臨床研究等提出・公開システム

Date of registration	April. 01, 2026
Last modified on	May. 13, 2026
Trial ID	jRCT2071250153

Scientific Title	Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)
Public Title	A study to test whether different doses of BI 3000202 help people with systemic lupus erythematosus (SLE)

Contact for Scientific Queries	Name	Ito Kenji
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com
Contact for Public Queries	Name	Katakabe Tetsuya
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-120-189-779
	E-mail	medchiken.jp@boehringer-ingelheim.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 30, 2026
Target sample size		405
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Male and female adult patients from >=18 years (or alternative age for adults based on local regulations) to <75 years 2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 24 weeks prior to screening 3. At least one of the following positive at screening: Antinuclear Antibodies (ANA) >=1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody etc. - Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 points and clinical SLEDAI-2K score >=4 points
	Exclusion Criteria	1. Drug-induced SLE 2. Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments 3. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy etc.
	Age Minimum	18age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Systemic lupus erythematosus
Intervention(s)		Drug: BI 3000202
Health Condition(s) Code		D008180
Primary Outcome(s)		Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32
Secondary Outcome(s)		Achievement of SRI-4 response at Week 52 Achievement of SRI-4 response and oral corticosteroid reduction to <=5 mg/day prednisone or equivalent at Week 32 Achievement of Lupus Low Disease Activity State (LLDAS) at Week 32

Primary Sponsor	Boehringer Ingelheim

Name of Certified Review Board	The IRB of Hospital of the University of Occupational and Environmental Health
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Fukuoka
Telephone	+81-93-691-7503
Approval Status	Approval
Date of approval	Mar. 11, 2026

Plan to share IPD	Yes
Plan description	Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

Secondary ID(s)	NCT07409181
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Argentina/Australia/Brazil/Bulgaria/China/Colombia/Croatia/Germany/Hungary/India/Mexico/Netherlands/Philippines/Poland/Romania/Serbia/South Africa/Spain/Taiwan/United Kingdom/United States

History of Changes

No	Publication date
2	May. 13, 2026	(this page)	Changes
1	April. 01, 2026	Detail

List of change history