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Clinical Trials List

Protocol NumberI4V-MC-JAHN

NCT Number(ClinicalTrials.gov Identfier)NCT03334435

2018-03-01 - 2021-06-30

Phase III

Terminated6

ICD-10L20.9

Atopic dermatitis, unspecified

ICD-10L20

Atopic dermatitis

A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor

Eli Lilly and Company
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator TSEN-FANG TSAI Division of Dermatology

National Taiwan University Hospital

Co-Principal Investigator

Chia-Yu Chu Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator 賴柏如 Division of Dermatology

Chung Shan Medical University Hospital

Co-Principal Investigator

王鼎舜 Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 何宜承 Division of Dermatology

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

鄭裕文 Division of Dermatology
林尚宏 Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Woan-Ruoh Lee Division of Dermatology

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

Chia-Lun Chou Division of Dermatology
Yi-Hsien Shih Division of Dermatology

The Actual Total Number of Participants Enrolled

5 Stop recruiting

Audit

CRO

Principal Investigator

Linkou Chang Gung Medical Foundation

Taiwan National PI

Wen-Hung Chung

Co-Principal Investigator

Yu-Huei Huang Division of Dermatology
Chung-Yao Hsu Division of Dermatology
Chin-Yi Yang Division of Pediatrics
I-Hsin Shih Division of Pediatrics
Ya-Ching Chang Division of Dermatology
Wen-Hung Chung Division of Dermatology
Ng Chau Yee Division of Dermatology

The Actual Total Number of Participants Enrolled

6 Stop recruiting

Audit

None

Principal Investigator Chao-Chun Yang Division of Dermatology

National Taiwan University Hospital

Co-Principal Investigator

Chao-Kai Hsu Division of Dermatology
Tak-Wah Wong Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Condition/Disease

Atopic Dermatitis

Objectives

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

Test Drug

Baricitinib (LY3009104)

Active Ingredient

Baricitinib (LY3009104)

Dosage Form

Tablet

Dosage

1 mg / 2 mg / 4 mg

Endpoints

Primary Outcome Measures:
1. Proportion of Participants with a Response of Investigator's Global Assessment (IGA) 0 or 1 at 16 Week.
2. Proportion of Participants with a Response of IGA 0 or 1 at 36 Weeks.
3. Proportion of Participants with a Response of IGA 0 or 1 at 52 Weeks.

Secondary Outcome Measures:
1. Proportion of Participants Achieving IGA 0, 1 or 2.
2. Proportion of Participants Achieving IGA 0 or 1 (non-responders).
3. Proportion of Participants Achieving Response of Eczema Area and Severity Index (EASI)75 from Baseline of Originating Study.
4. Proportion of Participants with a 4-Point Improvement from Baseline of Originating Study in Itch NRS.

Inclution Criteria

1. Have completed the final active treatment visit for an originating study eligible to enroll participants directly into study BREEZE-AD3 OR
2. Meet criteria for NCT03334396 or NCT03334422.

Exclusion Criteria

1. Had investigational product permanently discontinued at any time during a previous baricitinib study.
2. 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.

The Estimated Number of Participants

Taiwan

120 participants
Global

1760 participants