Participants meeting any of the criteria below will not be included in this study:
  • Participants who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. \*
  • Participants who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. \*
  • Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). \*
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
  • Participants must meet all the following criteria to be eligible for this study addendum:
  • Male or female adults and adolescents (≥12 to \<18 years of age and weighing ≥40 kilogram (kg).
  • Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening.
  • Eczema Area and Severity Index (EASI) score ≥16 at baseline.
  • Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at baseline.
  • ≥10% body surface area (BSA) of AD involvement at baseline.
  • History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
  • Participants meeting any of the criteria below will be excluded from this study addendum:
  • Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
  • History of anaphylaxis
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (321)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Clinical Research Center of Alabama- Birmingham

Birmingham, Alabama, 35244, United States

Location

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, 93309, United States

Location

Wallace Medical Group, Inc.

Beverly Hills, California, 90211, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

MD Studies

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Axon Clinical Research

Inglewood, California, 90301, United States

Location

Sunwise Clinical Research

Lafayette, California, 94549, United States

Location

Avance Clinical Trials Inc

Laguna Niguel, California, 92677, United States

Location

California Allergy and Asthma Medical Group + Research Center

Los Angeles, California, 90025, United States

Location

Keck School of Medicine University of Southern California

Los Angeles, California, 90033, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

LA Universal Research Center, INC

Los Angeles, California, 90057, United States

Location

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

Dermatology Clinical Trials

Newport Beach, California, 92660, United States

Location

Cura Clinical Research

Palmdale, California, 93551, United States

Location

MD Strategies Research Centers MDSRC

Poway, California, 92064, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95825, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

San Diego, California, 92123, United States

Location

Synergy Dermatology

San Francisco, California, 94132, United States

Location

Care Access Research

San Jose, California, 95117, United States

Location

San Luis Dermatology & Laser Clinic

San Luis Obispo, California, 93405, United States

Location

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

Location

IMMUNOe International Research Centers

Centennial, Colorado, 80112, United States

Location

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907-6231, United States

Location

Central Connecticut Dermatology

Cromwell, Connecticut, 06416, United States

Location

Medical Faculty Associates, Inc.

Washington D.C., District of Columbia, 20016, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

Pediatric Skin Research, LLC

Coral Gables, Florida, 33146, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

The University of Florida Health System

Gainesville, Florida, 32606, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

The Community Research of South Florida

Hialeah, Florida, 33016, United States

Location

Encore Medical Research

Hollywood, Florida, 33021, United States

Location

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

Location

GSI Clinical Research, LLC

Margate, Florida, 33063, United States

Location

Vitae Research Center, LLC

Miami, Florida, 33135, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Community Research Foundation Inc

Miami, Florida, 33145, United States

Location

Sanchez Clinical Research Inc

Miami, Florida, 33157, United States

Location

Miami Dermatology and Laser Research

Miami, Florida, 33173, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33173, United States

Location

Florida Research Center, Inc

Miami, Florida, 33174, United States

Location

C & R Research Services USA

Miami Beach, Florida, 33169, United States

Location

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Tory Sullivan, MD PA

North Miami Beach, Florida, 33162, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, 33028, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613-1244, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

University of South Florida College of Medicine

Tampa, Florida, 33620, United States

Location

Georgia Pollens Clinical Research Centers, Inc

Albany, Georgia, 31707, United States

Location

IACT Health - VHC

Columbus, Georgia, 31904, United States

Location

Marietta Dermatology Clinical Research

Marietta, Georgia, 30060, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Georgia Skin & Cancer Clinic

Savannah, Georgia, 31419, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Sneeze, Wheeze, & Itch Associates LLC

Normal, Illinois, 61761, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

Kansas Medical Clinic, an Elligo Health Research, Inc.

Shawnee Mission, Kansas, 66216, United States

Location

Kansas Medical Clinic

Topeka, Kansas, 66614, United States

Location

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Tulane Univ School of Med

New Orleans, Louisiana, 70112, United States

Location

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850, United States

Location

ActivMed Practices and Research

Beverly, Massachusetts, 01915, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Beacon Clinical Research, LLC

Quincy, Massachusetts, 02169, United States

Location

Fivenson Dermatology

Ann Arbor, Michigan, 48103, United States

Location

Oakland Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Michigan Center for Research Company

Clarkston, Michigan, 48346, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St Joseph Dermatology and Vein Clinic

Saint Joseph, Michigan, 49085, United States

Location

Associated Skin Care Specialists

Fridley, Minnesota, 55432, United States

Location

Associated Skin Care Specialists

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Central Dermatology PC

St Louis, Missouri, 63117, United States

Location

Advanced Dermatology of the Midlands

Omaha, Nebraska, 68144, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

ALLCUTIS Research

Portsmouth, New Hampshire, 03801, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

JUVA Skin & Laser Center

New York, New York, 10022-3350, United States

Location

Icahn Sch of Med at Mt. Sinai

New York, New York, 10029, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Advanced Asthma and Allergy

Watertown, New York, 13601, United States

Location

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Medication Management

Greensboro, North Carolina, 27408, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Central States Research

