Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
5
Countries
1
Sites
1
Granulomatous Polyangiitis
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
Key facts
- Sponsor
- Universitaet Leipzig
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 14 Nov 2025 → ongoing
- Decision date (initial)
- 2025-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
Secondary objectives 3
- Long term safety of blinatumomab as treatment regime in patients with SLE, SSc or GPA
- Evaluation of disease-related biomarkers such as: Anti ds-DNA antibodies in SLE, Pr3 antibodies in GPA, SCL-70 or RNAP III in diffuse cutaneous SSc
- Clinical efficacy
Conditions and MedDRA coding
Granulomatous Polyangiitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072580 | Granulomatous polyangiitis | 10047065 |
| 21.1 | LLT | 10025139 | Lupus erythematosus systemic | 10028395 |
| 28.0 | LLT | 10079544 | Systemic sclerosis sine scleroderma | 10028395 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- GENERAL INCLUSION CRITERIA: Age over 18 years
- SLE patients: Diagnosis of SLE according to EULAR/ ACR criteria for more than six months
- SLE patients: Serologically active disease: Positivity for ANA (1:160) and anti dsDNA, defined as more than ULN and Hypocomplementemia of C3 or C4
- SLE patients: Prior treatment failure of at least two immunosuppressive agents
- SLE patients: Clinical active disease: SLEDAI2k activity score > 6 and at least two BILAG B and/ or one BILAG A manifestation
- SSc patients: Diagnosis of dcSSc (2013 ACR/EULAR criteria for systemic sclerosis and LeRoy criteria for dcSSc)
- SSc patients: Disease onset from the first non-Raynaud symptoms within 6 years prior to screening visit.
- GPA patients: Diagnosis of GPA according to the Chapel Hill Consensus Conference definitions
- GPA patients: Positive serum Pr3-ANCA at screening or in medical history
- GPA patients: Active or refractory disease
Exclusion criteria 4
- Prior treatment with cellular immunotherapy (CAR T) or T cell engaging Antibodies
- History of allogeneic stem cell transplant
- Known infectious comorbidities (HIV positivity, Hepatitis B/C)
- Severely impaired cardiac function
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of treatment-emergent adverse events (adverse events up to week 12)
Secondary endpoints 3
- Incidence of treatment-emergent adverse events (adverse events from week 13 up to week 52)
- Reduction of Titers of significant autoantibodies such as anti-ds DNA antibodies, SCL-70 antibodies or Pr3 antibodies
- Clinical efficacy (Selena SLEDAI in SLE patients, ACR-CRISS score in cutaneous SSc patients, BVAS Score in GPA patients)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
PRD3418637 · Product
- Active substance
- Blinatumomab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 28 µg microgram(s)
- Max total dose
- 280 µg microgram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX07 — -
- Marketing authorisation
- EU/1/15/1047/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaet Leipzig
- Sponsor organisation
- Universitaet Leipzig
- Address
- Ritterstrasse 26, Zentrum Zentrum
- City
- Leipzig
- Postcode
- 04109
- Country
- Germany
Scientific contact point
- Organisation
- Universitaet Leipzig
- Contact name
- Susanne Melzer
Public contact point
- Organisation
- Universitaet Leipzig
- Contact name
- Susanne Melzer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 5 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-11-14 | 2025-11-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BlinA-B_trial protocol_p | 4 |
| Recruitment arrangements (for publication) | BlinA-B_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | BlinA-B_PIC data use_new | 2 |
| Subject information and informed consent form (for publication) | BlinA-B_PIC trial_new | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | BlinA-B_SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | BLINCYTO_SmPC_Jun 2025 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-09 | Germany | Acceptable 2025-09-24
|
2025-09-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-18 | Germany | Acceptable 2025-09-24
|
2025-11-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-20 | Germany | Acceptable 2026-03-17
|
2026-03-25 |