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

Atopic Dermatitis Clinical Trial

— ADjoin  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04392154
• Other study ID #: 17789
• Secondary ID: 2020-001211-24J2
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 15, 2020
• Est. completion date: April 16, 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1188
• Est. completion date: April 16, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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-?), 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-?, 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Lebrikizumab
Subcutaneous injection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Dermira, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Estonia,  France,  Germany,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Poland,  Singapore,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit		Baseline to Week 100
Secondary	Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1		Baseline to Week 100
Secondary	Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study		Baseline to Week 100