A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

ClinicalTrials.gov ID: NCT07409181

Public ClinicalTrials.gov record NCT07409181. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 9:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.

Study identification

NCT ID: NCT07409181
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 405 participants

Conditions and interventions

Conditions

Systemic Lupus Erythematosus

Interventions

BI 3000202 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 74 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 19, 2026
Primary completion: Feb 3, 2029
Completion: Jul 7, 2029
Last update posted: Sep 7, 2026

2026 – 2029

United States locations

U.S. sites: 30
U.S. states: 12
U.S. cities: 30

Facility	City	State	ZIP	Site status
Wallace & Lee Center	Beverly Hills	California	90210	Not yet recruiting
Arthritis & Osteoporosis Medical Center, Inc - La Palma	La Palma	California	90623	Not yet recruiting
University of California San Diego	San Diego	California	92037	Not yet recruiting
University of California Los Angeles	Torrance	California	90509	Not yet recruiting
Inland Rheumatology Clinical Trials, Inc	Upland	California	91786	Recruiting
Focus Clinical Research	West Hills	California	91307	Recruiting
Denver Arthritis Clinic - Lowry	Denver	Colorado	80230	Not yet recruiting
AARDS Research, Inc.	Aventura	Florida	33180	Recruiting
Meris Clinical Research-Brandon-69466	Brandon	Florida	33511	Not yet recruiting
Clinical Research of West Florida, Inc.	Clearwater	Florida	33763	Not yet recruiting
Integral Rheumatology and Immunology Specialist	Plantation	Florida	33324	Not yet recruiting
Clinical Research of West Florida, Inc. - Tampa	Tampa	Florida	33606	Recruiting
AA MRC LLC - Grand Blanc	Grand Blanc	Michigan	48439	Not yet recruiting
June DO, PC	Lansing	Michigan	48911	Not yet recruiting
Oscar Clinical Trials	Jackson	Mississippi	39206	Recruiting
Boeson Research - Great Falls	Great Falls	Montana	59405	Recruiting
DJL Clinical Research, PLLC	Charlotte	North Carolina	28211	Not yet recruiting
Cross Creek Medical Clinic, PA	Fayetteville	North Carolina	28304	Not yet recruiting
Paramount Medical Research and Consulting	Middleburg Heights	Ohio	44130	Recruiting
Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	73104	Not yet recruiting
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research	Duncansville	Pennsylvania	16635	Recruiting
West Tennessee Research Institute	Jackson	Tennessee	38305	Not yet recruiting
Shelby Research LLC	Memphis	Tennessee	38119	Recruiting
Arthritis & Rheumatology Institute - Allen	Allen	Texas	75013	Not yet recruiting
Amarillo Center for Clinical Research	Amarillo	Texas	79124	Recruiting
Precision Comprehensive Clinical Research Solutions - Colleyville	Colleyville	Texas	76034	Not yet recruiting
Precision Comprehensive Clinical Research Solutions	Euless	Texas	76040	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	77030	Not yet recruiting
R&H Clinical Research - Katy	Katy	Texas	77449	Recruiting
SouthWest Rheumatology Research	Mesquite	Texas	75150	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 110 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07409181, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 7, 2026 · Synced Sep 10, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07409181 live on ClinicalTrials.gov.

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