Clinical trial NCT04392154: Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Dermira, Inc.
First posted: 2020-05-18
Enrollment: 1153
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04, 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.

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, 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.

Primary outcomes:
measure: Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit
timeFrame: Baseline to Week 100
Secondary outcomes:
measure: Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1
timeFrame: Baseline to Week 100
measure: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study
timeFrame: Baseline to Week 100
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama- Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fountain Valley
country: United States
facility: MD Studies
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Laguna Niguel
country: United States
facility: Avance Clinical Trials Inc
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group + Research Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, INC
state: California
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute and Research Center
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials
state: California
city: Palmdale
country: United States
facility: Cura Clinical Research
state: California
city: Poway
country: United States
facility: MD Strategies Research Centers MDSRC
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: San Diego
country: United States
facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology
state: California
city: San Jose
country: United States
facility: Care Access Research
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Cromwell
country: United States
facility: Central Connecticut Dermatology
state: Connecticut
city: Washington
country: United States
facility: Medical Faculty Associates, Inc.
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Skin Research, LLC
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Gainesville
country: United States
facility: The University of Florida Health System
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC
state: Florida
city: Miami Beach
country: United States
facility: C & R Research Services USA
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: Vitae Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Miami
country: United States
facility: Community Research Foundation Inc
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc
state: Georgia
city: Columbus
country: United States
facility: IACT Health - VHC
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin & Cancer Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates LLC
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Shawnee Mission
country: United States
facility: Kansas Medical Clinic, an Elligo Health Research, Inc.
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Univ School of Med
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Fivenson Dermatology
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Dermatology
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Clarkston
country: United States
facility: Michigan Center for Research Company
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Joseph
country: United States
facility: St Joseph Dermatology and Vein Clinic
state: Michigan
city: Fridley
country: United States
facility: Associated Skin Care Specialists
state: Minnesota
city: New Brighton
country: United States
facility: Associated Skin Care Specialists
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Portsmouth
country: United States
facility: ALLCUTIS Research
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
city: New York
country: United States
facility: Icahn Sch of Med at Mt. Sinai
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Watertown
country: United States
facility: Advanced Asthma and Allergy
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Medford
country: United States
facility: Crisor, LLC, Medford office
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sugarloaf
country: United States
facility: DermDox Dermatology Centers
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Peak Research LLC
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Anderson
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center PL
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dripping Springs
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: Innovate Research, LLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Houston
country: United States
facility: Encore Imaging & Medical Research
state: Texas
city: Laredo
country: United States
facility: Cutis Wellness Dermatology
state: Texas
city: Laredo
country: United States
facility: Laredo Dermatology Associates P.A.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology PLLC
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Salt Lake City
country: United States
facility: Velocity Clinical Research - Woseth Dermatology
state: Utah
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Kogarah
country: Australia
facility: The St. George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Westmead
country: Australia
facility: Skin & Cancer Foundation Australia
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast Clinical Trial Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Hectorville
country: Australia
facility: Clinical Trials SA Pty Ltd
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
city: Nedlands
country: Australia
facility: Captain Stirling Medical Centre
city: Haskovo
country: Bulgaria
facility: DCC Sveti Georgi
city: Sofia
country: Bulgaria
facility: Diagnostic and Consultation Center 14
city: Sofia
country: Bulgaria
facility: Alexandrovska University Hospital
city: Sofia
country: Bulgaria
facility: Euro Derma clinic
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: Medical centre Alitera-Med EOOD
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: Cobourg
country: Canada
facility: Skin Health
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials, Inc
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Peterborough
country: Canada
facility: Skin Health
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: International Dermatology Research
state: Quebec
city: Montréal
country: Canada
facility: International Dermatology Research
state: Quebec
city: Talinn
country: Estonia
facility: Vahlberg & Pild OU
city: Tartu
country: Estonia
facility: Kliiniliste uuringute Keskus OU
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE
state: Gironde
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Dijon
country: France
facility: CHU Dijonon
city: La Roche sur Yon
country: France
facility: CHD Vendee
city: Martigues
country: France
facility: Cabinet Médical
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
city: Nice
country: France
facility: CHU de Nice Hopital de L'Archet
city: Paris
country: France
facility: Hopital Saint Louis
city: Toulouse cedex 9
country: France
facility: Hopital Larrey
city: Langenau
country: Germany
facility: Studienzentrum Dr.Beate Schwarz
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Hautarztpraxis am Löwenmarkt
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Dermazentrum Augsburg
state: Bayern
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hesse
city: Osnabrück
country: Germany
facility: Klinische Forschung Osnabrück
state: Lower Saxony
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
state: Niedersachsen
city: Bochum
country: Germany
facility: Hautzentrum im Jahrhunderthaus
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Nordrhein-Westfalen
city: Selters
country: Germany
facility: Company for Medical Study & Service Selters GmbH
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Hautarztpraxis Dr. Gerlach
state: Sachsen
city: Leipzig
country: Germany
facility: Universität Leipzig - Universitätsklinikum
state: Sachsen
city: Dresden
country: Germany
facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
state: Saxony
city: Leipzig
country: Germany
facility: Velocity Clinical Research Leipzig GmbH
state: Saxony
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
state: Thüringen
city: Augsburg
country: Germany
facility: Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: ISA GmbH
city: Berlin
country: Germany
facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg
city: Hamburg
country: Germany
facility: TFS Trial Support Form GmbH
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Riga
country: Latvia
facility: Clinic of Dermatology and STD
city: Riga
country: Latvia
facility: Health and Aesthetics LTD
city: Riga
country: Latvia
facility: Latvian Dermatology Institute
city: Riga
country: Latvia
facility: Health Center 4, Affiliate Diagnostic Center
city: Talsi
country: Latvia
facility: Smite Aija - Doctor Practice in Dermatology Venereology
city: Kaunas
country: Lithuania
facility: JSC "CD8 Alergology Clinic"
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Vilnius
country: Lithuania
facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos
city: Vilnius
country: Lithuania
facility: Jsc Renmeda
city: Vilnius
country: Lithuania
facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"
city: Vilnius
country: Lithuania
facility: JSC Inlita (Santaros CTC)
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Ciudad de Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Federal District
city: Guadalajara
country: Mexico
facility: Grupo Clinico CATEI Sociedad Civil
state: Jalisco
city: Morelia
country: Mexico
facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales
state: Michoacan
city: Merida
country: Mexico
facility: Cemdeicy S.C.P.
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajio
city: Veracruz
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
city: Wrocław
country: Poland
facility: dermMedica Sp. z o.o.
state: Dolnośląskie
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
state: Lodzkie
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
state: Malopolskie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Malopolskie
city: Warsaw
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
state: Mazowieckie
city: Ossy
country: Poland
facility: Labderm s.c.
state: Slaskie
city: Gdansk
country: Poland
facility: Clinica Vitae Sp. z o.o.
state: Woj. Pomorskie
city: Iwonicz Zdroj
country: Poland
facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
state: Wojewodztwo Podkarpackie
city: Szczecin
country: Poland
facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
state: Zachodniopomorskie
city: Bialystok
country: Poland
facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Gdansk
country: Poland
facility: Oddzial Dermatologii COPERNICUS
city: Gdynia
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
city: Katowice
country: Poland
facility: Holsamed
city: Katowice
country: Poland
facility: Holsamed
city: Kielce
country: Poland
facility: Gabinet Dermatlogiczny. Beata Krecisz
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. z o.o.
city: Warszawa
country: Poland
facility: High-Med Prywatny Gabinet Lekarski
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp.z.o.o.
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. Z.O.O.
city: Wroclaw
country: Poland
facility: CityClinic Przychodnia Lekarsko-Psychologiczna
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Śląskie
city: Singapore
country: Singapore
facility: National University Hospital
state: Central Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Kk Women'S and Childrens Hospital
city: Singapore
country: Singapore
facility: National Skin Centre NSC
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalunya [Cataluña]
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao (Bizkaia)
country: Spain
facility: Hospital Universitario Basurto
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Niaosong
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Kaohsiung City
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Poshtova Square 2
country: Ukraine
facility: Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
state: Zaporizhzhya
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
city: Kharkiv
country: Ukraine
facility: SE "Institute of Dermatology and Venerology of NAMS of Ukraine"
city: Rivne
country: Ukraine
facility: Rivne Regional Dermatology and Venereology Dispensary
city: Uzhhorod
country: Ukraine
facility: Treatment-diagnostic center PE "Asclepius"
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: