Actively Recruiting
Safety and Efficacy of ONT01 in Lupus
Led by Hospital for Special Surgery, New York · Updated on 2025-11-20
61
Participants Needed
1
Research Sites
190 weeks
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
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
Official 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 symptom and failure of at least one disease modifying anti-rheumatic drug (DMARD) therapy (excluding hydroxychloroquine and corticosteroids)
- Active lupus nephritis (LN) with kidney biopsy showing Class III, IV, V, III+V, or IV+V within 1 year of screening
- 24-hour urine protein/creatinine ratio of 1 g/g or greater at screening
- No partial renal response after at least 3 months of induction and maintenance therapy with mycophenolate mofetil and other standard treatments
- Female participants of childbearing potential must agree to use highly effective contraception during the study and for at least 120 days after last exposure to study drug
- Male participants with female partners of childbearing potential must use effective barrier contraception during the study and for at least 120 days after last exposure to study drug
- Participants must not donate sperm or eggs during the study and for at least 120 days after last exposure to study drug
You will not qualify if you...
- Any uncontrolled disease or condition considered risky or interfering with study objectives by the investigator
- Active central nervous system SLE causing significant cognitive impairment affecting consent or compliance
- Comorbidities requiring systemic corticosteroid therapy (oral, rectal, injectable), but stable inhaled, topical, ophthalmic, otic, or intranasal corticosteroids allowed
- Active significant infections or major infections requiring hospitalization or parenteral anti-infectives within 4 weeks before or during screening
- History of positive HIV, hepatitis B or C infections at screening
- Active tuberculosis or untreated latent tuberculosis infection
- History of malignancy within 10 years prior to screening, except treated skin basal or squamous cell carcinoma (up to 3 lesions lifetime) or treated carcinoma in situ/cervical intraepithelial neoplasia
- Live or live-attenuated vaccines within 1 month before or during screening
- Recent changes or initiation of certain blood pressure medicines within 2 weeks before or during screening
- Treatment with Voclosporin or Cyclophosphamide at screening
- Use of other investigational agents within last 3 months or as required by prior protocols
- Clinically significant lab abnormalities unless due to active SLE
- Significant chest imaging abnormalities or active tuberculosis on chest X-ray
- Pregnant or breastfeeding women
- Inability or unwillingness to follow contraception requirements
AI-Screening
AI-Powered Screening
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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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