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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: Recruiting Early Phase 1 study of Systemic Lupus Erythematosus and Lupus, sponsored by Hospital for Special Surgery, New York.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This pilot phase 1 study will establish the highest safe dose of ONT01 and help generate preliminary evidence in support of future, large-scale, multi-site, controlled Phase 2 efficacy clinical trials with ONT01 in lupus, so that it can be developed as a novel, myeloid directed, oral therapeutic for lupus.
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 |
What NCT07107659 shows while recruiting
NCT07107659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT07107659's enrollment target sits among peer trials
61 69th of 99 higher than 31 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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