RecruitingPhase 2interventionalRules rewrite

Phase 2: testing BI 3000202 for Systemic Lupus Erythematosus

This study is open to adults with systemic lupus erythematosus (SLE). this study wants to find out whether a medicine called BI 3000202 helps people with SLE.

Official registry: https://clinicaltrials.gov/study/NCT07409181 · Boehringer Ingelheim · enrollment listed as 405

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BI 3000202, or Placebo. The registry lists allocation as randomized. This study is open to adults with systemic lupus erythematosus (SLE).

They plan to enroll about 405 people at 139 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: BI 3000202, Placebo

Primary outcome (registry wording): Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response

Who it is for (from inclusion criteria)

Ages 18 Years to 74 Years
Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
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
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
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

Who the registry excludes

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
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)
Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further

Public study contact (from the registry)

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

139 listed

Wallace & Lee Center — Beverly Hills, California (not_yet_recruiting)
Arthritis & Osteoporosis Medical Center, Inc - La Palma — La Palma, California (recruiting)
University of California San Diego — San Diego, California (not_yet_recruiting)
University of California Los Angeles — Torrance, California (recruiting)
Inland Rheumatology Clinical Trials, Inc — Upland, California (recruiting)
Focus Clinical Research — West Hills, California (recruiting)
Denver Arthritis Clinic - Lowry — Denver, Colorado (not_yet_recruiting)
AARDS Research, Inc. — Aventura, Florida (recruiting)
Meris Clinical Research-Brandon-69466 — Brandon, Florida (not_yet_recruiting)
Clinical Research of West Florida, Inc. — Clearwater, Florida (not_yet_recruiting)
Integral Rheumatology and Immunology Specialist — Plantation, Florida (not_yet_recruiting)
Clinical Research of West Florida, Inc. - Tampa — Tampa, Florida (recruiting)

+ 109 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07409181 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07409181?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07409181?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary