A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
BREEZE-AD3
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
3 other identifiers
interventional
1,645
18 countries
179
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedStudy Start
First participant enrolled
March 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2020
CompletedResults Posted
Study results publicly available
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedSeptember 3, 2024
August 1, 2024
2.5 years
November 3, 2017
April 14, 2022
August 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36 and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36, and 52
Secondary Outcomes (35)
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Weeks 16, 36, and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
Weeks 16, 36, and 52
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Weeks 16, 36 and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
Weeks 16, 36, 52
- +30 more secondary outcomes
Study Arms (16)
Responders and Partial Responders (RPR)-Placebo
PLACEBO COMPARATORResponders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
RPR-Bari 1-milligram (mg)
EXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
RPR-Bari 2-mg
EXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
RPR-Bari 4-mg
EXPERIMENTALRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Non-responders (NR): Bari 1 mg to 2 mg
EXPERIMENTALNon-responder (NR) \[those not meeting definition of RPR\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 1 mg to 4 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Bari 2 mg to 2 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Bari 2 mg to 4 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Bari 4 mg to 4 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
NR: Placebo to Bari 2 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
NR: Placebo to Bari 4 mg
EXPERIMENTALNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Placebo
PLACEBO COMPARATORParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
Bari 1 mg
EXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
Bari 2 mg
EXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
Bari 4 mg
EXPERIMENTALParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
Bari 2-mg Open-Label Addendum
EXPERIMENTALParticipants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
Interventions
Administered orally
Administered orally
Eligibility Criteria
You may not qualify if:
- 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
- Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following 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.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (185)
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
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
Ordensklinikum Linz GmbH - Elisabethinen
Linz, Upper Austria, 4020, Austria
KA Rudolfstiftung
Vienna, 1030, Austria
AKH
Vienna, 1090, Austria
KH Hietzing mit neurologischem Zentrum Rosenhügel
Vienna, 1130, Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna, 1220, Austria
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, Central Bohemia, 28401, Czechia
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34, Czechia
Fakultni Nemocnice v Motole
Prague, Hl. M. Praha, 150 06, Czechia
Nemocnice Na Bulovce
Prague, Hl. M. Praha, 180 81, Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, Moravskoslezský kraj, 741 01, Czechia
Fakultni Nemocnice Plzen
Plzen-Bory, Plzeň Region, 305 99, Czechia
Fakultni Nemocnice U svate Anny
Brno, South Moravian, 656 91, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, 40113, Czechia
Gentofte Hospital
Hellerup, Capital Region, 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, 33075, France
CHU Grenoble Alpes
Grenoble Cédex 9, 38043, France
Chru De Nantes Hotel-Dieu
Nantes, 44093, France
CHU de Nice Hopital de L'Archet
Nice, 06202, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hopital Larrey
Toulouse, 31059, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum der Universität München
München, Bavaria, 80337, Germany
Gemeinschaftspraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15831, Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, 49565, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075, Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Praxis Gerlach
Dresden, Saxony, 01097, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Otto-von-Guericke-Universität
Magdeburg, Saxony-Anhalt, 39120, 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
Orosháza, Bekes County, 5900, Hungary
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Trial Pharma Kft.
Püspökladány, Hajdú-Bihar, 4150, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, Somogy County, 7400, Hungary
Markusovszky Korhaz
Szombathely, Vas County, 9700, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
MedMare Bt
Veszprém, 8200, Hungary
King George Hospital
Vizag, Andhra Pradesh, 530002, 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
All India Institue of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110 029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Gandhi Hospital
Secunderabad, Telangana, 500003, India
Haemek Medical Center- Dermatology
Afula, 1834111, Israel
Rambam Medical Center
Haifa, 3525408, Israel
Hadassah Medical Center
Jerusalem, 91220, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Policlinico Univ. Agostino Gemelli
Rome, 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, Fukuoka, 815-0082, Japan
Kurume University Hospital
Kurume, Fukuoka, 830 0011, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 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, Kanagawa, 221-0825, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682, Japan
Noguchi Dermatology
Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3101, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Yoshioka Dermatology Clinic
Neyagawa, 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, 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
Grupo Medico Camino S.C.
Mexico City, Mexico City, 03310, Mexico
Hospital de Jesus I.A.P.
Mexico City, Mexico City, 06090, Mexico
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia, Michoacan Morelia, CP 58249, Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, 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, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
Barbara Rewerska DIAMOND CLINIC
Krakow, Lesser Poland Voivodeship, 31-559, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, Lublin Voivodeship, 21-040, Poland
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, 01-518, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, Masovian Voivodeship, 02-507, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
Wojskowy Instytut Medyczny CSK MON
Warsaw, Masovian Voivodeship, 04-141, Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, Podlaskie Voivodeship, 15-375, Poland
Centrum Badan Klinicznych, PI House
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
Olsztyn, Warmian-Masurian Voivodeship, 10-229, Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, West Pomeranian Voivodeship, 70-332, Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265, Poland
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, Krasnodarskiy Kray, 350020, Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow, 107076, Russia
Russian state medical-stomatological university n.a. Evdokimov
Moscow, 111398, Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, 194021, Russia
LLC ArsVitae NorthWest
Saint Petersburg, 194223, Russia
LLC Medical Center "Kurator"
Saint Petersburg, 196240, Russia
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Gachon University Gil Medical Center
Incheon, Korea, 21565, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 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, Canton of Vaud, 1011, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
HUG-Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.), Taiwan, 33342, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei, 10508, Taiwan
Related Publications (6)
Thyssen JP, Werfel T, Barbarot S, Hunter HJA, Pierce E, Sun L, Cirri L, Buchanan AS, Lu N, Wollenberg A. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023 Dec;34(1):2190430. doi: 10.1080/09546634.2023.2190430.
PMID: 36912484DERIVEDReich K, Simpson E, Wollenberg A, Bissonnette R, Abe M, Cardillo T, Janes J, Sun L, Chen S, Silverberg JI. Efficacy of downtitration or treatment withdrawal compared with continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomized substudy from the long-term extension study BREEZE-AD3. Br J Dermatol. 2023 Feb 10;188(2):208-217. doi: 10.1093/bjd/ljac057.
PMID: 36763879DERIVEDWollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.
PMID: 36749121DERIVEDKatoh 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.
PMID: 36255569DERIVEDSilverberg 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.
PMID: 33978711DERIVEDKing 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.
PMID: 33826132DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 7, 2017
Study Start
March 28, 2018
Primary Completion
September 21, 2020
Study Completion
July 12, 2023
Last Updated
September 3, 2024
Results First Posted
July 1, 2022
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
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.