A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis

NCT03733301 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 17100I4V-MC-JAIY2018-001726-26
• Study Type: interventional
• Target: 329
• Locations: 9 countries
• Sites: 67

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

eczema; atopic eczema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement

  The IGA measures investigators 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) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

  Week 16

Secondary Outcomes (24)

• Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

  Week 16

• Percentage of Participants Achieving EASI90

  Week 16

• Percent Change From Baseline on EASI Score

  Baseline, Week 16

• Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

  Week 16

• Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)

  Week 16

Study Arms (3)

4 Milligram (mg) Baricitinib

EXPERIMENTAL

4 mg Baricitinib administered orally once daily in combination with topical corticosteroids (TCS). Placebo administered orally once daily to match 2 mg Baricitinib.

Drug: Baricitinib; Drug: Topical corticosteroid; Drug: Placebo

2 mg Baricitinib

EXPERIMENTAL

2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.

Drug: Baricitinib; Drug: Topical corticosteroid; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo administered orally once daily in combination with TCS.

Drug: Topical corticosteroid; Drug: Placebo

Interventions

Baricitinib DRUG

Administered orally.

Also known as: LY3009104

2 mg Baricitinib; 4 Milligram (mg) Baricitinib

Topical corticosteroid DRUG

Administered as standard-of-care.

2 mg Baricitinib; 4 Milligram (mg) Baricitinib; Placebo

Placebo DRUG

Administered orally.

2 mg Baricitinib; 4 Milligram (mg) Baricitinib; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months.
• Have had inadequate response 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.

You may not qualify if:

• 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 episodes 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 less than 4 weeks prior to randomization.
• Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection 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 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Incyte Corporation: collaborator

Study Sites (68)

Centro de Investigaciones Metabólicas (CINME) - Comite

Ciudad Autonoma Buenos Aires, C1056ABJ, Argentina

Location

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, C1121ABE, Argentina

Location

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, C1425BEA, Argentina

Location

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, C1425DKG, Argentina

Location

Parra Dermatología

Mendoza, 5500, Argentina

Location

Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

Location

Skin & Cancer Foundation Australia

Westmead, New South Wales, 2145, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Clinical Trials SA Pty Ltd

Adelaide, South Australia, 5073, Australia

Location

Skin and Cancer Foundation Inc.

Melbourne, Victoria, 3053, Australia

Location

Fremantle Dermatology

Perth, Western Australia, 6160, Australia

Location

Universitätsklinikum Graz

Graz, Styria, 8036, Austria

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum der Universität München

München, Bavaria, 80337, Germany

Location

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

Darmstadt, Hesse, 64283, Germany

Location

Dermatologisches Zentrum Osnabrück Nord

Bramsche, Lower Saxony, 49565, Germany

Location

Universitätsklinikum Aachen - UKA

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20537, Germany

Location

Policlinico Univ. Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

Genova, 16132, Italy

Location

Azienda Ospedaliera - Universitaria Pisana

Pisa, 56126, Italy

Location

ULSS 8 UOC Dermatologia Viale Rodolfi, 37

Vicenza, 36100, Italy

Location

Kawashima Dermatology Clinic

Ichikawa-shi, Chiba, 272-0033, Japan

Location

Medical Corporation Soleil Miyata Dermatology Clinic

Matsudo-shi, Chiba, 271-0092, Japan

Location

Yamano Dermatological Clinic

Dazaifu, Fukuoka, 818-0104, Japan

Location

Tashiro Dermatological Clinic

Iizuka, Fukuoka, 820-0040, Japan

Location

Shibaki Dermatology Clinic

Sapporo, Hokkaido, 006 0022, Japan

Location

Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Queen's Square Dermatology and Allergology

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

Location

Yoshioka Dermatology Clinic

Neyagawa, Osaka, 572-0838, Japan

Location

Senri-Chuo Hanafusa Dermatology Clinic

Toyonaka-shi, Osaka, 560-0085, Japan

Location

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu, Shizuoka, 430-0929, Japan

Location

Iidabashi Clinic

Chiyoda-ku, Tokyo, 102-0072, Japan

Location

Tokyo Teishin Hospital

Chiyoda-Ku, Tokyo, 102-8798, Japan

Location

Hosono Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Oizumi Hanawa Clinic

Nerima-ku, Tokyo, 178-0063, Japan

Location

Yamate Dermatological Clinic

Shinjuku, Tokyo, 169-0075, Japan

Location

Tachikawa Dermatology Clinic

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Shirasaki Clinic

Takaoka-shi, Toyama, 9330871, Japan

Location

Dermed Centrum Medyczne Sp. z o.o.

Lodz, 90-265, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

Centrum Medyczne AMED

Warsaw, 01-518, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Gachon University Gil Medical Center

Incheon, Korea, 21565, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Konkuk University Hospital

Seoul, 05030, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Chungang University Hospital

Seoul, 06973, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Hospital De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 83301, Taiwan

Location

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Chang Gung Memorial Hospital - Taipei

Taipei, 10508, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan, (r.o.c.), 333, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 36749121 DERIVED

• 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.

  PMID: 36255569 DERIVED

• Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.

  PMID: 34275122 DERIVED

• Buhl T, Rosmarin D, Serra-Baldrich E, Fernandez-Penas P, Igarashi A, Konstantinou MP, Chen S, Lu N, Pierce E, Casillas M. Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies. Dermatol Ther (Heidelb). 2021 Jun;11(3):971-982. doi: 10.1007/s13555-021-00534-8. Epub 2021 Apr 25.

  PMID: 33899152 DERIVED

• 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.

  PMID: 33826132 DERIVED

• Reich K, Kabashima K, Peris K, Silverberg JI, Eichenfield LF, Bieber T, Kaszuba A, Kolodsick J, Yang FE, Gamalo M, Brinker DR, DeLozier AM, Janes JM, Nunes FP, Thyssen JP, Simpson EL. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1333-1343. doi: 10.1001/jamadermatol.2020.3260.

  PMID: 33001140 DERIVED

Related Links

• A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

baricitinib; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

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: October 30, 2018
• First Posted: November 7, 2018
• Study Start: November 16, 2018
• Primary Completion: July 29, 2019
• Study Completion: August 22, 2019
• Last Updated: August 11, 2020
• Results First Posted: August 11, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AU (7); AR (5); DE (10); JP (17); PL (4); IT (5); KR (8); ES (5); TW (6)