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Phase 2RecruitingInterventionalNCT07409181

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

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)

  • Systemic Lupus Erythematosus
I want to take partRefer a patient4 sites in India · 141 worldwide

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
405
Started
20 April 2026
Main results due (estimated)
4 February 2029
Study ends (estimated)
8 July 2029
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
141 · 4 in India
First posted
13 February 2026
Registry updated
1 October 2026

Can you take part?

  • Ages 18 years to 74 years.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility 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

   \- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points
4. At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
5. On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.

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
4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \>2 × Upper Limit of Normal (ULN) and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or \> 3mg/mg (339 mg/mmol)
5. Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.

What this study is about

In the sponsor’s own words, from the registry.

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.

Keywords: Lupus

What participants receive

  • Experimental

    Arm 1: BI 3000202 dose 1

    Drug: BI 3000202

  • Experimental

    Arm 2: BI 3000202 dose 2

    Drug: BI 3000202

  • Experimental

    Arm 3: BI 3000202 dose 3

    Drug: BI 3000202

  • Experimental

    Arm 4: BI 3000202 dose 4

    Drug: BI 3000202

  • Placebo comparator

    Arm 5: Placebo

    Drug: Placebo

Interventions

  • BI 3000202Drug

    BI 3000202 at different doses

  • PlaceboDrug

    Placebo matching BI 3000202

What the study measures

Primary outcomes

  1. Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response

    Time frame: At Week 32

Secondary outcomes

  1. Achievement of SRI-4 response

    Time frame: At Week 52

  2. Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent

    Time frame: At Week 32

  3. Achievement of Lupus Low Disease Activity State (LLDAS)

    Time frame: At Week 32

Who is running it

Lead sponsor
Boehringer Ingelheim
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Boehringer Ingelheim
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
1509-0004
Other IDs
2025-523488-39-00, U1111-1329-5843, 2025

Study sites(141)

Showing 40 of 141 sites, filter to narrow it down. 79 of 141 on this study are recruiting right now, and 4 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Yes
What is shared
Study protocol, Sap, Csr
When
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access
For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Source: ClinicalTrials.gov record NCT07409181, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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