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NCT06581562 · ClinicalTrials.gov registry record · Phase 1
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
A Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by IRIS Research and Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06581562 is a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that is actively recruiting participants, run by IRIS Research and Development. The registered enrollment target is 30 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06581562, a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by IRIS Research and Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG AB-101
Study Locations (1)
Florida
- IRIS Research and Development, LLC - Plantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06581562
The ClinicalTrials.gov registry entry for NCT06581562 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is IRIS Research and Development, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06581562 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06581562 about?
NCT06581562 is a clinical study titled "Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.". This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA)...
What is the current status of trial NCT06581562?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-15. Estimated completion is 2028-12.
What conditions does trial NCT06581562 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Granulomatosis With Polyangiitis, Pemphigus Vulgaris.
What interventions are being tested in trial NCT06581562?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), AB-101 (DRUG).
Who is sponsoring clinical trial NCT06581562?
This trial is sponsored by IRIS Research and Development, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06581562 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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