A study to test whether different doses of BI 3000202 help people with systemic lupus erythematosus (SLE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523488-39-00

WHO UTN

U1111-1329-5843

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

The primary objectives are to demonstrate a non-flat dose response curve and to evaluate the treatment effect of different dose regimens of BI 3000202 vs. placebo based on the primary endpoint of achievement of SRI-4 response at Week 32 in patients with moderate to severe SLE.

Secondary objectives 1

1. The secondary objectives are to evaluate the size of the treatment effect based on the secondary endpoints of achievement of SRI-4 response at Week 52, achievement of SRI-4 response with oral corticosteroid to ≤5 mg/day prednisone or equivalent at Week 32, and achievement of LLDAS at Week 32.

Conditions and MedDRA coding

Systemic lupus erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
2. 2. Confirmed SLE diagnosis meeting the EULAR/ACR classification criteria at least 24 weeks prior to screening
3. 3. At least one of the following positive at screening: antinuclear antibodies (ANA) ≥1:80 or anti-dsDNA antibody or anti-Smith antibody
4. 4. Total SLEDAI-2K score ≥6 points and clinical SLEDAI-2K score ≥4 points
5. 5. At least 1 BILAG A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
6. 6. 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)
7. Further inclusion criteria apply.

Exclusion criteria 6

1. 1. Drug-induced SLE
2. 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. 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. 4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or >2 × ULN and/or UPCR that is unstable or > 3mg/mg (339 mg/mmol)
5. 5. Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening
6. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32

Secondary endpoints 3

1. Achievement of SRI-4 response at Week 52
2. Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent at Week 32
3. Achievement of Lupus Low Disease Activity State (LLDAS) at Week 32

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 1

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

7 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 84 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications