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Looking for participantsPhase2

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

Sponsor: Boehringer Ingelheim

NCT ID: NCT07409181

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BI 3000202 (drug), Placebo (drug)
How long the study runs
Study runs about 39 months (dates as stated)
About the drug or intervention
BI 3000202 — drug: BI 3000202 at different doses · Placebo — drug: Placebo matching BI 3000202
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 74 Years
Who
All
Number of participants
405
Started
2026-04-20
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus
  • • Phase2 - 405 participants
  • • This study is open to adults with systemic lupus erythematosus (SLE)

Who can take part?

  • • Ages 18 Years to 74 Years
  • • Diagnosed with systemic lupus erythematosus

Where?

  • • Basingstoke - Basingstoke and North Hampshire Hospital
  • • Belfast - Belfast City Hospital
  • • Cambridge - Addenbrooke's Hospital
  • • Doncaster - Doncaster Royal Infirmary
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Systemic Lupus Erythematosus

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 74 Years
  • Who can join: All genders

Biomarkers mentioned

following positive

What the study is looking for

  • ✓Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
  • ✓At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded...
  • ✓\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K...
  • ✓At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient...

Who cannot take part

  • ✗Drug-induced SLE
  • ✗Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.
See the full 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.

Where Is This Study? (5 UK sites)

Basingstoke and North Hampshire Hospital

Basingstoke RG24 9NA, United Kingdom

Recruiting
Site contact (verified)

Belfast City Hospital

Belfast BT9 7AB, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Doncaster Royal Infirmary

Doncaster DN2 5LTT, United Kingdom

Recruiting
Site contact (verified)

Guy's Hospital

London SE1 9RT, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09