Trials / Recruiting
RecruitingNCT07107659
Safety and Efficacy of ONT01 in Lupus
Safety and Efficacy of ONTO1 in Lupus
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- 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)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONT01 is a small molecule CD11b modulator. | ONT01 will be administered orally twice daily (in the morning and in the evening at approximately 12 hours apart and approximately the same time each day) and should be taken as whole tablets (not crushed) under fasted conditions (2 hours before and 1 hour after each dose) with 8 oz/240 mL of water. |
Timeline
- Start date
- 2026-09-04
- Primary completion
- 2030-05-01
- Completion
- 2030-05-01
- First posted
- 2025-08-06
- Last updated
- 2025-11-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07107659. Inclusion in this directory is not an endorsement.