Clinical Trial

Safety and Efficacy of ONT01 in Lupus

Recruiting Early Phase 1
View on ClinicalTrials.gov →
Summary
ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-04; most recent amendment 2025-11-19.
Status change: Not Yet Recruiting → Recruiting 2025-11-19
Trial Details
NCT Number NCT07107659
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: The University of Texas Medical Branch, Galveston
Conditions Lupus Nephritis (LN), Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Lupus Nephritis - World Health Organization (WHO) Class III, Lupus, SLE, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (Disorder)
Enrollment 61 participants
Start Date 2026-09-04
Primary Completion 2030-05 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-20