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Study identifier: NCT07107659 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Safety and Efficacy of ONT01 in Lupus

Condition: Lupus Nephritis (LN) · Lupus Nephritis - WHO Class III · Lupus Nephritis - WHO Class IV  ·  Sponsor: Hospital for Special Surgery, New York

PhaseEARLY_Phase 1
Planned participants61
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (1)

Hospital for Special SurgeryNew York, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07107659