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

A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: Lebrikizumab

Detailed Description

Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06- AD18, 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.

• Study Type: Interventional
• Enrollment (Actual): 1188
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia, 6009
    • Captain Stirling Medical Centre
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 02010
      • The Skin Hospital
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists Pty Ltd
    • Kogarah, New South Wales, Australia, 2217
      • The St. George Hospital
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
    • Westmead, New South Wales, Australia, 2045
      • Skin & Cancer Foundation Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Sippy Downs, Queensland, Australia, 04556
      • University of the Sunshine Coast Clinical Trial Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • South Australia
    • Hectorville, South Australia, Australia, 5073
      • Clinical Trials SA Pty Ltd
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc.
    • Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital
    • Parkville, Victoria, Australia, 03050
      • The Royal Melbourne Hospital
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
    • Victoria Park, Western Australia, Australia, 06100
      • Burswood Dermatology
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • DCC Sveti Georgi
  • Sofia, Bulgaria, 1606
    • Military Medical Academy
  • Sofia, Bulgaria, 1431
    • Alexandrovska University Hospital
  • Sofia, Bulgaria, 1408
    • Diagnostic and Consultation Center 14
  • Sofia, Bulgaria, 1606
    • Euro Derma clinic
  • Sofia, Bulgaria, 1618
    • Medical centre Alitera-Med EOOD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute
    • Red Deer, Alberta, Canada, T4P1K4
      • Care Clinic
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-Ho Hong Medical Inc.
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • University of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Ajax, Ontario, Canada, L1S7K8
      • CCA Medical Research
    • Barrie, Ontario, Canada, L4M 7G1
      • Simcoderm Medical & Surgical Dermatology Centre
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Skin Health
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • North York, Ontario, Canada, M2M4J5
      • North York Research Inc.
    • Oakville, Ontario, Canada, L6J7W5
      • The Centre for Clinical Trials, Inc
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corp
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M5A3R6
      • AvantDerm
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Montreal, Quebec, Canada, H3H1V4
      • International Dermatology Research
• Estonia
  • Talinn, Estonia, 10134
    • Vahlberg & Pild OU
  • Tartu, Estonia, 50160
    • Kliiniliste uuringute Keskus OU
  • Tartu, Estonia, 51417
    • Tartu University Hospital
• France
  • Brest, France, 29200
    • CHRU de Brest - Hôpital Morvan
  • Dijon, France, 21079
    • CHU Dijonon
  • La Roche sur Yon, France, 85000
    • CHD Vendee
  • Martigues, France, 13500
    • Cabinet Médical
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Nice, France, 06202
    • Chu de Nice Hopital de L'Archet
  • Paris, France, 75010
    • Hopital Saint Louis
  • Toulouse cedex 9, France, 31059
    • Hopital Larrey
  • Gironde
    • Bordeaux, Gironde, France, 33075
      • CHU de Bordeaux Hop St ANDRE
• Germany
  • Augsburg, Germany, 86150
    • Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
  • Berlin, Germany, 10789
    • ISA GmbH
  • Berlin, Germany, 10117
    • Charité Campus Virchow-Klinikum
  • Berlin, Germany, 13055
    • Praxis für Ganzheitliche Dermatologie im Ärztehaus
  • Hamburg, Germany, 20144
    • Dermatologikum Hamburg
  • Hamburg, Germany, 20537
    • TFS Trial Support Form GmbH
  • Baden-Württemberg
    • Langenau, Baden-Württemberg, Germany, 89129
      • Studienzentrum Dr.Beate Schwarz
    • Stuttgart, Baden-Württemberg, Germany, 70499
      • Hautarztpraxis am Löwenmarkt
  • Bayern
    • Augsburg, Bayern, Germany, 86179
      • Dermazentrum Augsburg
  • Hesse
    • Frankfurt, Hesse, Germany, 60590
      • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Rosenpark Research GmbH
    • Frankfurt am Main, Hessen, Germany, 60596
      • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Lower Saxony
    • Osnabrück, Lower Saxony, Germany, 49074
      • Klinische Forschung Osnabrück
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Fachklinik Bad Bentheim
    • Buxtehude, Niedersachsen, Germany, 21614
      • Elbe Klinikum Buxtehude
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44793
      • Hautzentrum im Jahrhunderthaus
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitätsklinikum Münster - Albert Schweitzer Campus
  • Rheinland-Pfalz
    • Selters, Rheinland-Pfalz, Germany, 56242
      • Company For Medical Study & Service Selters Gmbh
  • Sachsen
    • Dresden, Sachsen, Germany, 01097
      • Hautarztpraxis Dr. Gerlach
    • Leipzig, Sachsen, Germany, 04103
      • Universität Leipzig - Universitätsklinikum
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
    • Leipzig, Saxony, Germany, 04103
      • Velocity Clinical Research Leipzig GmBH
  • Thüringen
    • Gera, Thüringen, Germany, 07548
      • SRH Wald-Klinikum Gera
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Incheon, Korea, Republic of, 21431
    • Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 06973
    • Chung-ang University Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
      • Soon Chun Hyang University Bucheon Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Korea
    • Busan, Korea, Korea, Republic of, 49241
      • Pusan National University Hospital
    • Seoul, Korea, Korea, Republic of, 04763
      • Hanyang University Medical Center
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 07441
      • Hallym University Kangnam Sacred Heart Hospital
• Latvia
  • Riga, Latvia, LV-1001
    • Clinic of Dermatology and STD
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Riga, Latvia, LV-1011
    • Latvian Dermatology Institute
  • Riga, Latvia, LV1003
    • Health Center 4, Affiliate Diagnostic Center
  • Talsi, Latvia, LV-3201
    • Smite Aija - Doctor Practice in Dermatology Venereology
• Lithuania
  • Kaunas, Lithuania, LT-44192
    • JSC "CD8 Alergology Clinic"
  • Kaunas, Lithuania, LT-50161
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Vilnius, Lithuania, LT-07195
    • Jsc Renmeda
  • Vilnius, Lithuania, LT-08109
    • JSC "Center for Diagnosis and Treatment of Allergic Diseases"
  • Vilnius, Lithuania, LT-08406
    • JSC Inlita (Santaros CTC)
  • Vilnius, Lithuania, LT-08441
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania, 08406
    • Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
• Mexico
  • Aguascalientes, Mexico, 20130
    • Derma Norte del Bajío
  • Veracruz, Mexico, 91910
    • ARKE Estudios Clínicos S.A. de C.V.
  • Federal District
    • Ciudad de Mexico, Federal District, Mexico, 06720
      • Hospital Infantil de Mexico Federico Gomez
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44657
      • Grupo Clinico CATEI Sociedad Civil
  • Michoacan
    • Morelia, Michoacan, Mexico, 58249
      • Clinica De Enfermedades Cronicas y Procedimientos Especiales
  • Yucatán
    • Merida, Yucatán, Mexico, 97130
      • Cemdeicy S.C.P.
• Poland
  • Bialystok, Poland, 15-369
    • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony
  • Gdansk, Poland, 80-462
    • Oddzial Dermatologii COPERNICUS
  • Gdynia, Poland, 81-553
    • Centrum Badan Klinicznych Pi-House Sp. Z O.O.
  • Katowice, Poland, 40-600
    • Holsamed
  • Kielce, Poland, 25-155
    • Gabinet Dermatlogiczny. Beata Krecisz
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
  • Poznan, Poland, 60-214
    • Centrum Alergologii Teresa Hofman
  • Rzeszow, Poland, 35-055
    • Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
  • Szczecin, Poland, 71 500
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Tarnow, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
  • Warszawa, Poland, 01-142
    • Clinical Research Group Sp. z o.o.
  • Warszawa, Poland, 01-817
    • High-Med Prywatny Gabinet Lekarski
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp.z.o.o.
  • Warszawa, Poland, 02-953
    • Klinika Ambroziak Sp. Z.O.O.
  • Wroclaw, Poland, 50-566
    • CityClinic Przychodnia Lekarsko-Psychologiczna
  • Dolnośląskie
    • Wrocław, Dolnośląskie, Poland, 51-503
      • Dermmedica Sp. Z O.O.
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-033
      • Grazyna Pulka Specjalistyczny Osrodek "All-Med"
    • Krakow, Malopolskie, Poland, 31-559
      • Diamond Clinic
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-625
      • Centrum Medyczne Evimed
    • Warszawa, Mazowieckie, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA
  • Slaskie
    • Ossy, Slaskie, Poland, 42-624
      • Labderm s.c.
  • Woj. Pomorskie
    • Gdansk, Woj. Pomorskie, Poland, 80-344
      • Clinica Vitae Sp. z o.o.
  • Wojewodztwo Podkarpackie
    • Iwonicz Zdroj, Wojewodztwo Podkarpackie, Poland, 38-440
      • Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-332
      • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
  • Śląskie
    • Katowice, Śląskie, Poland, 40-611
      • Centrum Medyczne Angelius Provita
• Singapore
  • Singapore, Singapore, 169078
    • Singapore General Hospital
  • Singapore, Singapore, 229899
    • Kk Women'S and Childrens Hospital
  • Singapore, Singapore, 308205
    • National Skin Centre NSC
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 119074
      • National University Hospital
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Bilbao (Bizkaia), Spain, 48013
    • Hospital Universitario Basurto
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor-INTERNAL MED
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Barcelona [Barcelona]
    • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 8950
      • Hospital Sant Joan de Deu
  • Catalunya [Cataluña]
    • Badalona, Catalunya [Cataluña], Spain, 08916
      • Hospital Germans Trias i Pujol
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital - Linkou
  • Kaohsiung City
    • Niaosong, Kaohsiung City, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital
• Ukraine
  • Kharkiv, Ukraine, 61038
    • Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
  • Kharkiv, Ukraine, 61057
    • SE "Institute of Dermatology and Venerology of NAMS of Ukraine"
  • Rivne, Ukraine, 33028
    • Rivne Regional Dermatology and Venereology Dispensary
  • Uzhhorod, Ukraine, 88000
    • Treatment-diagnostic center PE "Asclepius"
  • Zaporizhzhya
    • Poshtova Square 2, Zaporizhzhya, Ukraine, 69063
      • Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
    • Birmingham, Alabama, United States, 35244
      • Clinical Research Center of Alabama- Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Bakersfield, California, United States, 93309
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc.
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fountain Valley, California, United States, 92708
      • MD Studies
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Avance Trials
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group + Research Center
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine University of Southern California
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, INC
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute and Research Center
    • Newport Beach, California, United States, 92660
      • Dermatology Clinical Trials
    • Palmdale, California, United States, 93551
      • Cura Clinical Research
    • Poway, California, United States, 92064
      • MD Strategies Research Centers MDSRC
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • Sacramento, California, United States, 95825
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • San Diego, California, United States, 92123
      • University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
    • San Francisco, California, United States, 94132
      • Synergy Dermatology
    • San Jose, California, United States, 95117
      • Care Access Research
    • San Luis Obispo, California, United States, 93405
      • San Luis Dermatology & Laser Clinic
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe International Research Centers
    • Colorado Springs, Colorado, United States, 80907-6231
      • Asthma and Allergy Associates, PC
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Central Connecticut Dermatology
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
    • Washington, District of Columbia, United States, 20016
      • Medical Faculty Associates, Inc.
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC
    • Coral Gables, Florida, United States, 33146
      • Pediatric Skin Research, LLC
    • Fort Myers, Florida, United States, 33912
      • Clinical Physiology Associates
    • Gainesville, Florida, United States, 32606
      • The University of Florida Health System
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hialeah, Florida, United States, 33016
      • The Community Research of South Florida
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research
    • Margate, Florida, United States, 33063
      • GSI Clinical Research, LLC
    • Miami, Florida, United States, 33142
      • Acevedo Clinical Research Associates
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Miami, Florida, United States, 33135
      • Vitae Research Center, LLC
    • Miami, Florida, United States, 33145
      • Community Research Foundation Inc
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research Inc
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research Corp.
    • Miami, Florida, United States, 33174
      • Florida Research Center, Inc
    • Miami Beach, Florida, United States, 33169
      • C & R Research Services USA
    • Miami Lakes, Florida, United States, 33016
      • Wellness Clinical Research
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, Md Pa
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Pembroke Pines, Florida, United States, 33028
      • Riverchase Dermatology and Cosmetic Surgery
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33613-1244
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33620
      • University of South Florida College of Medicine
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers, Inc
    • Columbus, Georgia, United States, 31904
      • IACT Health - VHC
    • Marietta, Georgia, United States, 30060
      • Marietta Dermatology Clinical Research
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research
    • Savannah, Georgia, United States, 31419
      • Georgia Skin & Cancer Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates LLC
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
    • Shawnee Mission, Kansas, United States, 66216
      • Kansas Medical Clinic, an Elligo Health Research, Inc.
    • Topeka, Kansas, United States, 66614
      • Kansas Medical Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research
    • New Orleans, Louisiana, United States, 70112
      • Tulane Univ School of Med
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists, LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ActivMed Practices and Research
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Fivenson Dermatology
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Dermatology
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Clarkston, Michigan, United States, 48346
      • Michigan Center for Research Company
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Saint Joseph, Michigan, United States, 49085
      • St Joseph Dermatology and Vein Clinic
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Associated Skin Care Specialists
    • New Brighton, Minnesota, United States, 55112
      • Associated Skin Care Specialists
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology PC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Advanced Dermatology of the Midlands
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Jdr Dermatology Research
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ALLCUTIS Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
  • New York
    • Bronx, New York, United States, 10467-2490
      • Montefiore Medical Center
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10022-3350
      • Juva Skin & Laser Center
    • New York, New York, United States, 10029
      • Icahn Sch of Med at Mt. Sinai
    • Watertown, New York, United States, 13601
      • Advanced Asthma and Allergy
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Onsite Clinical Solutions
    • Greensboro, North Carolina, United States, 27408
      • Medication Management
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Crisor, LLC, Medford office
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97239
      • OHSU Center for Health and Healing
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • The Pennsylvania Centre for Dermatology, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Sugarloaf, Pennsylvania, United States, 18249
      • DermDox Dermatology Centers
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Peak Research LLC
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
    • Warwick, Rhode Island, United States, 02886
      • AAPRI Clinical Research Institute
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Palmetto Clinical Trial Services, LLC
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Clinical Research Center PL
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Dripping Springs, Texas, United States, 78620
      • Austin Institute for Clinical Research
    • Fort Worth, Texas, United States, 76244
      • Innovate Research, LLC
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • Houston, Texas, United States, 77065
      • Encore Imaging & Medical Research
    • Laredo, Texas, United States, 78041
      • Cutis Wellness Dermatology
    • Laredo, Texas, United States, 78041
      • Laredo Dermatology Associates P.A.
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Acclaim Dermatology PLLC
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah MidValley Dematology
    • Salt Lake City, Utah, United States, 84117
      • Velocity Clinical Research - Woseth Dermatology
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research, LLC
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for participants coming from a parent study:

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.

Exclusion Criteria for participants coming from a parent study:

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.

Open-Label Addendum Inclusion Criteria:

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.

Open-Label Addendum Exclusion Criteria:

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.

Open-Label Extension Addendum Inclusion Criteria:

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

Open-Label Extension Addendum Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab Q2W (Open-Label) from Parent Study; Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q2W (Blinded) from Parent Study; Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q2W (Open-Label Addendum); Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q4W; Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection. Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q4W (Open-Label Extension Addendum); Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q8W (Open-Label Extension Addendum); Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06
Experimental: Lebrikizumab Q2W (Open-Label Extension Addendum); Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.	Biological: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; DRM06

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit	Baseline to Week 100

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1	Baseline to Week 100
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study	Baseline to Week 100

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Dermira, Inc.
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): April 16, 2025

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Eczema; Dermatitis, Atopic; Skin Diseases; Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 17789; 2020-001211-24 (EudraCT Number); J2T-DM-KGAA (Other Identifier: Eli Lilly and Company); DRM06-AD07 (Other Identifier: Dermira, Inc. (A wholly owned subsidiary of Lilly))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No