Tulsa, Oklahoma, 74136, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Crisor, LLC, Medford office

Medford, Oregon, 97504, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

OHSU Center for Health and Healing

Portland, Oregon, 97239, United States

Location

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, 19341, United States

Location

Paddington Testing Company Inc

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

DermDox Dermatology Centers

Sugarloaf, Pennsylvania, 18249, United States

Location

Peak Research LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

AAPRI Clinical Research Institute

Warwick, Rhode Island, 02886, United States

Location

Palmetto Clinical Trial Services, LLC

Anderson, South Carolina, 29621, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Rivergate Dermatology Clinical Research Center PL

Goodlettsville, Tennessee, 37072, United States

Location

Arlington Research Center, Inc

Arlington, Texas, 76011, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Austin Institute for Clinical Research

Dripping Springs, Texas, 78620, United States

Location

Innovate Research, LLC

Fort Worth, Texas, 76244, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

Encore Imaging & Medical Research

Houston, Texas, 77065, United States

Location

Cutis Wellness Dermatology

Laredo, Texas, 78041, United States

Location

Laredo Dermatology Associates P.A.

Laredo, Texas, 78041, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Acclaim Dermatology PLLC

Sugar Land, Texas, 77479, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

University of Utah MidValley Dematology

Murray, Utah, 84107, United States

Location

Velocity Clinical Research - Woseth Dermatology

Salt Lake City, Utah, 84117, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

Location

The Skin Hospital

Darlinghurst, New South Wales, 02010, Australia

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

The St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Skin & Cancer Foundation Australia

Westmead, New South Wales, 2045, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

University of the Sunshine Coast Clinical Trial Centre

Sippy Downs, Queensland, 04556, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Clinical Trials SA Pty Ltd

Hectorville, South Australia, 5073, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Skin Health Institute Inc.

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology

Melbourne, Victoria, 3002, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 03050, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Burswood Dermatology

Victoria Park, Western Australia, 06100, Australia

Location

Captain Stirling Medical Centre

Nedlands, 6009, Australia

Location

DCC Sveti Georgi

Haskovo, 6300, Bulgaria

Location

Diagnostic and Consultation Center 14

Sofia, 1408, Bulgaria

Location

Alexandrovska University Hospital

Sofia, 1431, Bulgaria

Location

Euro Derma clinic

Sofia, 1606, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Medical centre Alitera-Med EOOD

Sofia, 1618, Bulgaria

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

CARe Clinic

Red Deer, Alberta, T4P1K4, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

University of British Columbia

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S7K8, Canada

Location

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Skin Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

North York Research Inc.

North York, Ontario, M2M4J5, Canada

Location

The Centre for Clinical Trials, Inc

Oakville, Ontario, L6J7W5, Canada

Location

Ottawa Allergy Research Corp

Ottawa, Ontario, K1G 6C6, Canada

Location

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2, Canada

Location

Skin Health

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

AvantDerm

Toronto, Ontario, M5A3R6, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

International Dermatology Research

Montreal, Quebec, H3H1V4, Canada

Location

International Dermatology Research

Montreal, Quebec, H4A 3J1, Canada

Location

Vahlberg & Pild OU

Talinn, 10134, Estonia

Location

Kliiniliste uuringute Keskus OU

Tartu, 50160, Estonia

Location

Tartu University Hospital

Tartu, 51417, Estonia

Location

CHU de Bordeaux Hop St ANDRE

Bordeaux, Gironde, 33075, France

Location

CHRU de Brest - Hôpital Morvan

Brest, 29200, France

Location

CHU Dijonon

Dijon, 21079, France

Location

CHD Vendee

La Roche-sur-Yon, 85000, France

Location

Cabinet Médical

Martigues, 13500, France

Location

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093, France

Location

CHU de Nice Hopital de L'Archet

Nice, 06202, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Larrey

Toulouse, 31059, France

Location

Studienzentrum Dr.Beate Schwarz

Langenau, Baden-Wurttemberg, 89129, Germany

Location

Hautarztpraxis am Löwenmarkt

Stuttgart, Baden-Wurttemberg, 70499, Germany

Location

Dermazentrum Augsburg

Augsburg, Bavaria, 86179, Germany

Location

Rosenpark Research GmbH

Darmstadt, Hesse, 64283, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60596, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

Klinische Forschung Osnabrück

Osnabrück, Lower Saxony, 49074, Germany

Location

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, 44793, Germany

Location

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, 48149, Germany

Location

Company for Medical Study & Service Selters GmbH

Selters, Rhineland-Palatinate, 56242, Germany

Location

Hautarztpraxis Dr. Gerlach

Dresden, Saxony, 01097, Germany

Location

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

Dresden, Saxony, 01307, Germany

Location

Universität Leipzig - Universitätsklinikum

Leipzig, Saxony, 04103, Germany

Location

Velocity Clinical Research Leipzig GmbH

Leipzig, Saxony, 04103, Germany

Location

SRH Wald-Klinikum Gera

Gera, Thuringia, 07548, Germany

Location

Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD

Augsburg, 86150, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 10117, Germany

Location

ISA GmbH

Berlin, 10789, Germany

Location

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, 13055, Germany

Location

Dermatologikum Hamburg

Hamburg, 20144, Germany

Location

TFS Trial Support Form GmbH

Hamburg, 20537, Germany

Location

Clinic of Dermatology and STD

Riga, LV-1001, Latvia

Location

Health and Aesthetics LTD

Riga, LV-1009, Latvia

Location

Latvian Dermatology Institute

Riga, LV-1011, Latvia

Location

Health Center 4, Affiliate Diagnostic Center

Riga, LV1003, Latvia

Location

Smite Aija - Doctor Practice in Dermatology Venereology

Talsi, LV-3201, Latvia

Location

JSC "CD8 Alergology Clinic"

Kaunas, LT-44192, Lithuania

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, LT-50161, Lithuania

Location

Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

Vilnius, 08406, Lithuania

Location

Jsc Renmeda

Vilnius, LT-07195, Lithuania

Location

JSC "Center for Diagnosis and Treatment of Allergic Diseases"

Vilnius, LT-08109, Lithuania

Location

JSC Inlita (Santaros CTC)

Vilnius, LT-08406, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08441, Lithuania

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, Federal District, 06720, Mexico

Location

Grupo Clinico CATEI Sociedad Civil

Guadalajara, Jalisco, 44657, Mexico

Location

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, Michoacán, 58249, Mexico

Location

Cemdeicy S.C.P.

Mérida, Yucatán, 97130, Mexico

Location

Derma Norte del Bajio

Aguascalientes, 20130, Mexico

Location

Arke Estudios Clinicos S.A. de C.V.

Veracruz, 91910, Mexico

Location

Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Diamond Clinic

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

dermMedica Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

Location

Centralny Szpital Kliniczny MSWiA

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, 02-625, Poland

Location

Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Labderm s.c.

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Clinica Vitae Sp. z o.o.

Gdansk, Woj. Pomorskie, 80-344, Poland

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

Bialystok, 15-369, Poland

Location

Wojewodzki Szpital Zespolony

Elblag, 82-300, Poland

Location

Oddzial Dermatologii COPERNICUS

Gdansk, 80-462, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdynia, 81-553, Poland

Location

Holsamed

Katowice, 40-600, Poland

Location

Holsamed

Katowice, 40-851, Poland

Location

Gabinet Dermatlogiczny. Beata Krecisz

Kielce, 25-155, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

Lublin, 20-081, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

Rzeszów, 35-055, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71 500, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

Tarnów, 33-100, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, 01-142, Poland

Location

High-Med Prywatny Gabinet Lekarski

Warsaw, 01-817, Poland

Location

MTZ Clinical Research Sp.z.o.o.

Warsaw, 02-106, Poland

Location

Klinika Ambroziak Sp. Z.O.O.

Warsaw, 02-953, Poland

Location

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, 50-566, Poland

Location

Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland

Location

National University Hospital

Singapore, Central Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169078, Singapore

Location

Kk Women'S and Childrens Hospital

Singapore, 229899, Singapore

Location

National Skin Centre NSC

Singapore, 308205, Singapore

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Pusan National University Hospital

Busan, Korea, 49241, South Korea

Location

Hanyang University Medical Center

Seoul, Korea, 04763, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Incheon St. Mary's Hospital

Incheon, 21431, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 8950, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Catalunya [Cataluña], 08916, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Basurto

Bilbao (Bizkaia), 48013, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Niaosong, Kaohsiung City, 833, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan, 33305, Taiwan

Location

Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

Poshtova Square 2, Zaporizhzhya, 69063, Ukraine

Location

Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

Kharkiv, 61038, Ukraine

Location

SE "Institute of Dermatology and Venerology of NAMS of Ukraine"

Kharkiv, 61057, Ukraine

Location

Rivne Regional Dermatology and Venereology Dispensary

Rivne, 33028, Ukraine

Location

Treatment-diagnostic center PE "Asclepius"

Uzhhorod, 88000, Ukraine

Location

Related Publications (2)

  • Silverberg JI, Wollenberg A, Stein Gold L, Yosipovitch G, Lio P, Vestergaard C, Stander S, Carrascosa JM, Gallo G, Casillas M, Ding Y, Yang FE, Pierce E, Agell H, Del Rosso J. Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis. Clin Exp Dermatol. 2025 Nov 8:llaf490. doi: 10.1093/ced/llaf490. Online ahead of print.

  • Guttman-Yassky E, Weidinger S, Simpson EL, Gooderham M, Irvine AD, Spelman L, Silverberg JI, ElMaraghy H, DeLuca-Carter L, Piruzeli MLB, Hu C, Yang FE, Pierce E, Bardolet L, Thaci D. Two-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin). Dermatol Ther (Heidelb). 2025 Aug;15(8):2217-2232. doi: 10.1007/s13555-025-01452-9. Epub 2025 Jun 23.

MeSH Terms

Conditions

Dermatitis, AtopicEczemaDermatitisSkin Diseases

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 18, 2020

Study Start

June 15, 2020

Primary Completion

July 19, 2024

Study Completion

April 22, 2025

Last Updated

November 5, 2025

Results First Posted

August 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations