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RECRUITING Early Phase 1

Safety and Efficacy of ONT01 in Lupus

NCT07107659 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG ONT01 is a small molecule CD11b modulator.

Study Locations (1)

New York

  • Hospital for Special Surgery — New York

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2026-09-04
Est. Completion 2030-05
Phase Early Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07107659

The ClinicalTrials.gov registry entry for NCT07107659 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention — of which ONT01 is a small molecule CD11b modulator. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07107659 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07107659 about?

NCT07107659 is a clinical study titled "Safety and Efficacy of ONT01 in Lupus". 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 h...

What is the current status of trial NCT07107659?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 61 participants. The study started on 2026-09-04. Estimated completion is 2030-05.

What conditions does trial NCT07107659 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus, SLE, Lupus Nephritis (LN), Lupus Nephritis - WHO Class IV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07107659?

The interventions under investigation include: ONT01 is a small molecule CD11b modulator. (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07107659?

This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07107659 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial