Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (BREEZE-AD3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334435
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : January 17, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Baricitinib Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : September 2, 2021
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Baricitinib High Dose Nonresponders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib High Dose Nonresponders Rescued
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Mid Dose Nonresponders Rescued
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib High Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Mid Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Low Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Placebo Comparator: Placebo Responders
Placebo administered orally.
Drug: Placebo
Administered orally

Experimental: Baricitinib Open Label Extension
Baricitinib administered orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104




Primary Outcome Measures :
  1. Proportion of Participants with a Response of Investigator's Global Assessment (IGA) 0 or 1 at 16 Weeks [ Time Frame: 16 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 16 weeks

  2. Proportion of Participants with a Response of IGA 0 or 1 at 36 Weeks [ Time Frame: 36 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 36 weeks

  3. Proportion of Participants with a Response of IGA 0 or 1 at 52 Weeks [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 52 weeks


Secondary Outcome Measures :
  1. Proportion of Participants Achieving IGA 0, 1 or 2 [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0,1 or 2

  2. Proportion of Participants Achieving IGA 0 or 1 (non-responders) [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0 or 1

  3. Proportion of Participants Achieving Response of Eczema Area and Severity Index (EASI)75 from Baseline of Originating Study [ Time Frame: 52 Weeks ]
    Proportion of participants achieving response of EASI75 from baseline of originating study

  4. Proportion of Participants with a 4-Point Improvement from Baseline of Originating Study in Itch NRS [ Time Frame: 16 Weeks ]
    Proportion of participants with a 4 point improvement from baseline of originating study in Itch NRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334435


