Back to resultsLong-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) (ADjoin)
Primary Purpose
Atopic Dermatitis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases
Eligibility Criteria
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, 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.
Sites / Locations
- Pinnacle Research Group, LLC
- Clinical Research Center of Alabama- Birmingham
- Investigate MD
- Johnson Dermatology
- Burke Pharmaceutical Research
- Arkansas Research Trials
- Northwest Arkansas Clinical Trials Center
- Orange County Research Institute
- Bakersfield Dermatology and Skin Cancer Medical Group
- Wallace Medical Group, Inc.
- Hope Clinical Research, Inc.
- California Dermatology & Clinical Research Institute
- First OC Dermatology
- MD Studies
- Center For Dermatology Clinical Research, Inc.
- Axon Clinical Research
- Sunwise Clinical Research
- Avance Trials
- California Allergy and Asthma Medical Group + Research Center
- Keck School of Medicine University of Southern California
- Dermatology Research Associates
- LA Universal Research Center, INC
- Ablon Skin Institute and Research Center
- Dermatology Clinical Trials
- Cura Clinical Research
- Integrative Skin Science and Research
- Integrative Skin Science and Research
- Therapeutics Clinical Research
- University Clinical Trials
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
- Synergy Dermatology
- Care Access Research
- San Luis Dermatology & Laser Clinic
- Southern California Dermatology, Inc.
- IMMUNOe International Research Centers
- Asthma and Allergy Associates, PC
- Central Connecticut Dermatology
- Medical Faculty Associates, Inc.
- George Washington University Medical Center
- St. Francis Medical Institute
- Florida Academic Centers Research and Education, LLC
- Pediatric Skin Research, LLC
- Clinical Physiology Associates
- The University of Florida Health System
- Direct Helpers Research Center
- The Community Research of South Florida
- Encore Medical Research
- Solutions Through Advanced Research
- GSI Clinical Research, LLC
- C & R Research Services USA
- Wellness Clinical Research
- Vitae Research Center, LLC
- Acevedo Clinical Research Associates
- International Dermatology Research, Inc.
- Community Research Foundation Inc
- Sanchez Clinical Research Inc
- Miami Dermatology and Laser Research
- Well Pharma Medical Research Corp.
- Florida Research Center, Inc
- Tory Sullivan, MD PA
- Park Avenue Dermatology
- Riverchase Dermatology and Cosmetic Surgery
- ForCare Clinical Research
- University of South Florida College of Medicine
- Georgia Pollens Clinical Research Centers, Inc
- IACT Health - VHC
- Marietta Dermatology Clinical Research
- Advanced Medical Research
- Georgia Skin & Cancer Clinic
- Northwestern University
- Sneeze, Wheeze, & Itch Associates LLC
- Arlington Dermatology
- Dundee Dermatology
- Dawes Fretzin Clinical Research Group, LLC
- The Indiana Clinical Trials Center
- Epiphany Dermatology of Kansas, LLC
- Kansas Medical Clinic, an Elligo Health Research, Inc.
- Kansas Medical Clinic
- Skin Sciences, PLLC
- Meridian Clinical Research
- Tulane Univ School of Med
- Dermatology and Skin Cancer Specialists, LLC
- ActivMed Practices and Research
- Tufts Medical Center
- Brigham and Women's Hospital
- Metro Boston Clinical Partners
- Beacon Clinical Research, LLC
- Fivenson Dermatology
- Oakland Dermatology
- Great Lakes Research Group, Inc.
- Michigan Center for Research Company
- Henry Ford Hospital
- St Joseph Dermatology and Vein Clinic
- Associated Skin Care Specialists
- MediSearch Clinical Trials
- Central Dermatology PC
- Advanced Dermatology of the Midlands
- JDR Dermatology Research
- ALLCUTIS Research
- Psoriasis Treatment Center of Central New Jersey
- Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
- Forest Hills Dermatology Group
- JUVA Skin & Laser Center
- Icahn Sch of Med at Mt. Sinai
- Sadick Research Group
- Advanced Asthma and Allergy
- OnSite Clinical Solutions
- Medication Management
- Wake Research Associates
- Wilmington Dermatology Center
- University Hospitals Case Medical Center
- Ohio Pediatric Research Association
- Lynn Health Science Institute
- Unity Clinical Research
- Central States Research
- Vital Prospects Clinical Research Institute, PC
- Crisor, LLC, Medford office
- Oregon Dermatology and Research Center
- Oregon Medical Research Center
- OHSU Center for Health and Healing
- The Pennsylvania Centre for Dermatology, LLC
- Paddington Testing Company Inc
- University of Pennsylvania Hospital
- DermDox Dermatology Centers
- Peak Research LLC
- Clinical Partners, LLC
- AAPRI Clinical Research Institute
- Palmetto Clinical Trial Services, LLC
- Clinical Research Center of the Carolinas
- Medical University of South Carolina
- Rivergate Dermatology Clinical Research Center PL
- Arlington Research Center, Inc
- Bellaire Dermatology Associates
- Dermatology Treatment and Research Center
- Modern Research Associates
- Austin Institute for Clinical Research
- Innovate Research, LLC
- Center for Clinical Studies
- Suzanne Bruce and Associates, PA
- Encore Imaging & Medical Research
- Cutis Wellness Dermatology
- Laredo Dermatology Associates P.A.
- Austin Institute for Clinical Research
- Progressive Clinical Research
- Texas Dermatology and Laser Specialists
- Acclaim Dermatology PLLC
- Center for Clinical Studies
- University of Utah MidValley Dematology
- Velocity Clinical Research - Woseth Dermatology
- Jordan Valley Dermatology Center
- PI-Coor Clinical Research, LLC
- Virginia Clinical Research, Inc.
- Dermatology Associates of Seattle
- Premier Clinical Research
- Woden Dermatology
- The Skin Hospital
- Premier Specialists Pty Ltd
- The St. George Hospital
- Holdsworth House Medical Practice
- Skin & Cancer Foundation Australia
- Westmead Hospital
- The Skin Centre
- University of the Sunshine Coast Clinical Trial Centre
- Veracity Clinical Research Pty Ltd
- Clinical Trials SA Pty Ltd
- Emeritus Research
- Skin Health Institute Inc.
- Sinclair Dermatology
- The Royal Melbourne Hospital
- Royal Children's Hospital
- Fremantle Dermatology
- Burswood Dermatology
- Captain Stirling Medical Centre
- DCC Sveti Georgi
- Diagnostic and Consultation Center 14
- Alexandrovska University Hospital
- Euro Derma clinic
- Military Medical Academy
- Medical centre Alitera-Med EOOD
- Dermatology Research Institute
- CARe Clinic
- Dr. Chih-ho Hong Medical Inc.
- Enverus Medical Research
- University of British Columbia
- Wiseman Dermatology Research Inc.
- CCA Medical Research
- Simcoderm Medical & Surgical Dermatology Centre
- Skin Health
- Lynderm Research Inc.
- North York Research Inc.
- The Centre for Clinical Trials, Inc
- Ottawa Allergy Research Corp
- Dermatology Ottawa Research Centre
- The Centre for Dermatology
- AvantDerm
- K. Papp Clinical Research
- International Dermatology Research
- Vahlberg & Pild OU
- Kliiniliste uuringute Keskus OU
- Tartu University Hospital
- CHU de Bordeaux Hop St ANDRE
- CHRU de Brest - Hôpital Morvan
- CHU Dijonon
- CHD Vendee
- Cabinet Médical
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
- CHU de Nice Hopital de L'Archet
- Hopital Saint Louis
- Hopital Larrey
- Studienzentrum Dr.Beate Schwarz
- Hautarztpraxis am Löwenmarkt
- Dermazentrum Augsburg
- Rosenpark Research GmbH
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
- Klinische Forschung Osnabrück
- Fachklinik Bad Bentheim
- Elbe Klinikum Buxtehude
- Hautzentrum im Jahrhunderthaus
- Company for Medical Study & Service Selters GmbH
- Hautarztpraxis Dr. Gerlach
- Universität Leipzig - Universitätsklinikum
- Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
- Velocity Clinical Research Leipzig GmbH
- SRH Wald-Klinikum Gera
- Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
- Charité Campus Virchow-Klinikum
- ISA GmbH
- Praxis für Ganzheitliche Dermatologie im Ärztehaus
- Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
- Dermatologikum Hamburg
- TFS Trial Support Form GmbH
- Soon Chun Hyang University Bucheon Hospital
- Ajou University Hospital
- Pusan National University Hospital
- Hanyang University Medical Center
- Asan Medical Center
- Korea University Ansan Hospital
- Incheon St. Mary's Hospital
- Severance Hospital, Yonsei University Health System
- Konkuk University Medical Center
- Clinic of Dermatology and STD
- Health and Aesthetics LTD
- Latvian Dermatology Institute
- Health Center 4, Affiliate Diagnostic Center
- Smite Aija - Doctor Practice in Dermatology Venereology
- JSC "CD8 Alergology Clinic"
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
- Jsc Renmeda
- JSC "Center for Diagnosis and Treatment of Allergic Diseases"
- JSC Inlita (Santaros CTC)
- Vilnius University Hospital Santaros Klinikos
- Hospital Infantil de Mexico Federico Gomez
- Grupo Clinico CATEI Sociedad Civil
- Clinica De Enfermedades Cronicas y Procedimientos Especiales
- Cemdeicy S.C.P.
- Derma Norte del Bajio
- Arke Estudios Clinicos S.A. de C.V.
- dermMedica Sp. z o.o.
- Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
- Diamond Clinic
- Centrum Medyczne Evimed
- Centralny Szpital Kliniczny MSWiA
- Labderm s.c.
- Clinica Vitae Sp. z o.o.
- Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
- Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
- Wojewodzki Szpital Zespolony
- Oddzial Dermatologii COPERNICUS
- Holsamed
- Gabinet Dermatlogiczny. Beata Krecisz
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
- Centrum Alergologii Teresa Hofman
- Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
- Clinical Research Group Sp. z o.o.
- High-Med Prywatny Gabinet Lekarski
- MTZ Clinical Research Sp.z.o.o.
- Klinika Ambroziak Sp. Z.O.O.
- CityClinic Przychodnia Lekarsko-Psychologiczna
- Centrum Medyczne Angelius Provita
- National University Hospital
- Singapore General Hospital
- Kk Women'S and Childrens Hospital
- National Skin Centre NSC
- Hospital Sant Joan de Déu
- Hospital Germans Trias i Pujol
- Hospital General Universitario de Alicante
- Hospital Clinic de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Basurto
- Hospital Universitario Infanta Leonor-INTERNAL MED
- Hospital Universitario Virgen Macarena
- Kaohsiung Chang Gung Memorial Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taipei Medical University Shuang Ho Hospital
- Chung Shan Medical University Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
- Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
- SE "Institute of Dermatology and Venerology of NAMS of Ukraine"
- Rivne Regional Dermatology and Venereology Dispensary
- Treatment-diagnostic center PE "Asclepius"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Lebrikizumab Q2W (Open-Label) from Parent Study
Lebrikizumab Q2W (Blinded) from Parent Study
Lebrikizumab Q2W (Open-Label Addendum)
Lebrikizumab Q4W
Arm Description
Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.
Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.
Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit
Secondary Outcome Measures
Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study
Full Information
NCT ID
NCT04392154
First Posted
May 13, 2020
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
Collaborators
Dermira, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04392154
Brief Title
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Acronym
ADjoin
Official Title
A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Dermira, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This 110-week study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lebrikizumab Q2W (Open-Label) from Parent Study
Arm Type
Experimental
Arm Description
Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.
Arm Title
Lebrikizumab Q2W (Blinded) from Parent Study
Arm Type
Experimental
Arm Description
Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.
Arm Title
Lebrikizumab Q2W (Open-Label Addendum)
Arm Type
Experimental
Arm Description
Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.
Arm Title
Lebrikizumab Q4W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
LY3650150, DRM06
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit
Time Frame
Baseline to Week 100
Secondary Outcome Measure Information:
Title
Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1
Time Frame
Baseline to Week 100
Title
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study
Time Frame
Baseline to Week 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Clinical Research Center of Alabama- Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Investigate MD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Bakersfield Dermatology and Skin Cancer Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Wallace Medical Group, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
MD Studies
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Center For Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Axon Clinical Research
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Avance Trials
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
California Allergy and Asthma Medical Group + Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Keck School of Medicine University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
LA Universal Research Center, INC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Ablon Skin Institute and Research Center
City
Manhattan Beach
State/Province
California
ZIP/Postal Code
90266
Country
United States
Facility Name
Dermatology Clinical Trials
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Cura Clinical Research
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Synergy Dermatology
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Facility Name
Care Access Research
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
San Luis Dermatology & Laser Clinic
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma and Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907-6231
Country
United States
Facility Name
Central Connecticut Dermatology
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Medical Faculty Associates, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Pediatric Skin Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
The University of Florida Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
The Community Research of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Encore Medical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Solutions Through Advanced Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
GSI Clinical Research, LLC
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
C & R Research Services USA
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Wellness Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Vitae Research Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Community Research Foundation Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Sanchez Clinical Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Well Pharma Medical Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Florida Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Riverchase Dermatology and Cosmetic Surgery
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers, Inc
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
IACT Health - VHC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Marietta Dermatology Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advanced Medical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Georgia Skin & Cancer Clinic
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Epiphany Dermatology of Kansas, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Kansas Medical Clinic, an Elligo Health Research, Inc.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Meridian Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Tulane Univ School of Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ActivMed Practices and Research
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Fivenson Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Oakland Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Michigan Center for Research Company
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St Joseph Dermatology and Vein Clinic
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Associated Skin Care Specialists
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Central Dermatology PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Advanced Dermatology of the Midlands
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
JDR Dermatology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
ALLCUTIS Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
JUVA Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022-3350
Country
United States
Facility Name
Icahn Sch of Med at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Advanced Asthma and Allergy
City
Watertown
State/Province
New York
ZIP/Postal Code
13601
Country
United States
Facility Name
OnSite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Medication Management
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Central States Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Crisor, LLC, Medford office
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
OHSU Center for Health and Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Pennsylvania Centre for Dermatology, LLC
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Paddington Testing Company Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
DermDox Dermatology Centers
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Facility Name
Peak Research LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
AAPRI Clinical Research Institute
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Rivergate Dermatology Clinical Research Center PL
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Arlington Research Center, Inc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Dripping Springs
State/Province
Texas
ZIP/Postal Code
78620
Country
United States
Facility Name
Innovate Research, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Encore Imaging & Medical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Cutis Wellness Dermatology
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Laredo Dermatology Associates P.A.
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Acclaim Dermatology PLLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Utah MidValley Dematology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Velocity Clinical Research - Woseth Dermatology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
The Skin Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
02010
Country
Australia
Facility Name
Premier Specialists Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Skin & Cancer Foundation Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2045
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
University of the Sunshine Coast Clinical Trial Centre
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
04556
Country
Australia
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Clinical Trials SA Pty Ltd
City
Hectorville
State/Province
South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Skin Health Institute Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
03050
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
06100
Country
Australia
Facility Name
Captain Stirling Medical Centre
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
DCC Sveti Georgi
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Diagnostic and Consultation Center 14
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Alexandrovska University Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Euro Derma clinic
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Medical centre Alitera-Med EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P1K4
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S7K8
Country
Canada
Facility Name
Simcoderm Medical & Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Skin Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
North York Research Inc.
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M4J5
Country
Canada
Facility Name
The Centre for Clinical Trials, Inc
City
Oakville Ontario
State/Province
Ontario
ZIP/Postal Code
L6J7W5
Country
Canada
Facility Name
Ottawa Allergy Research Corp
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
AvantDerm
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A3R6
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
International Dermatology Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H1V4
Country
Canada
Facility Name
Vahlberg & Pild OU
City
Talinn
ZIP/Postal Code
10134
Country
Estonia
Facility Name
Kliiniliste uuringute Keskus OU
City
Tartu
ZIP/Postal Code
50160
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51417
Country
Estonia
Facility Name
CHU de Bordeaux Hop St ANDRE
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Dijonon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHD Vendee
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Cabinet Médical
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice Hopital de L'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Larrey
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Studienzentrum Dr.Beate Schwarz
City
Langenau
State/Province
Baden-Württemberg
ZIP/Postal Code
89129
Country
Germany
Facility Name
Hautarztpraxis am Löwenmarkt
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70499
Country
Germany
Facility Name
Dermazentrum Augsburg
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Facility Name
Rosenpark Research GmbH
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinische Forschung Osnabrück
City
Osnabrueck
State/Province
Lower Saxony
ZIP/Postal Code
49074
Country
Germany
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
Hautzentrum im Jahrhunderthaus
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44793
Country
Germany
Facility Name
Company for Medical Study & Service Selters GmbH
City
Selters
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56242
Country
Germany
Facility Name
Hautarztpraxis Dr. Gerlach
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
Country
Germany
Facility Name
Universität Leipzig - Universitätsklinikum
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Velocity Clinical Research Leipzig GmbH
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
SRH Wald-Klinikum Gera
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
ISA GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Praxis für Ganzheitliche Dermatologie im Ärztehaus
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Dermatologikum Hamburg
City
Hamburg
ZIP/Postal Code
20144
Country
Germany
Facility Name
TFS Trial Support Form GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Soon Chun Hyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Clinic of Dermatology and STD
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Health and Aesthetics LTD
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Facility Name
Latvian Dermatology Institute
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Health Center 4, Affiliate Diagnostic Center
City
Riga
ZIP/Postal Code
LV1003
Country
Latvia
Facility Name
Smite Aija - Doctor Practice in Dermatology Venereology
City
Talsi
ZIP/Postal Code
LV-3201
Country
Latvia
Facility Name
JSC "CD8 Alergology Clinic"
City
Kaunas
ZIP/Postal Code
LT-44192
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Jsc Renmeda
City
Vilnius
ZIP/Postal Code
LT-07195
Country
Lithuania
Facility Name
JSC "Center for Diagnosis and Treatment of Allergic Diseases"
City
Vilnius
ZIP/Postal Code
LT-08109
Country
Lithuania
Facility Name
JSC Inlita (Santaros CTC)
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08441
Country
Lithuania
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Ciudad de Mexico
State/Province
Federal District
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Grupo Clinico CATEI Sociedad Civil
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44657
Country
Mexico
Facility Name
Clinica De Enfermedades Cronicas y Procedimientos Especiales
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Facility Name
Cemdeicy S.C.P.
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Derma Norte del Bajio
City
Aguascalientes
ZIP/Postal Code
20130
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
dermMedica Sp. z o.o.
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-503
Country
Poland
Facility Name
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Diamond Clinic
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Labderm s.c.
City
Ossy
State/Province
Slaskie
ZIP/Postal Code
42-624
Country
Poland
Facility Name
Clinica Vitae Sp. z o.o.
City
Gdansk
State/Province
Woj. Pomorskie
ZIP/Postal Code
80-344
Country
Poland
Facility Name
Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
City
Iwonicz Zdroj
State/Province
Wojewodztwo Podkarpackie
ZIP/Postal Code
38-440
Country
Poland
Facility Name
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
City
Bialystok
ZIP/Postal Code
15-369
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Oddzial Dermatologii COPERNICUS
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Holsamed
City
Katowice
ZIP/Postal Code
40-600
Country
Poland
Facility Name
Gabinet Dermatlogiczny. Beata Krecisz
City
Kielce
ZIP/Postal Code
25-155
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71 500
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Clinical Research Group Sp. z o.o.
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Facility Name
High-Med Prywatny Gabinet Lekarski
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
MTZ Clinical Research Sp.z.o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Klinika Ambroziak Sp. Z.O.O.
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Facility Name
CityClinic Przychodnia Lekarsko-Psychologiczna
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-611
Country
Poland
Facility Name
National University Hospital
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169078
Country
Singapore
Facility Name
Kk Women'S and Childrens Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
National Skin Centre NSC
City
Singapore
ZIP/Postal Code
308205
Country
Singapore
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8950
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Basurto
City
Bilbao (Bizkaia)
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor-INTERNAL MED
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Niaosong Dist
State/Province
Kaohsiung City
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
City
Poshtova Str. 2
State/Province
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
City
Kharkiv
ZIP/Postal Code
61038
Country
Ukraine
Facility Name
SE "Institute of Dermatology and Venerology of NAMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61057
Country
Ukraine
Facility Name
Rivne Regional Dermatology and Venereology Dispensary
City
Rivne
ZIP/Postal Code
33028
Country
Ukraine
Facility Name
Treatment-diagnostic center PE "Asclepius"
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 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 URL
https://vivli.org/
Learn more about this trial
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
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