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

NCT ID: NCT03334435

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1645 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2023-07-12

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Responders and Partial Responders (RPR)-Placebo

Responders 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.

Group Type: PLACEBO_COMPARATOR

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

RPR-Bari 1-milligram (mg)

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

RPR-Bari 2-mg

RPR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

RPR-Bari 4-mg

RPR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Non-responders (NR): Bari 1 mg to 2 mg

Non-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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

NR: Bari 1 mg to 4 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

NR: Bari 2 mg to 2 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

NR: Bari 2 mg to 4 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

NR: Bari 4 mg to 4 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

NR: Placebo to Bari 2 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

NR: Placebo to Bari 4 mg

NR 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Placebo

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Bari 1 mg

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Bari 2 mg

Participants 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Bari 4 mg

Participants 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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Bari 2-mg Open-Label Addendum

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Interventions

Baricitinib

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3009104

Eligibility 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

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, , Argentina

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, , Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, , Argentina

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, , Argentina

Parra Dermatología

Mendoza, , Argentina

Woden Dermatology

Phillip, Australian Capital Territory, Australia

Skin & Cancer Foundation Australia

Westmead, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Clinical Trials SA Pty Ltd

Adelaide, South Australia, Australia

Skin and Cancer Foundation Inc.

Carlton, Victoria, Australia

Fremantle Dermatology

Perth, Western Australia, Australia

Universitätsklinikum Graz

Graz, Styria, Austria

Ordensklinikum Linz GmbH - Elisabethinen

Linz, Upper Austria, Austria

KA Rudolfstiftung

Vienna, , Austria

AKH

Vienna, , Austria

KH Hietzing mit neurologischem Zentrum Rosenhügel

Vienna, , Austria

Sozialmed. Zentrum Ost - Donauspital

Vienna, , Austria

Kozni ambulance Kutna Hora, s.r.o.

Kutná Hora, Central Bohemia, Czechia

Clintrial, s.r.o.

Prague, Hl. M. Praha, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Hl. M. Praha, Czechia

Fakultni Nemocnice v Motole

Prague, Hl. M. Praha, Czechia

Nemocnice Na Bulovce

Prague, Hl. M. Praha, Czechia

Nemocnice Novy Jicin a.s.

Nový Jičín, Moravskoslezský kraj, Czechia

Fakultni Nemocnice Plzen

Plzen-Bory, Plzeň Region, Czechia

Fakultni Nemocnice U svate Anny

Brno, South Moravian, Czechia

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

Ústí nad Labem, Ustecký Kraj, Czechia

Gentofte Hospital

Hellerup, Capital Region, Denmark

Aarhus Universitehospital Marselisborg Centret

Aarhus, Region Midtjyland, Denmark

Hopital Saint-Louis

Paris, Cedex 10, France

CHU de Bordeaux Hopital Saint Andre

Bordeaux, , France

CHU Grenoble Alpes

Grenoble Cédex 9, , France

Chru De Nantes Hotel-Dieu

Nantes, , France

CHU de Nice Hopital de L'Archet

Nice, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Hopital Larrey

Toulouse, , France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum der Universität München

München, Bavaria, Germany

Gemeinschaftspraxis Mahlow

Blankenfelde-Mahlow, Brandenburg, Germany

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

Darmstadt, Hesse, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Dermatologisches Zentrum Osnabrück Nord

Bramsche, Lower Saxony, Germany

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Praxis Gerlach

Dresden, Saxony, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Universität Leipzig - Universitätsklinikum

Leipzig, Saxony, Germany

Universitätsklinikum Otto-von-Guericke-Universität

Magdeburg, Saxony-Anhalt, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik

Aachen, , Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

Rothhaar Studien GmbH

Berlin, , Germany

ISA GmbH

Berlin, , Germany

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, , Germany

TFS Trial Form Support GmbH

Hamburg, , Germany

Oroshaza Varosi Onkormanyzat Korhaza

Orosháza, Bekes County, Hungary

SZTE AOK Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

Debrecen, Hajdú-Bihar, Hungary

Trial Pharma Kft.

Püspökladány, Hajdú-Bihar, Hungary

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, Hungary

Kaposi Mor Oktato Korhaz

Kaposvár, Somogy County, Hungary

Markusovszky Korhaz

Szombathely, Vas County, Hungary

UNO Medical Trials Kft.

Budapest, , Hungary

MedMare Bt

Veszprém, , Hungary

King George Hospital

Vizag, Andhra Pradesh, India

Panchshil Hospital

Ahmedabad, Gujarat, India

Byramjee Jeejeebhoy Medical College & Civil Hospital

Ahmedabad, Gujarat, India

Dr. D. Y. Patil Medical College & Hospital

Navi Mumbai, Maharashtra, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharshtra, India

All India Institue of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Gandhi Hospital

Secunderabad, Telangana, India

Haemek Medical Center- Dermatology

Afula, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Policlinico Univ. Agostino Gemelli

Rome, Lazio, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

Genova, , Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Azienda Ospedaliera - Universitaria Pisana