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Hide Hide 187 study locations
Layout table for location information
Argentina
CEDIC-Centro de Investigaciones Clinicas Active, not recruiting
Caba, Buenos Aires, Argentina, C1425DES
Centro de Investigaciones Metabólicas (CINME) Active, not recruiting
Buenos Aires, Argentina, C1027AAP
Buenos Aires Skin Active, not recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
Fundacion CIDEA Active, not recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1121ABE
Instituto de Neumonología y Dermatología Active, not recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
Psoriahue Medicina Interdisciplinaria Active, not recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
Parra Dermatología Active, not recruiting
Mendoza, Argentina, 5500
Australia, Australian Capital Territory
Woden Dermatology Active, not recruiting
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Skin & Cancer Foundation Australia Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
The Skin Centre Active, not recruiting
Benowa, Queensland, Australia, 4217
Veracity Clinical Research Pty Ltd Active, not recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Clinical Trials SA Pty Ltd Active, not recruiting
Adelaide, South Australia, Australia, 5073
Australia, Victoria
Skin and Cancer Foundation Inc. Active, not recruiting
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Fremantle Dermatology Active, not recruiting
Perth, Western Australia, Australia, 6160
Austria
Ordensklinikum Linz GmbH - Elisabethinen Active, not recruiting
Linz, Oberösterreich, Austria, 4020
Universitätsklinikum Graz Active, not recruiting
Graz, Steiermark, Austria, 8036
KA Rudolfstiftung Active, not recruiting
Wien, Austria, 1030
AKH Active, not recruiting
Wien, Austria, 1090
KH Hietzing mit neurologischem Zentrum Rosenhügel Active, not recruiting
Wien, Austria, 1130
Sozialmed. Zentrum Ost - Donauspital Active, not recruiting
Wien, Austria, 1220
Czechia
Clintrial, s.r.o. Active, not recruiting
Praha 10, Hl. M. Praha, Czechia, 100 00
Fakultni nemocnice Kralovske Vinohrady Active, not recruiting
Praha 10, Hl. M. Praha, Czechia, 100 34
Fakultni Nemocnice v Motole Active, not recruiting
Praha 5, Hl. M. Praha, Czechia, 150 06
Nemocnice Na Bulovce Active, not recruiting
Praha 8, Hl. M. Praha, Czechia, 180 81
Fakultni Nemocnice U svate Anny Active, not recruiting
Brno, Jihomoravský Kraj, Czechia, 656 91
Nemocnice Novy Jicin a.s. Active, not recruiting
Novy Jicin, Moravskoslezsky Kraj, Czechia, 741 01
Fakultni Nemocnice Plzen Active, not recruiting
Plzen-Bory, Plzeňský Kraj, Czechia, 305 99
Kozni ambulance Kutna Hora, s.r.o. Active, not recruiting
Kutna Hora, Středočeský Kraj, Czechia, 28401
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Active, not recruiting
Usti nad Labem, Ustecký Kraj, Czechia, 40113
Denmark
Gentofte Hospital Active, not recruiting
Hellerup, Region Hovedstaden, Denmark, 2900
Aarhus Universitehospital Marselisborg Centret Active, not recruiting
Aarhus, Region Midtjyland, Denmark, 8200
France
Hopital Saint-Louis Active, not recruiting
Paris, Cedex 10, France, 75475
CHU de Bordeaux Hopital Saint Andre Active, not recruiting
Bordeaux Cedex, France, 33075
CHU Grenoble Alpes Active, not recruiting
Grenoble Cédex 9, France, 38043
Chru De Nantes Hotel-Dieu Active, not recruiting
Nantes Cedex 1, France, 44093
CHU de Nice Hopital de L'Archet Active, not recruiting
Nice cedex 3, France, 06202
Centre Hospitalier Lyon Sud Active, not recruiting
Pierre Benite Cedex, France, 69495
Hopital Larrey Active, not recruiting
Toulouse, France, 31059
Germany
Universitätsklinikum Freiburg Active, not recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79104
Universitätsklinikum Heidelberg Active, not recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Klinikum der Universität München Active, not recruiting
München, Bayern, Germany, 80337
Gemeinschaftspraxis Mahlow Active, not recruiting
Blankenfelde-Mahlow, Brandenburg, Germany, 15831
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH Active, not recruiting
Darmstadt, Hessen, Germany, 64283
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Active, not recruiting
Frankfurt am Main, Hessen, Germany, 60590
Universitätsmedizin Rostock Active, not recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Dermatologisches Zentrum Osnabrück Nord Active, not recruiting
