Recruiting

Testing a new medication for lupus kidney disease

Plain-English translation of NCT07107659 on ClinicalTrials.gov ↗ · Source last updated November 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is studying a new medication called ONT01 to see if it can help treat lupus and lupus nephritis (kidney inflammation caused by lupus). The study will test whether ONT01 is safe and tolerable in people with lupus, and whether taking it alongside standard lupus medications can improve symptoms, particularly for patients whose kidney disease hasn't responded well to current treatments.

Many people with lupus—especially those with kidney involvement—don't get better with existing treatments alone. This medication is being studied to find a new option that might work better, particularly for patients who haven't improved after trying standard therapies.

Do you qualify?

You likely qualify if…

you are 18 years or older and able to give informed consent
you have been diagnosed with systemic lupus erythematosus (SLE) and meet official classification criteria for the disease
you have active lupus symptoms and have already tried at least one standard lupus medication without adequate improvement
you have lupus kidney disease (Class III, IV, or V on biopsy) with significant protein in your urine and have not adequately responded to at least 3 months of standard kidney-protective therapy
you are willing to use effective contraception during the study and for 4 months after your last dose of medication

You likely don't qualify if…

you have serious uncontrolled medical conditions like severe asthma, lung disease, or heart problems that could make the study risky
you have active lupus affecting your brain with cognitive impairment that would prevent you from understanding or following the study
you have other medical conditions (like asthma or inflammatory bowel disease) that require ongoing oral or injected corticosteroids
you are unable or unwilling to follow the study requirements and visit schedule

What participation looks like

If you qualify, you would take ONT01 along with your standard lupus medications over a defined study period, attending regular clinic visits to check your kidney function, urine protein levels, and how you're tolerating the new medication. The study will monitor whether your lupus symptoms improve and watch carefully for any side effects. In total, 61 people will participate in this early-stage research.

AI-generated summary from trial data · Jun 11, 2026 · Not medical advice

Trial locations(1 site)

United States

Hospital for Special Surgery, New York, New York