Pisa, , Italy

Policlinico di Tor Vergata

Roma, , Italy

Ospedale Policlinico Giambattista Rossi, Borgo Roma

Verona, , Italy

ULSS 8

Vicenza, , Italy

Yanagihara dermatology clinic

Ainokawa, Ichikawa-shi, Chiba, Japan

Kawashima Dermatology Clinic

Ichikawa-shi, Chiba, Japan

Medical Corporation Soleil Miyata Dermatology Clinic

Matsudo-shi, Chiba, Japan

Fumimori Clinic

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Shibaki Dermatology Clinic

Sapporo, Hokkaido, Japan

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

Queen's Square Dermatology and Allergology

Nishi-ku, Yokohama-city, Kanagawa, Japan

Nomura Dermatology Clinic

Yokohama, Kanagawa, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Noguchi Dermatology

Kashima-machi, Kamimashiki-gun, Kumamoto, Japan

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Osaka Habikino Medical Center

Habikino, Osaka, Japan

Yoshioka Dermatology Clinic

Neyagawa, Osaka, Japan

Kume Clinic

Nishi-ku Sakai-shi, Osaka, Japan

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka-shi, Osaka, Japan

Sanrui Dermatology Clinic

Ohmiya-ku,Saitama-shi, Saitama, Japan

Shimane University Hospital

Izumo, Shimane, Japan

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Iidabashi Clinic

Chiyoda-ku, Tokyo, Japan

Tokyo Teishin Hospital

Chiyoda-Ku, Tokyo, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Hosono Clinic

Chuo-ku, Tokyo, Japan

Sumire Dermatology Clinic

Edogawa-ku, Tokyo, Japan

Oizumi Hanawa Clinic

Nerima-ku, Tokyo, Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-KU, Tokyo, Japan

Yamate Dermatological Clinic

Shinjuku, Tokyo, Japan

Tachikawa Dermatology Clinic

Tachikawa-shi, Tokyo, Japan

Shirasaki Clinic

Takaoka-shi, Toyama, Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Gifu University Hospital

Gifu, , Japan

Osaka City University Hospital

Osaka, , Japan

Grupo Medico Camino S.C.

Mexico City, Mexico City, Mexico

Hospital de Jesus I.A.P.

Mexico City, Mexico City, Mexico

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, Michoacan Morelia, Mexico

CRI Centro Regiomontano de Investigacion S.C.

Monterrey, Nuevo León, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

JM Research S.C.

Cuernavaca, , Mexico

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

Distrito Federal, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, , Mexico

DermoDent, Centrum Medyczne Czajkowscy

Osielsko, Kuyavian-Pomeranian Voivodeship, Poland

Barbara Rewerska DIAMOND CLINIC

Krakow, Lesser Poland Voivodeship, Poland

Lubelskie Centrum Diagnostyczne

Świdnik, Lublin Voivodeship, Poland

Centrum Medyczne AMED

Warsaw, Masovian Voivodeship, Poland

Centralny Szpital Kliniczny MSWiA

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, Poland

Wojskowy Instytut Medyczny CSK MON

Warsaw, Masovian Voivodeship, Poland

NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

Bialystok, Podlaskie Voivodeship, Poland

Centrum Badan Klinicznych, PI House

Gdansk, Pomeranian Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

Olsztyn, Warmian-Masurian Voivodeship, Poland

LASER CLINIC Specjalistyczne Gabinety Lekarskie

Szczecin, West Pomeranian Voivodeship, Poland

Dermed Centrum Medyczne Sp. z o.o.

Lodz, Łódź Voivodeship, Poland

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, Krasnodarskiy Kray, Russia

State scientific centre for dermatovenerology and cosmetolog

Moscow, , Russia

Russian state medical-stomatological university n.a. Evdokimov

Moscow, , Russia

SPb SBHI Skin-venerologic dispensary #10

Saint Petersburg, , Russia

LLC ArsVitae NorthWest

Saint Petersburg, , Russia

LLC Medical Center "Kurator"

Saint Petersburg, , Russia

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Korea, South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Chungang University Hospital

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Hospital Germans Trias i Pujol

Barcelona, Badalona, Spain

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Clinica Universitaria De Navarra

Pamplona, Navarre, Spain

Hospital General Universitario Alicante

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

Hospital Infanta Leonor

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Centro de Especialidades Mollabao

Pontevedra, , Spain

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Inselspital Bern

Bern, , Switzerland

HUG-Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Universitätsspital Zürich

Zurich, , Switzerland

Chang Gung Memorial Hospital - Linkou

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

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, , Taiwan

Taipei Medical University- Shuang Ho Hospital

New Taipei City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital - Taipei

Taipei, , Taiwan

Countries

Argentina; Australia; Austria; Czechia; Denmark; France; Germany; Hungary; India; Israel; Italy; Japan; Mexico; Poland; Russia; South Korea; Spain; Switzerland; Taiwan

References

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.

Reference Type: DERIVED

PMID: 36912484 (View on PubMed)

Reich 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.

Reference Type: DERIVED

PMID: 36763879 (View on PubMed)

Wollenberg 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.

Reference Type: DERIVED

PMID: 36749121 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36255569 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33978711 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33826132 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Original Protocol

View Document

Document Type: Study Protocol: Protocol Addendum

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/64kocErmNim2YSiiqCaOk6

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

Other Identifiers

I4V-MC-JAHN

Identifier Type: OTHER

Identifier Source: secondary_id

2017-000873-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16587

Identifier Type: -

Identifier Source: org_study_id