๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-19

Safety and Efficacy of ONT01 in Lupus (NCT07107659)

Safety and Efficacy of ONTO1 in Lupus

๐ŸŸข Recruiting Early Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Hospital for Special Surgery, New York

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Hospital for Special Surgery โ€” New York, New York

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Hospital for Special Surgery โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (646) 797-8698

Email: felixc@hss.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—