Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

NCT ID: NCT04392154

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2025-04-22

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.

Detailed Description

Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.

This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.

This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open-Label Extension Addendum: Lebrikizumab Q8W

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

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Subcutaneous injection

Lebrikizumab Q2W (Primary Treatment Period)

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

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Subcutaneous injection

Lebrikizumab Q4W (Primary Treatment Period)

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

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Subcutaneous injection

Open-Label Extension Addendum: Lebrikizumab Q4W

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

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Subcutaneous injection

Interventions

Lebrikizumab

Subcutaneous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

LY3650150; DRM06

Eligibility Criteria

Inclusion Criteria

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.

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.

Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.

Exclusion Criteria

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 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
• Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
• Treatment with any of the following agents within 4 weeks prior to the baseline.

• Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy and photochemotherapy (PUVA) for AD.
• Treatment with the following prior to baseline:

• Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy and photochemotherapy (PUVA) for AD.
• Treatment with the following prior to baseline:

• An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
• B Cell-depleting biologics, including rituximab, within 6 months.
• Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
• Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
• Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Clinical Research Center of Alabama- Birmingham

Birmingham, Alabama, United States

Investigate MD

Scottsdale, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology

Fountain Valley, California, United States

MD Studies

Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Axon Clinical Research

Inglewood, California, United States

Sunwise Clinical Research

Lafayette, California, United States

Avance Clinical Trials Inc

Laguna Niguel, California, United States

California Allergy and Asthma Medical Group + Research Center

Los Angeles, California, United States

Keck School of Medicine University of Southern California

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

LA Universal Research Center, INC

Los Angeles, California, United States

St. Francis Medical Institute

Clearwater, Florida, United States

GSI Clinical Research, LLC

Margate, Florida, United States

Advanced Medical Research

Sandy Springs, Georgia, United States

Georgia Skin & Cancer Clinic

Savannah, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Sneeze, Wheeze, & Itch Associates LLC

Normal, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Northshore University Healthsystem

Skokie, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

Kansas Medical Clinic, an Elligo Health Research, Inc.

Shawnee Mission, Kansas, United States

Kansas Medical Clinic

Topeka, Kansas, United States

Skin Sciences, PLLC

Louisville, Kentucky, United States

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Tulane Univ School of Med

New Orleans, Louisiana, United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

ActivMed Practices and Research

Beverly, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Crisor, LLC, Medford office

Medford, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

AAPRI Clinical Research Institute

Warwick, Rhode Island, United States

Palmetto Clinical Trial Services, LLC

Anderson, South Carolina, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Rivergate Dermatology Clinical Research Center PL

Goodlettsville, Tennessee, United States

Arlington Research Center, Inc

Arlington, Texas, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Austin Institute for Clinical Research

Dripping Springs, Texas, United States

Innovate Research, LLC

Fort Worth, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Alexandrovska University Hospital

Sofia, , Bulgaria

Euro Derma clinic

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

Medical centre Alitera-Med EOOD

Sofia, , Bulgaria

Dermatology Research Institute

Calgary, Alberta, Canada

CARe Clinic

Red Deer, Alberta, Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

CCA Medical Research

Ajax, Ontario, Canada

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, Canada

Skin Health

Cobourg, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

North York Research Inc.

North York, Ontario, Canada

The Centre for Clinical Trials, Inc

Oakville, Ontario, Canada

Ottawa Allergy Research Corp

Ottawa, Ontario, Canada

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

Skin Health

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

AvantDerm

Toronto, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

International Dermatology Research

Montreal, Quebec, Canada

International Dermatology Research

Montreal, Quebec, Canada

Vahlberg & Pild OU

Talinn, , Estonia

Kliiniliste uuringute Keskus OU

Tartu, , Estonia

Tartu University Hospital

Tartu, , Estonia

CHU de Bordeaux Hop St ANDRE

Bordeaux, Gironde, France

CHRU de Brest - Hôpital Morvan

Brest, , France

CHU Dijonon

Dijon, , France

CHD Vendee

La Roche-sur-Yon, , France

Cabinet Médical

Martigues, , France

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

Nantes, , France

CHU de Nice Hopital de L'Archet

Nice, , France

Hopital Saint Louis

Paris, , France

Hopital Larrey

Toulouse, , France

Studienzentrum Dr.Beate Schwarz

Langenau, Baden-Wurttemberg, Germany

Hautarztpraxis am Löwenmarkt

Stuttgart, Baden-Wurttemberg, Germany

Dermazentrum Augsburg

Augsburg, Bavaria, Germany

Rosenpark Research GmbH

Darmstadt, Hesse, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

Elbe Klinikum Buxtehude

Buxtehude, Lower Saxony, Germany

Klinische Forschung Osnabrück

Osnabrück, Lower Saxony, Germany

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

Company for Medical Study & Service Selters GmbH

Selters, Rhineland-Palatinate, Germany

Hautarztpraxis Dr. Gerlach

Dresden, Saxony, Germany

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

Dresden, Saxony, Germany

Universität Leipzig - Universitätsklinikum

Leipzig, Saxony, Germany

Velocity Clinical Research Leipzig GmbH

Leipzig, Saxony, Germany

SRH Wald-Klinikum Gera

Gera, Thuringia, Germany

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

Augsburg, , Germany

Charité Campus Virchow-Klinikum

Berlin, , Germany

ISA GmbH

Berlin, , Germany

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, , Germany

Dermatologikum Hamburg

Hamburg, , Germany

TFS Trial Support Form GmbH

Hamburg, , Germany

Clinic of Dermatology and STD

Riga, , Latvia

Health and Aesthetics LTD

Riga, , Latvia

Latvian Dermatology Institute

Riga, , Latvia

Health Center 4, Affiliate Diagnostic Center

Riga, , Latvia

Smite Aija - Doctor Practice in Dermatology Venereology

Talsi, , Latvia

JSC "CD8 Alergology Clinic"

Kaunas, , Lithuania

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

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

Vilnius, , Lithuania

Jsc Renmeda

Vilnius, , Lithuania

JSC "Center for Diagnosis and Treatment of Allergic Diseases"

Vilnius, , Lithuania

JSC Inlita (Santaros CTC)

Vilnius, , Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Hospital Infantil de Mexico Federico Gomez

Mexico City, Federal District, Mexico

Grupo Clinico CATEI Sociedad Civil

Guadalajara, Jalisco, Mexico

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, Michoacán, Mexico

Cemdeicy S.C.P.

Mérida, Yucatán, Mexico

Derma Norte del Bajio

Aguascalientes, , Mexico

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

Veracruz, , Mexico

Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

Krakow, Lesser Poland Voivodeship, Poland

Diamond Clinic

Krakow, Lesser Poland Voivodeship, Poland

dermMedica Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, Poland

Centralny Szpital Kliniczny MSWiA

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, Poland

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

Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Labderm s.c.

Ossy, Silesian Voivodeship, Poland

Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

Szczecin, West Pomeranian Voivodeship, Poland

Clinica Vitae Sp. z o.o.

Gdansk, Woj. Pomorskie, Poland

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

Bialystok, , Poland

Wojewodzki Szpital Zespolony

Elblag, , Poland

Oddzial Dermatologii COPERNICUS

Gdansk, , Poland

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

Gdynia, , Poland

Holsamed

Katowice, , Poland

Holsamed

Katowice, , Poland

Gabinet Dermatlogiczny. Beata Krecisz

Kielce, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

Lublin, , Poland

Centrum Alergologii Teresa Hofman

Poznan, , Poland

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

Rzeszów, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

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

Tarnów, , Poland

Clinical Research Group Sp. z o.o.

Warsaw, , Poland

High-Med Prywatny Gabinet Lekarski

Warsaw, , Poland

MTZ Clinical Research Sp.z.o.o.

Warsaw, , Poland

Klinika Ambroziak Sp. Z.O.O.

Warsaw, , Poland

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, , Poland

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

Lodz, Łódź Voivodeship, Poland

National University Hospital

Singapore, Central Singapore, Singapore

Singapore General Hospital

Singapore, , Singapore

Kk Women'S and Childrens Hospital

Singapore, , Singapore

National Skin Centre NSC

Singapore, , Singapore

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Pusan National University Hospital

Busan, Korea, South Korea

Hanyang University Medical Center

Seoul, Korea, South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Incheon St. Mary's Hospital

Incheon, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Hospital Germans Trias i Pujol

Badalona, Catalunya [Cataluña], Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Basurto

Bilbao (Bizkaia), , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Kaohsiung Chang Gung Memorial Hospital

Niaosong, Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, , Taiwan

Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

Poshtova Square 2, Zaporizhzhya, Ukraine

Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

Rivne Regional Dermatology and Venereology Dispensary

Rivne, , Ukraine

Treatment-diagnostic center PE "Asclepius"

Uzhhorod, , Ukraine

Arkansas Research Trials

North Little Rock, Arkansas, United States

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

Orange County Research Institute

Anaheim, California, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Wallace Medical Group, Inc.

Beverly Hills, California, United States

Hope Clinical Research, Inc.

Canoga Park, California, United States

Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Dermatology Clinical Trials

Newport Beach, California, United States

Cura Clinical Research

Palmdale, California, United States

MD Strategies Research Centers MDSRC

Poway, California, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

Integrative Skin Science and Research

Sacramento, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

Therapeutics Clinical Research

San Diego, California, United States

University Clinical Trials

San Diego, California, United States

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

San Diego, California, United States

Synergy Dermatology

San Francisco, California, United States

Care Access Research

San Jose, California, United States

San Luis Dermatology & Laser Clinic

San Luis Obispo, California, United States

Southern California Dermatology, Inc.

Santa Ana, California, United States

IMMUNOe International Research Centers

Centennial, Colorado, United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Central Connecticut Dermatology

Cromwell, Connecticut, United States

Medical Faculty Associates, Inc.

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

George Washington University Medical Center

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

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, United States

Pediatric Skin Research, LLC

Coral Gables, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

The University of Florida Health System

Gainesville, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

The Community Research of South Florida

Hialeah, Florida, United States

Encore Medical Research

Hollywood, Florida, United States

Solutions Through Advanced Research

Jacksonville, Florida, United States

Vitae Research Center, LLC

Miami, Florida, United States

Acevedo Clinical Research Associates

Miami, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

Community Research Foundation Inc

Miami, Florida, United States

Sanchez Clinical Research Inc

Miami, Florida, United States

Miami Dermatology and Laser Research

Miami, Florida, United States

Well Pharma Medical Research Corp.

Miami, Florida, United States

Florida Research Center, Inc

Miami, Florida, United States

C & R Research Services USA

Miami Beach, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Tory Sullivan, MD PA

North Miami Beach, Florida, United States

Park Avenue Dermatology

Orange Park, Florida, United States

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

University of South Florida College of Medicine

Tampa, Florida, United States

Georgia Pollens Clinical Research Centers, Inc

Albany, Georgia, United States

IACT Health - VHC

Columbus, Georgia, United States

Marietta Dermatology Clinical Research

Marietta, Georgia, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

Beacon Clinical Research, LLC

Quincy, Massachusetts, United States

Fivenson Dermatology

Ann Arbor, Michigan, United States

Oakland Dermatology

Auburn Hills, Michigan, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Michigan Center for Research Company

Clarkston, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

St Joseph Dermatology and Vein Clinic

Saint Joseph, Michigan, United States

Associated Skin Care Specialists

Fridley, Minnesota, United States

Associated Skin Care Specialists

New Brighton, Minnesota, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Central Dermatology PC

St Louis, Missouri, United States

Advanced Dermatology of the Midlands

Omaha, Nebraska, United States

ALLCUTIS Research

Portsmouth, New Hampshire, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

Hackensack, New Jersey, United States

Forest Hills Dermatology Group

Kew Gardens, New York, United States

JUVA Skin & Laser Center

New York, New York, United States

Icahn Sch of Med at Mt. Sinai

New York, New York, United States

Sadick Research Group

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Advanced Asthma and Allergy

Watertown, New York, United States

OnSite Clinical Solutions

Charlotte, North Carolina, United States

Medication Management

Greensboro, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Ohio Pediatric Research Association

Dayton, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Central States Research

Tulsa, Oklahoma, United States

OHSU Center for Health and Healing

Portland, Oregon, United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States

Paddington Testing Company Inc

Philadelphia, Pennsylvania, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

DermDox Dermatology Centers

Sugarloaf, Pennsylvania, United States

Peak Research LLC

Upper Saint Clair, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Suzanne Bruce and Associates, PA

Houston, Texas, United States

Encore Imaging & Medical Research

Houston, Texas, United States

Cutis Wellness Dermatology

Laredo, Texas, United States

Laredo Dermatology Associates P.A.

Laredo, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Acclaim Dermatology PLLC

Sugar Land, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

University of Utah MidValley Dematology

Murray, Utah, United States

Velocity Clinical Research - Woseth Dermatology

Salt Lake City, Utah, United States

Jordan Valley Dermatology Center

West Jordan, Utah, United States

PI-Coor Clinical Research, LLC

Burke, Virginia, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dermatology Associates of Seattle

Seattle, Washington, United States

Premier Clinical Research

Spokane, Washington, United States

Woden Dermatology

Phillip, Australian Capital Territory, Australia

The Skin Hospital

Darlinghurst, New South Wales, Australia

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

The St. George Hospital

Kogarah, New South Wales, Australia

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Skin & Cancer Foundation Australia

Westmead, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

University of the Sunshine Coast Clinical Trial Centre

Sippy Downs, Queensland, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Clinical Trials SA Pty Ltd

Hectorville, South Australia, Australia

Emeritus Research

Camberwell, Victoria, Australia

Skin Health Institute Inc.

Carlton, Victoria, Australia

Sinclair Dermatology

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

Burswood Dermatology

Victoria Park, Western Australia, Australia

Captain Stirling Medical Centre

Nedlands, , Australia

DCC Sveti Georgi

Haskovo, , Bulgaria

Diagnostic and Consultation Center 14

Sofia, , Bulgaria

Countries

Canada; Estonia; France; Germany; Latvia; Lithuania; Mexico; Poland; Singapore; South Korea; Spain; Taiwan; Ukraine; United States; Australia; Bulgaria

References

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.

Reference Type: DERIVED

PMID: 40549127 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Study Protocol

View Document

Document Type: Study Protocol: Study Protocol Addendum

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-001211-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

J2T-DM-KGAA

Identifier Type: OTHER

Identifier Source: secondary_id

DRM06-AD07

Identifier Type: OTHER

Identifier Source: secondary_id

17789

Identifier Type: -

Identifier Source: org_study_id