Actively Recruiting
Safety and Efficacy of ONT01 in Lupus Nephritis and Systemic Lupus Erythematosus
Led by Hospital for Special Surgery, New York · Updated on 2025-11-20
61
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
T
The University of Texas Medical Branch, Galveston
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying ONT01, a drug being evaluated for its safety and tolerability in people with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE). The study aims to see how ONT01, when combined with common lupus treatments like mycophenolate mofetil, affects lupus symptoms. This early phase 1 study will enroll 61 participants to better understand ONT01's effects in these conditions. Participants will take ONT01 orally twice daily, about 12 hours apart, under fasting conditions with water. The tablets must be swallowed whole. The study focuses on patients with active non-renal SLE or active LN, including specific lupus nephritis classifications confirmed by kidney biopsy and urine protein measurements. The treatment period and dosing schedule are designed to assess safety and biological effects. During the study, participants will be monitored from enrollment until 18 weeks for adverse events and study completion or withdrawal. Researchers will also measure lupus and nephritis biomarkers up to day 28 to evaluate biological response. Participants will undergo clinical assessments and laboratory tests, including kidney function and protein levels in urine, to track the treatment's impact. Safety and tolerability are key outcomes throughout the study duration.
CONDITIONS
Brief Title
Safety and Efficacy of ONT01 in Lupus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older and able to provide informed consent
- Diagnosis of Systemic Lupus Erythematosus (SLE) meeting ACR classification criteria
- Active non-renal SLE with at least one active non-renal clinical manifestation and failure of at least one disease modifying anti-rheumatic drug (DMARD) therapy (excluding hydroxychloroquine and corticosteroids)
- Active lupus nephritis confirmed by kidney biopsy within 1 year and specific urine protein/creatinine ratio thresholds
- Female patients of childbearing potential must agree to use highly effective contraception during the study and for at least 120 days after last study drug exposure; male patients with partners of childbearing potential must use barrier contraception during the study and for 120 days after last study drug exposure
- No sperm or egg donation during the study and 120 days after last study drug exposure
You will not qualify if you...
- Any uncontrolled disease or condition posing inappropriate risk or interfering with study participation
- Active central nervous system SLE with significant cognitive impairment preventing consent or protocol compliance
- Comorbidities requiring systemic corticosteroid therapy (oral, rectal, or injectable), excluding stable dosing by other routes
- Active significant infections or recent major infection requiring hospitalization or parenteral treatment
- Positive tests for HIV, hepatitis B or C at screening
- Active or untreated latent tuberculosis
- History of malignancy within 10 years except certain treated skin or cervical conditions
- Immunization with live vaccines within 1 month before or during screening
- Recent changes in angiotensin-converting enzyme inhibitor or angiotensin receptor blocker dosing
- Treatment with Voclosporin, Cyclophosphamide, or other investigational agents within defined washout periods
- Significant laboratory abnormalities not due to active SLE
- Significant chest imaging abnormalities or active tuberculosis evidence
- Pregnant or breastfeeding women
- Inability or unwillingness to follow contraception requirements if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive ONT01 orally twice daily under fasted conditions to treat Lupus Nephritis or Systemic Lupus Erythematosus.
Weekly visits for up to 18 weeks
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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