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Clinical Trial Details for A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis


Eli Lilly and Company
NCT ID: NCT03334435
Last Updated: November 4, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 18 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Eli Lilly and Company
  • Location: Not Provided

Official Title

A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

Purpose

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

– Have completed the final active treatment visit for an originating study eligible to
enroll participants directly into study BREEZE-AD3 OR

– Meet criteria for NCT03334396 or NCT03334422.

Exclusion Criteria:

– Had investigational product permanently discontinued at any time during a previous
baricitinib study.

– Had temporary investigational product interruption continue at the final study visit
of a previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the participant’s participation in the study.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Eli Lilly and Company

Incyte Corporation

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Please refer to this study by its ClinicalTrials.gov identifier: NCT03334435

Location

Contacts

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires C1425DES

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1027AAP

Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, C1055AA0

Argentina

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, C1121ABE

Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, C1425BEA

Argentina

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, C1425DKG

Argentina

Parra Dermatología

Mendoza, 5500

Argentina

Woden Dermatology

Phillip, Australian Capital Territory 2606

Australia

Skin & Cancer Foundation Australia

Westmead, New South Wales 2145

Australia

The Skin Centre

Benowa, Queensland 4217

Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland 4102

Australia

Clinical Trials SA Pty Ltd

Adelaide, South Australia 5073

Australia

Skin and Cancer Foundation Inc.

Carlton, Victoria 3053

Australia

Fremantle Dermatology

Perth, Western Australia 6160

Australia

Ordensklinikum Linz GmbH - Elisabethinen

Linz, Oberösterreich 4020

Austria

Universitätsklinikum Graz

Graz, Steiermark 8036

Austria

KA Rudolfstiftung

Wien, 1030

Austria

AKH

Wien, 1090

Austria

KH Hietzing mit neurologischem Zentrum Rosenhügel

Wien, 1130

Austria

Sozialmed. Zentrum Ost - Donauspital

Wien, 1220

Austria

Clintrial, s.r.o.

Praha 10, Hl. M. Praha 100 00

Czechia

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Hl. M. Praha 100 34

Czechia

Fakultni Nemocnice v Motole

Praha 5, Hl. M. Praha 150 06

Czechia

Nemocnice Na Bulovce

Praha 8, Hl. M. Praha 180 81

Czechia

Fakultni Nemocnice U svate Anny

Brno, Jihomoravský Kraj 656 91

Czechia

Nemocnice Novy Jicin a.s.

Novy Jicin, Moravskoslezsky Kraj 741 01

Czechia

Fakultni Nemocnice Plzen

Plzen-Bory, Plzeňský Kraj 305 99

Czechia

Kozni ambulance Kutna Hora, s.r.o.

Kutna Hora, Středočeský Kraj 28401

Czechia

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

Usti nad Labem, Ustecký Kraj 40113

Czechia

Gentofte Hospital

Hellerup, Region Hovedstaden 2900

Denmark

Aarhus Universitehospital Marselisborg Centret

Aarhus, Region Midtjyland 8200

Denmark

Hopital Saint-Louis

Paris, Cedex 10 75475

France

CHU de Bordeaux Hopital Saint Andre

Bordeaux Cedex, 33075

France

CHU Grenoble Alpes

Grenoble Cédex 9, 38043

France

Chru De Nantes Hotel-Dieu

Nantes Cedex 1, 44093

France

CHU de Nice Hopital de L'Archet

Nice cedex 3, 06202

France

Centre Hospitalier Lyon Sud

Pierre Benite Cedex, 69495

France

Hopital Larrey

Toulouse, 31059

France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Württemberg 79104

Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Württemberg 69120

Germany

Klinikum der Universität München

München, Bayern 80337

Germany

Gemeinschaftspraxis Mahlow

Blankenfelde-Mahlow, Brandenburg 15831

Germany

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

Darmstadt, Hessen 64283

Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hessen 60590

Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern 18057

Germany

Dermatologisches Zentrum Osnabrück Nord

Bramsche, Niedersachsen 49565

Germany

Universitätsmedizin Göttingen

Göttingen, Niedersachsen 37075

Germany

Universitätsklinikum Bonn

Bonn, Nordrhein-Westfalen 53127

Germany

Universitaetsklinikum Essen

Essen, Nordrhein-Westfalen 45147

Germany

Universitätsklinikum Otto-von-Guericke-Universität

Magdeburg, Sachsen-Anhalt 39120

Germany

Praxis Gerlach

Dresden, Sachsen 01097

Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Sachsen 01307

Germany

Universität Leipzig - Universitätsklinikum

Leipzig, Sachsen 04103

Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein 24105

Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein 23538

Germany

Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik

Aachen, 52074

Germany

Charité Universitätsmedizin Berlin

Berlin, 10117

Germany

Rothhaar Studien GmbH

Berlin, 10783

Germany

ISA GmbH

Berlin, 10789

Germany

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, 13055

Germany

TFS Trial Form Support GmbH

Hamburg, 20537

Germany

Oroshaza Varosi Onkormanyzat Korhaza

Oroshaza, Bekes 5900

Hungary

SZTE AOK Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrad 6720

Hungary

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

Debrecen, Hajdu-Bihar 4032

Hungary

Trial Pharma Kft.

Puspokladany, Hajdu-Bihar 4150

Hungary

Allergo-Derm Bakos Kft

Szolnok, Jasz-Nagykun-Szolnok 5000

Hungary

Kaposi Mor Oktato Korhaz

Kaposvar, Somogy 7400

Hungary

Markusovszky Korhaz

Szombathely, Vas 9700

Hungary

UNO Medical Trials Kft.

Budapest, 1135

Hungary

MedMare Bt

Veszprem, 8200

Hungary

King George Hospital

Vizag, Andhra Pradesh 530002

India

All India Institue of Medical Sciences (AIIMS)

New Delhi, Delhi 110 029

India

Sir Ganga Ram Hospital

New Delhi, Delhi 110060

India

Panchshil Hospital

Ahmedabad, Gujarat 380005

India

Byramjee Jeejeebhoy Medical College & Civil Hospital

Ahmedabad, Gujarat 380016

India

Dr. D. Y. Patil Medical College & Hospital

Navi Mumbai, Maharashtra 400706

India

Seth GS Medical College & KEM Hospital

Mumbai, Maharshtra 400012

India

Chennai Meenakshi Multispeciality Hospital

Chennai, Tamil Nadu 600004

India

Gandhi Hospital

Secunderabad, Telangana 500003

India

Haemek Medical Center- Dermatology

Afula, 1834111

Israel

Rambam Medical Center

Haifa, 3525408

Israel

Hadassah Medical Center Ethics Committee

Jerusalem, 91220

Israel

Rabin Medical Center

Petach Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5265601

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Policlinico Univ. Agostino Gemelli

Roma, Lazio 00168

Italy

Istituto Clinico Humanitas

Rozzano, Milano 20089

Italy

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

Genova, 16132

Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131

Italy

Azienda Ospedaliera - Universitaria Pisana

Pisa, 56126

Italy

Policlinico di Tor Vergata

Roma, 00133

Italy

Ospedale Policlinico Giambattista Rossi, Borgo Roma

Verona, 37134

Italy

ULSS 8

Vicenza, 36100

Italy

Yanagihara dermatology clinic

Ainokawa, Ichikawa-shi, Chiba 272-0143

Japan

Kawashima Dermatology Clinic

Ichikawa-shi, Chiba 272-0033

Japan

Medical Corporation Soleil Miyata Dermatology Clinic

Matsudo-shi, Chiba 271-0092

Japan

Fumimori Clinic

Fukuoka-shi, Fukuoka 815-0082

Japan

Kurume University Hospital

Kurume, Fukuoka 830 0011

Japan

Hiroshima University Hospital

Hiroshima-shi, Hiroshima-ken 734-8551

Japan

Shibaki Dermatology Clinic

Sapporo, Hokkaido 006 0022

Japan

Sapporo Skin Clinic

Sapporo, Hokkaido 060-0063

Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki 300-0395

Japan

Queen's Square Dermatology and Allergology

Nishi-ku, Yokohama-city, Kanagawa 220-6208

Japan

Nomura Dermatology Clinic

Yokohama-shi, Kanagawa 221-0825

Japan

Yokohama City Minato Red Cross Hospital

Yokohama-shi, Kanagawa 231-8682

Japan

Noguchi Dermatology

Kashima-machi, Kamimashiki-gun, Kumamoto 861-3101

Japan

Kyoto Prefectural University of Medicine

Kyoto-shi, Kyoto 602-8566

Japan

Osaka Habikino Medical Center

Habikino, Osaka 583-8588

Japan

Yoshioka Dermatology Clinic

Neyagawa-shi, Osaka 572-0838

Japan

Kume Clinic

Nishi-ku Sakai-shi, Osaka 593-8324

Japan

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka-shi, Osaka 560-0085

Japan

Sanrui Dermatology Clinic

Ohmiya-ku,Saitama-shi, Saitama 330-0854

Japan

Shimane University Hospital

Izumo, Shimane 693-8501

Japan

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu-shi, Shizuoka 430-0929

Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi 329-0498

Japan

Iidabashi Clinic

Chiyoda-ku, Tokyo 102-0072

Japan

Tokyo Teishin Hospital

Chiyoda-Ku, Tokyo 102-8798

Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo 103-0025

Japan

Hosono Clinic

Chuo-ku, Tokyo 104-0031

Japan

Sumire Dermatology Clinic

Edogawa-ku, Tokyo 133-0057

Japan

Oizumi Hanawa Clinic

Nerima-ku, Tokyo 178-0063

Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo 158-0097

Japan

NTT Medical Center Tokyo

Shinagawa-KU, Tokyo 141-8625

Japan

Yamate Dermatological Clinic

Shinjuku, Tokyo 169-0075

Japan

Tachikawa Dermatology Clinic

Tachikawa-shi, Tokyo 190-0023

Japan

Shirasaki Clinic

Takaoka-shi, Toyama 9330871

Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi 400-8506

Japan

Gifu University Hospital

Gifu, 501-1194

Japan

Osaka City University Hospital

Osaka, 545-8586

Japan

Ajou University Hospital

Suwon, Gyeonggi Do 16499

Korea, Republic of

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do 15355

Korea, Republic of

Dongguk University Ilsan Hospital

Goyang, Gyeonggi-do 10326

Korea, Republic of

Gachon University Gil Medical Center

Incheon, Korea 21565

Korea, Republic of

Severance Hospital Yonsei University Health System

Seoul, 03722

Korea, Republic of

Konkuk University Medical Center

Seoul, 05030

Korea, Republic of

Seoul St. Mary's Hospital

Seoul, 06591

Korea, Republic of

Chungang University Hospital

Seoul, 06973

Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441

Korea, Republic of

Hospital de Jesus I.A.P.

Mexico City, Distrito Federal 06090

Mexico

Grupo Medico Camino S.C.

México City, Distrito Federal 03310

Mexico

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, Michoacan Morelia CP 58249

Mexico

CRI Centro Regiomontano de Investigacion S.C.

Monterrey, Nuevo Leon 64060

Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León 64460

Mexico

JM Research S.C.

Cuernavaca, 62290

Mexico

RM Pharma Specialists S.A. de C.V.

Distrito Federal, 3100

Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, 34000

Mexico

DermoDent, Centrum Medyczne Czajkowscy

Osielsko, Kujawsko-pomorskie 86-031

Poland

Dermed Centrum Medyczne Sp. z o.o.

Lodz, Lodzkie 90-265

Poland

Lubelskie Centrum Diagnostyczne

Swidnik, Lubelskie 21-040

Poland

Barbara Rewerska DIAMOND CLINIC

Krakow, Malopolskie 31-559

Poland

Wojskowy Instytut Medyczny CSK MON

Warsaw, Mazowieckie 04-141

Poland

Centrum Medyczne AMED

Warszawa, Mazowieckie 01-518

Poland

Centralny Szpital Kliniczny MSWia Klinika Dermatologiczna

Warszawa, Mazowieckie 02-507

Poland

Centrum Medyczne Evimed

Warszawa, Mazowieckie 02-625

Poland

NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

Bialystok, Podlaskie 15-375

Poland

Centrum Badan Klinicznych, PI House

Gdansk, Pomorskie 80-546

Poland

Centrum Medyczne Angelius Provita

Katowice, Slaskie 40-611

Poland

Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

Olsztyn, Warminsko-mazurskie 10-229

Poland

LASER CLINIC Specjalistyczne Gabinety Lekarskie

Szczecin, Zachodniopomorskie 70-332

Poland

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, Krasnodarskiy Kray 350020

Russian Federation

State scientific centre for dermatovenerology and cosmetolog

Moscow, 107076

Russian Federation

Russian state medical-stomatological university n.a. Evdokimov

Moscow, 111398

Russian Federation

LLC ArsVitae NorthWest

Saint-Petersburg, 194223

Russian Federation

LLC Medical Center "Kurator"

Saint-Petersburg, 196240

Russian Federation

SPb SBHI Skin-venerologic dispensary #10

St. Petersburg, 194021

Russian Federation

Hospital Germans Trias i Pujol

Barcelona, Badalona 08916

Spain

Hospital Universitario Rey Juan Carlos

Mostoles, Madrid 28933

Spain

Clinica Universitaria De Navarra

Pamplona, Navarra 31008

Spain

Hospital General Universitario Alicante

Alicante, 03010

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010

Spain

Hospital Infanta Leonor

Madrid, 28031

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Centro de Especialidades Mollabao

Pontevedra, 36001

Spain

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Vaud 1011

Switzerland

Inselspital Bern

Bern, 3010

Switzerland

HUG-Hôpitaux Universitaires de Genève

Genève, 1205

Switzerland

Universitätsspital Zürich

Zürich, 8091

Switzerland

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung, 83301

Taiwan

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 23561

Taiwan

Chung Shan Medical University Hospital

Taichung City, 40201

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei City, 10048

Taiwan

Chang Gung Memorial Hospital - Taipei

Taipei City, 10508

Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, (r.o.c.), 33342

Taiwan