BLINATUMOMAB for Granulomatosis with polyangiitis | Systemic lupus erythematosus | Systemic sclerosis

Inclusion criteria

• {"criterion_text":"- GENERAL INCLUSION CRITERIA: Age over 18 years\n- GPA patients: Active or refractory disease\n- SLE patients: Diagnosis of SLE according to EULAR/ ACR criteria for more than six months\n- SLE patients: Serologically active disease: Positivity for ANA (1:160) and anti dsDNA, defined as more than ULN and Hypocomplementemia of C3 or C4\n- SLE patients: Prior treatment failure of at least two immunosuppressive agents\n- SLE patients: Clinical active disease: SLEDAI2k activity score > 6 and at least two BILAG B and/ or one BILAG A manifestation\n- SSc patients: Diagnosis of dcSSc (2013 ACR/EULAR criteria for systemic sclerosis and LeRoy criteria for dcSSc)\n- SSc patients: Disease onset from the first non-Raynaud symptoms within 6 years prior to screening visit.\n- GPA patients: Diagnosis of GPA according to the Chapel Hill Consensus Conference definitions\n- GPA patients: Positive serum Pr3-ANCA at screening or in medical history"}

Exclusion criteria

• {"criterion_text":"- Prior treatment with cellular immunotherapy (CAR T) or T cell engaging Antibodies\n- History of allogeneic stem cell transplant\n- Known infectious comorbidities (HIV positivity, Hepatitis B/C)\n- Severely impaired cardiac function"}

Primary endpoints

• {"endpoint_text":"- Incidence of treatment-emergent adverse events (adverse events up to week 12)","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events assessed up to week 12 (timeframe provided)."}

Secondary endpoints

• {"endpoint_text":"- Incidence of treatment-emergent adverse events (adverse events from week 13 up to week 52)","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events assessed from week 13 up to week 52 (timeframe provided)."}
• {"endpoint_text":"- Reduction of Titers of significant autoantibodies such as anti-ds DNA antibodies, SCL-70 antibodies or Pr3 antibodies","definition_or_measurement_approach":"Measurement of antibody titers (anti-dsDNA, SCL-70, Pr3) and their reduction over time."}
• {"endpoint_text":"- Clinical efficacy (Selena SLEDAI in SLE patients, ACR-CRISS score in cutaneous SSc patients, BVAS Score in GPA patients)","definition_or_measurement_approach":"Clinical efficacy assessed using disease-specific scores: Selena SLEDAI (SLE), ACR-CRISS (cutaneous SSc), BVAS (GPA)."}

Germany

Earliest CTIS Part Ii Submission Date

03-09-2025

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

203

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

Universitaet Leipzig

Organisation Type

Educational Institution

Country Of Registered Address

Germany