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NCT06570798 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
A Phase 2 study of Systemic Lupus Erythematosus and Active Refractory Rheumatoid Arthritis, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06570798 is a Phase 2 study of Systemic Lupus Erythematosus and Active Refractory Rheumatoid Arthritis that is actively recruiting participants, run by Amgen. The registered enrollment target is 220 participants, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06570798, a Phase 2 study of Systemic Lupus Erythematosus and Active Refractory Rheumatoid Arthritis, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (42% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06570798 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, Ohio.
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.
What interventions are being tested in trial NCT06570798?
The interventions under investigation include: Inebilizumab (DRUG), Blinatumomab (DRUG).
Who is sponsoring clinical trial NCT06570798?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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