Bramsche, Niedersachsen, Germany, 49565
Universitätsmedizin Göttingen Active, not recruiting
Göttingen, Niedersachsen, Germany, 37075
Universitätsklinikum Bonn Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53127
Contact    4922828716248      
Principal Investigator: Hans-Jürgen Kammler         
Universitaetsklinikum Essen Active, not recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Universitätsklinikum Otto-von-Guericke-Universität Active, not recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Praxis Gerlach Active, not recruiting
Dresden, Sachsen, Germany, 01097
Universitätsklinikum Carl Gustav Carus Active, not recruiting
Dresden, Sachsen, Germany, 01307
Universität Leipzig - Universitätsklinikum Active, not recruiting
Leipzig, Sachsen, Germany, 04103
Universitätsklinikum Schleswig-Holstein Active, not recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Schleswig-Holstein Active, not recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik Active, not recruiting
Aachen, Germany, 52074
Charité Universitätsmedizin Berlin Active, not recruiting
Berlin, Germany, 10117
Rothhaar Studien GmbH Active, not recruiting
Berlin, Germany, 10783
ISA GmbH Active, not recruiting
Berlin, Germany, 10789
Praxis für Ganzheitliche Dermatologie im Ärztehaus Active, not recruiting
Berlin, Germany, 13055
TFS Trial Form Support GmbH Active, not recruiting
Hamburg, Germany, 20537
Hungary
Oroshaza Varosi Onkormanyzat Korhaza Active, not recruiting
Oroshaza, Bekes, Hungary, 5900
SZTE AOK Borgyogyaszati es Allergologiai Klinika Active, not recruiting
Szeged, Csongrad, Hungary, 6720
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika Active, not recruiting
Debrecen, Hajdu-Bihar, Hungary, 4032
Trial Pharma Kft. Active, not recruiting
Puspokladany, Hajdu-Bihar, Hungary, 4150
Allergo-Derm Bakos Kft Active, not recruiting
Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
Kaposi Mor Oktato Korhaz Active, not recruiting
Kaposvar, Somogy, Hungary, 7400
Markusovszky Korhaz Active, not recruiting
Szombathely, Vas, Hungary, 9700
UNO Medical Trials Kft. Active, not recruiting
Budapest, Hungary, 1135
MedMare Bt Active, not recruiting
Veszprem, Hungary, 8200
India
King George Hospital Active, not recruiting
Vizag, Andhra Pradesh, India, 530002
All India Institue of Medical Sciences (AIIMS) Active, not recruiting
New Delhi, Delhi, India, 110 029
Sir Ganga Ram Hospital Active, not recruiting
New Delhi, Delhi, India, 110060
Panchshil Hospital Active, not recruiting
Ahmedabad, Gujarat, India, 380005
Byramjee Jeejeebhoy Medical College & Civil Hospital Active, not recruiting
Ahmedabad, Gujarat, India, 380016
Dr. D. Y. Patil Medical College & Hospital Active, not recruiting
Navi Mumbai, Maharashtra, India, 400706
Seth GS Medical College & KEM Hospital Active, not recruiting
Mumbai, Maharshtra, India, 400012
Chennai Meenakshi Multispeciality Hospital Recruiting
Chennai, Tamil Nadu, India, 600004
Contact    9144 42938938      
Principal Investigator: Jayaraaman Murugaiya         
Gandhi Hospital Active, not recruiting
Secunderabad, Telangana, India, 500003
Israel
Haemek Medical Center- Dermatology Active, not recruiting
Afula, Israel, 1834111
Rambam Medical Center Active, not recruiting
Haifa, Israel, 3525408
Hadassah Medical Center Ethics Committee Active, not recruiting
Jerusalem, Israel, 91220
Rabin Medical Center Active, not recruiting
Petach Tikva, Israel, 4941492
Sheba Medical Center Active, not recruiting
Ramat Gan, Israel, 5265601
Tel Aviv Sourasky Medical Center Active, not recruiting
Tel Aviv, Israel, 6423906
Italy
Policlinico Univ. Agostino Gemelli Active, not recruiting
Roma, Lazio, Italy, 00168
Istituto Clinico Humanitas Active, not recruiting
Rozzano, Milano, Italy, 20089
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova Active, not recruiting
Genova, Italy, 16132
Azienda Ospedaliera Universitaria Federico II Completed
Napoli, Italy, 80131
Azienda Ospedaliera - Universitaria Pisana Active, not recruiting
Pisa, Italy, 56126
Policlinico di Tor Vergata Active, not recruiting
Roma, Italy, 00133
Ospedale Policlinico Giambattista Rossi, Borgo Roma Completed
Verona, Italy, 37134
ULSS 8 Active, not recruiting
Vicenza, Italy, 36100
Japan
Yanagihara dermatology clinic Active, not recruiting
Ainokawa, Ichikawa-shi, Chiba, Japan, 272-0143
Kawashima Dermatology Clinic Active, not recruiting
Ichikawa-shi, Chiba, Japan, 272-0033
Medical Corporation Soleil Miyata Dermatology Clinic Active, not recruiting
Matsudo-shi, Chiba, Japan, 271-0092
Fumimori Clinic Active, not recruiting
Fukuoka-shi, Fukuoka, Japan, 815-0082
Kurume University Hospital Active, not recruiting
Kurume, Fukuoka, Japan, 830 0011
Hiroshima University Hospital Active, not recruiting
Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
Shibaki Dermatology Clinic Active, not recruiting
Sapporo, Hokkaido, Japan, 006 0022
Sapporo Skin Clinic Active, not recruiting
Sapporo, Hokkaido, Japan, 060-0063
Tokyo Medical University Ibaraki Medical Center Active, not recruiting
Inashiki-gun, Ibaraki, Japan, 300-0395
Queen's Square Dermatology and Allergology Active, not recruiting
Nishi-ku, Yokohama-city, Kanagawa, Japan, 220-6208
Nomura Dermatology Clinic Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 221-0825
Yokohama City Minato Red Cross Hospital Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 231-8682
Noguchi Dermatology Active, not recruiting
Kashima-machi, Kamimashiki-gun, Kumamoto, Japan, 861-3101
Kyoto Prefectural University of Medicine Active, not recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Osaka Habikino Medical Center Active, not recruiting
Habikino, Osaka, Japan, 583-8588
Yoshioka Dermatology Clinic Active, not recruiting
Neyagawa-shi, Osaka, Japan, 572-0838
Kume Clinic Active, not recruiting
Nishi-ku Sakai-shi, Osaka, Japan, 593-8324
Senri-Chuo Hanafusa Dermatology Clinic Active, not recruiting
Toyonaka-shi, Osaka, Japan, 560-0085
Sanrui Dermatology Clinic Active, not recruiting
Ohmiya-ku,Saitama-shi, Saitama, Japan, 330-0854
Shimane University Hospital Active, not recruiting
Izumo, Shimane, Japan, 693-8501
JA Shizuoka Kohseiren Enshu Hospital Active, not recruiting
Hamamatsu-shi, Shizuoka, Japan, 430-0929
Jichi Medical University Hospital Active, not recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Iidabashi Clinic Active, not recruiting
Chiyoda-ku, Tokyo, Japan, 102-0072
Tokyo Teishin Hospital Active, not recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8798
Nihonbashi Sakura Clinic Active, not recruiting
Chuo-ku, Tokyo, Japan, 103-0025
Hosono Clinic Active, not recruiting
Chuo-ku, Tokyo, Japan, 104-0031
Sumire Dermatology Clinic Active, not recruiting
Edogawa-ku, Tokyo, Japan, 133-0057
Oizumi Hanawa Clinic Active, not recruiting
Nerima-ku, Tokyo, Japan, 178-0063
Naoko Dermatology Clinic Active, not recruiting
Setagaya-ku, Tokyo, Japan, 158-0097
NTT Medical Center Tokyo Active, not recruiting
Shinagawa-KU, Tokyo, Japan, 141-8625
Yamate Dermatological Clinic Active, not recruiting
Shinjuku, Tokyo, Japan, 169-0075
Tachikawa Dermatology Clinic Active, not recruiting
Tachikawa-shi, Tokyo, Japan, 190-0023
Shirasaki Clinic Active, not recruiting
Takaoka-shi, Toyama, Japan, 9330871
Yamanashi Prefectural Central Hospital Active, not recruiting
Kofu, Yamanashi, Japan, 400-8506
Gifu University Hospital Active, not recruiting
Gifu, Japan, 501-1194
Osaka City University Hospital Active, not recruiting
Osaka, Japan, 545-8586
Korea, Republic of
Ajou University Hospital Active, not recruiting
Suwon, Gyeonggi Do, Korea, Republic of, 16499
Korea University Ansan Hospital Active, not recruiting
Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
Dongguk University Ilsan Hospital Active, not recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 10326
Gachon University Gil Medical Center Active, not recruiting
Incheon, Korea, Korea, Republic of, 21565
Severance Hospital Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Konkuk University Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05030
Seoul St. Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 06591
Chungang University Hospital Active, not recruiting
Seoul, Korea, Republic of, 06973
Hallym University Kangnam Sacred Heart Hospital Active, not recruiting
Seoul, Korea, Republic of, 07441
Mexico
Hospital de Jesus I.A.P. Active, not recruiting
Mexico City, Distrito Federal, Mexico, 06090
Grupo Medico Camino S.C. Active, not recruiting
México City, Distrito Federal, Mexico, 03310
Clinica De Enfermedades Cronicas y Procedimientos Especiales Active, not recruiting
Morelia, Michoacan Morelia, Mexico, CP 58249
CRI Centro Regiomontano de Investigacion S.C. Active, not recruiting
Monterrey, Nuevo Leon, Mexico, 64060
Hospital Universitario Dr. Jose Eleuterio Gonzalez Active, not recruiting
Monterrey, Nuevo León, Mexico, 64460
JM Research S.C. Active, not recruiting
Cuernavaca, Mexico, 62290
RM Pharma Specialists S.A. de C.V. Active, not recruiting
Distrito Federal, Mexico, 3100
Instituto de Investigaciones Aplicadas a la Neurociencia A.C Active, not recruiting
Durango, Mexico, 34000
Poland
DermoDent, Centrum Medyczne Czajkowscy Active, not recruiting
Osielsko, Kujawsko-pomorskie, Poland, 86-031
Dermed Centrum Medyczne Sp. z o.o. Active, not recruiting
Lodz, Lodzkie, Poland, 90-265
Lubelskie Centrum Diagnostyczne Active, not recruiting
Swidnik, Lubelskie, Poland, 21-040
Barbara Rewerska DIAMOND CLINIC Active, not recruiting
Krakow, Malopolskie, Poland, 31-559
Wojskowy Instytut Medyczny CSK MON Active, not recruiting
Warsaw, Mazowieckie, Poland, 04-141
Centrum Medyczne AMED Active, not recruiting
Warszawa, Mazowieckie, Poland, 01-518
Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna Active, not recruiting
Warszawa, Mazowieckie, Poland, 02-507
Centrum Medyczne Evimed Active, not recruiting
Warszawa, Mazowieckie, Poland, 02-625
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm Active, not recruiting
Bialystok, Podlaskie, Poland, 15-375
Centrum Badan Klinicznych, PI House Active, not recruiting
Gdansk, Pomorskie, Poland, 80-546
Centrum Medyczne Angelius Provita Active, not recruiting
Katowice, Slaskie, Poland, 40-611
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii Active, not recruiting
Olsztyn, Warminsko-mazurskie, Poland, 10-229
LASER CLINIC Specjalistyczne Gabinety Lekarskie Active, not recruiting
Szczecin, Zachodniopomorskie, Poland, 70-332
Russian Federation
GBUZ Clinical dermatology and venereological dispensary Active, not recruiting
Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
State scientific centre for dermatovenerology and cosmetolog Active, not recruiting
Moscow, Russian Federation, 107076
Russian state medical-stomatological university n.a. Evdokimov Active, not recruiting
Moscow, Russian Federation, 111398
LLC ArsVitae NorthWest Active, not recruiting
Saint-Petersburg, Russian Federation, 194223
LLC Medical Center "Kurator" Active, not recruiting
Saint-Petersburg, Russian Federation, 196240
SPb SBHI Skin-venerologic dispensary #10 Active, not recruiting
St. Petersburg, Russian Federation, 194021
Spain
Hospital Germans Trias i Pujol Active, not recruiting
Barcelona, Badalona, Spain, 08916
Hospital Universitario Rey Juan Carlos Active, not recruiting
Mostoles, Madrid, Spain, 28933
Clinica Universitaria De Navarra Active, not recruiting
Pamplona, Navarra, Spain, 31008
Hospital General Universitario Alicante Active, not recruiting
Alicante, Spain, 03010
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital De Gran Canaria Dr. Negrin Active, not recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Infanta Leonor Active, not recruiting
Madrid, Spain, 28031
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Active, not recruiting
Madrid, Spain, 28046
Centro de Especialidades Mollabao Active, not recruiting
Pontevedra, Spain, 36001
Switzerland
CHUV Centre Hospitalier Universitaire Vaudois Active, not recruiting
Lausanne, Vaud, Switzerland, 1011
Inselspital Bern Active, not recruiting
Bern, Switzerland, 3010
HUG-Hôpitaux Universitaires de Genève Completed
Genève, Switzerland, 1205
Universitätsspital Zürich Active, not recruiting
Zürich, Switzerland, 8091
Taiwan
Chang Gung Memorial Hospital - Kaohsiung Active, not recruiting
Kaohsiung, Taiwan, 83301
Taipei Medical University- Shuang Ho Hospital Active, not recruiting
New Taipei City, Taiwan, 23561
Chung Shan Medical University Hospital Active, not recruiting
Taichung City, Taiwan, 40201
National Cheng Kung University Hospital Active, not recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Active, not recruiting
Taipei City, Taiwan, 10048
Chang Gung Memorial Hospital - Taipei Active, not recruiting
Taipei City, Taiwan, 10508
Chang Gung Memorial Hospital - Linkou Recruiting
Taoyuan, (r.o.c.), Taiwan, 33342
Contact    88633281200 ext.2216      
Principal Investigator: Wen-Hung Chung         
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03334435    
Other Study ID Numbers: 16587
I4V-MC-JAHN ( Other Identifier: Eli Lilly and Company )
2017-000873-35 ( EudraCT Number )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 17, 2020
Last Verified: January 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
eczema
atopic eczema
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases