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NCT07107659 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Efficacy of ONT01 in Lupus
A Early Phase 1 study of Systemic Lupus Erythematosus and Lupus, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT07107659 is a Early Phase 1 study of Systemic Lupus Erythematosus and Lupus that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 61 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07107659, a Early Phase 1 study of Systemic Lupus Erythematosus and Lupus, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DRUG ONT01 is a small molecule CD11b modulator.
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| 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, categorized as Early Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (84% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
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.
NCT07107659 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
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.
What interventions are being tested in trial NCT07107659?
The interventions under investigation include: ONT01 is a small molecule CD11b modulator. (DRUG).
Who is sponsoring clinical trial NCT07107659?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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.
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