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Safety and Efficacy of ONT01 in Lupus

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  2. Start date: Sep 4, 2025 to Sep 4, 2026v3
  3. Start date: Aug 1, 2025 to Sep 4, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07107659
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: The University of Texas Medical Branch, Galveston
Conditions
(from sponsor)		 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)
Related terms Lupus Erythematosus, Systemic, Lupus Nephritis
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov