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A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT06570798 · View on ClinicalTrials.gov ↗
Study Summary
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).
Conditions Studied
Interventions
- DRUG Inebilizumab
- DRUG Blinatumomab
Study Locations (20)
Florida
- Vida Research Center — Hialeah
- Homestead Associates In Research Inc — Homestead
- Vitaly Clinical Research — Miami
- Bioresearch Partner Coral Terrace — South Miami
New York
- Northwell Health — Great Neck
- Westchester Medical Center — Hawthorne
- Columbia University Medical Center — New York
- University of Rochester Medical Center — Rochester
Ohio
- MetroHealth Medical Center — Cleveland
- Cleveland Clinic Foundation — Cleveland
Other
- Cliniques Universtaire Saint Luc Universite Catholique de Louvain — Brussels
- Universitair Ziekenhuis Gent — Ghent
Arizona
- HonorHealth Research and Innovation Institute — Scottsdale
Colorado
- University of Colorado — Aurora
Louisiana
- University Medical Center New Orleans — New Orleans
Massachusetts
- Massachusetts General Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2029-03-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06570798
The ClinicalTrials.gov registry entry for NCT06570798 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions — of which Inebilizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06570798 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06570798 about?
NCT06570798 is a clinical study titled "A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases". The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active...
What is the current status of trial NCT06570798?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2025-07-16. Estimated completion is 2029-03-09.
What conditions does trial NCT06570798 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06570798?
The interventions under investigation include: Inebilizumab (DRUG), Blinatumomab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06570798?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06570798 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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