Safety and Efficacy of ONT01 in Lupus
NCT07107659
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- 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)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Early Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Hospital for Special Surgery, New York
- Last updated on ClinicalTrials.gov
- November 20, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New York · 1
- Hospital for Special Surgery · New York, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.