Clinical trial NCT03334435: A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: eczema
atopic eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2017-11-07
Enrollment: 1645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.


Eligibility criteria: Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:

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

OR

Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:

Inclusion Criteria:

* Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
* Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
* Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
* Agree to use emollients daily.

Exclusion Criteria:

* Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
* A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
* Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
* Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
* Have been treated with the following therapies:

  * Monoclonal antibody for less than 5 half-lives prior to randomization.
  * Received prior treatment with any oral Janus kinase (JAK) inhibitor.
  * Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
  * Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
* Have high blood pressure characterized by a repeated systolic blood pressure \>160 millimeters of mercury (mm Hg) or diastolic blood pressure \>100 mm Hg.
* Have had major surgery within the past eight weeks or are planning major surgery during the study.
* Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
* Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
* Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
* Have specific laboratory abnormalities.
* Have received certain treatments that are contraindicated.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
timeFrame: Weeks 16, 36 and 52
measure: RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
timeFrame: Weeks 16, 36, and 52
Secondary outcomes:
measure: RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
timeFrame: Weeks 16, 36, and 52
measure: RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
timeFrame: Weeks 16, 36, and 52
measure: Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
timeFrame: Weeks 16, 36 and 52
measure: NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
timeFrame: Weeks 16, 36, and 52
measure: NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
timeFrame: Weeks 16, 36, 52
measure: NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
timeFrame: Weeks 16, 36, and 52
measure: RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
timeFrame: Weeks 16, 36, and 52 Weeks
measure: RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
timeFrame: Weeks 16, 36, and 52
measure: NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
timeFrame: Weeks 16, 36, and 52
measure: NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
timeFrame: Weeks 16, 36, and 52
measure: RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)
timeFrame: Week 16
measure: RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
timeFrame: Week 16
measure: NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
timeFrame: Week 16
measure: NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
timeFrame: Week 16
measure: NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
timeFrame: Weeks 4, 16, 24, 52
measure: NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
timeFrame: Week 16
measure: NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
timeFrame: Weeks 68, 104
measure: Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
timeFrame: Weeks 68, 104
measure: Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
timeFrame: Weeks 68, 104
measure: Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
timeFrame: Week 52 Up to Week 200
measure: Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
timeFrame: Weeks 68, 104
measure: Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
timeFrame: Weeks 68, 104
measure: Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
timeFrame: Weeks 68, 104
measure: Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
timeFrame: Week 68
measure: Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
timeFrame: Week 68
measure: Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
timeFrame: Week 68
measure: Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
timeFrame: Week 104
measure: Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
timeFrame: Week 104
measure: Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)
timeFrame: Week 104
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: CEDIC-Centro de Investigaciones Clinicas
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion CIDEA
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto de Neumonología y Dermatología
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Skin & Cancer Foundation Australia
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Adelaide
country: Australia
facility: Clinical Trials SA Pty Ltd
state: South Australia
city: Carlton
country: Australia
facility: Skin and Cancer Foundation Inc.
state: Victoria
city: Perth
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Elisabethinen
state: Oberösterreich
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Wien
country: Austria
facility: KA Rudolfstiftung
city: Wien
country: Austria
facility: AKH
city: Wien
country: Austria
facility: KH Hietzing mit neurologischem Zentrum Rosenhügel
city: Wien
country: Austria
facility: Sozialmed. Zentrum Ost - Donauspital
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
state: Hl. M. Praha
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Hl. M. Praha
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice v Motole
state: Hl. M. Praha
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
state: Hl. M. Praha
city: Brno
country: Czechia
facility: Fakultni Nemocnice U svate Anny
state: Jihomoravský Kraj
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
state: Moravskoslezsky Kraj
city: Plzen-Bory
country: Czechia
facility: Fakultni Nemocnice Plzen
state: Plzeňský Kraj
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora, s.r.o.
state: Středočeský Kraj
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
state: Ustecký Kraj
city: Hellerup
country: Denmark
facility: Gentofte Hospital
state: Region Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitehospital Marselisborg Centret
state: Region Midtjyland
city: Paris
country: France
facility: Hopital Saint-Louis
state: Cedex 10
city: Bordeaux Cedex
country: France
facility: CHU de Bordeaux Hopital Saint Andre
city: Grenoble Cédex 9
country: France
facility: CHU Grenoble Alpes
city: Nantes Cedex 1
country: France
facility: Chru De Nantes Hotel-Dieu
city: Nice cedex 3
country: France
facility: CHU de Nice Hopital de L'Archet
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Toulouse
country: France
facility: Hopital Larrey
city: Freiburg im Breisgau
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Gemeinschaftspraxis Mahlow
state: Brandenburg
city: Darmstadt
country: Germany
facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
state: Mecklenburg-Vorpommern
city: Bramsche
country: Germany
facility: Dermatologisches Zentrum Osnabrück Nord
state: Niedersachsen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Niedersachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitätsklinikum Otto-von-Guericke-Universität
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Praxis Gerlach
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Leipzig
country: Germany
facility: Universität Leipzig - Universitätsklinikum
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Berlin
country: Germany
facility: ISA GmbH
city: Berlin
country: Germany
facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Oroshaza
country: Hungary
facility: Oroshaza Varosi Onkormanyzat Korhaza
state: Bekes
city: Szeged
country: Hungary
facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
state: Hajdu-Bihar
city: Puspokladany
country: Hungary
facility: Trial Pharma Kft.
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz
state: Somogy
city: Szombathely
country: Hungary
facility: Markusovszky Korhaz
state: Vas
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Veszprem
country: Hungary
facility: MedMare Bt
city: Vizag
country: India
facility: King George Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: All India Institue of Medical Sciences (AIIMS)
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Panchshil Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Byramjee Jeejeebhoy Medical College & Civil Hospital
state: Gujarat
city: Navi Mumbai
country: India
facility: Dr. D. Y. Patil Medical College & Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharshtra
city: Secunderabad
country: India
facility: Gandhi Hospital
state: Telangana
city: Afula
country: Israel
facility: Haemek Medical Center- Dermatology
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
state: Lazio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Pisa
country: Italy
facility: Azienda Ospedaliera - Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico di Tor Vergata
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma
city: Vicenza
country: Italy
facility: ULSS 8
city: Ainokawa, Ichikawa-shi
country: Japan
facility: Yanagihara dermatology clinic
state: Chiba
city: Ichikawa-shi
country: Japan
facility: Kawashima Dermatology Clinic
state: Chiba
city: Matsudo-shi
country: Japan
facility: Medical Corporation Soleil Miyata Dermatology Clinic
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Fumimori Clinic
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-ken
city: Sapporo
country: Japan
facility: Shibaki Dermatology Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
state: Hokkaido
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Nishi-ku, Yokohama-city
country: Japan
facility: Queen's Square Dermatology and Allergology
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Kashima-machi, Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Neyagawa-shi
country: Japan
facility: Yoshioka Dermatology Clinic
state: Osaka
city: Nishi-ku Sakai-shi
country: Japan
facility: Kume Clinic
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Senri-Chuo Hanafusa Dermatology Clinic
state: Osaka
city: Ohmiya-ku,Saitama-shi
country: Japan
facility: Sanrui Dermatology Clinic
state: Saitama
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Hamamatsu-shi
country: Japan
facility: JA Shizuoka Kohseiren Enshu Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Iidabashi Clinic
state: Tokyo
city: Chiyoda-Ku
country: Japan
facility: Tokyo Teishin Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Hosono Clinic
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Sumire Dermatology Clinic
state: Tokyo
city: Nerima-ku
country: Japan
facility: Oizumi Hanawa Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Naoko Dermatology Clinic
state: Tokyo
city: Shinagawa-KU
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku
country: Japan
facility: Yamate Dermatological Clinic
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Shirasaki Clinic
state: Toyama
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi Do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Korea
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: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Mexico City
country: Mexico
facility: Hospital de Jesus I.A.P.
state: Distrito Federal
city: México City
country: Mexico
facility: Grupo Medico Camino S.C.
state: Distrito Federal
city: Morelia
country: Mexico
facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales
state: Michoacan Morelia
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion S.C.
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: Cuernavaca
country: Mexico
facility: JM Research S.C.
city: Distrito Federal
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C
city: Osielsko
country: Poland
facility: DermoDent, Centrum Medyczne Czajkowscy
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o.
state: Lodzkie
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
state: Lubelskie
city: Krakow
country: Poland
facility: Barbara Rewerska DIAMOND CLINIC
state: Malopolskie
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny CSK MON
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych, PI House
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Slaskie
city: Olsztyn
country: Poland
facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
state: Warminsko-mazurskie
city: Szczecin
country: Poland
facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie
state: Zachodniopomorskie
city: Krasnodar
country: Russian Federation
facility: GBUZ Clinical dermatology and venereological dispensary
state: Krasnodarskiy Kray
city: Moscow
country: Russian Federation
facility: State scientific centre for dermatovenerology and cosmetolog
city: Moscow
country: Russian Federation
facility: Russian state medical-stomatological university n.a. Evdokimov
city: Saint-Petersburg
country: Russian Federation
facility: LLC ArsVitae NorthWest
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Center "Kurator"
city: St. Petersburg
country: Russian Federation
facility: SPb SBHI Skin-venerologic dispensary #10
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Badalona
city: Mostoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria De Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital De Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Centro de Especialidades Mollabao
city: Lausanne
country: Switzerland
facility: CHUV Centre Hospitalier Universitaire Vaudois
state: Vaud
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Genève
country: Switzerland
facility: HUG-Hôpitaux Universitaires de Genève
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung
city: New Taipei City
country: Taiwan
facility: Taipei Medical University- Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital - Taipei
city: Taoyuan, (r.o.c.)
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
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:
citation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
citation: Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.
citation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.