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Tests treatment safety and results for Lupus Nephritis (LN)
Official title Safety and Efficacy of ONT01 in Lupus
ClinicalTrials.gov ID: NCT07107659
What this study is testing
What is ONT01 is a small molecule CD11b modulator.?
ONT01 is a small molecule CD11b modulator. is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lupus nephritis (ln).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years old and able to provide informed consent to participate.
- Diagnosis of SLE and have fulfilled the ACR classification criteria for SLE during the course of their disease.
- Active non-renal SLE, with one active non-renal clinical manifestation, who have failed at least 1 disease modifying anti-rheumatic drug (DMARD)...
- Active non-renal SLE is defined as having a SLEDAI of 6 or greater (with at least 1 non-renal clinical domain) OR Active nephritis defined as having...
- Active LN is defined as follows: a. kidney biopsy showing Class III, IV, V, III+V, or IV+V, within 1 year from screening, AND b. 24-hour urine...
You likely can't join if
- Any condition, including any uncontrolled disease (eg, asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in...
- Active central nervous system SLE associated with significant cognitive impairment leading to inability to provide informed consent and/or comply...
- Comorbidities requiring systemic corticosteroid (CS) therapy, such as asthma or inflammatory bowel disease. Systemic is defined as oral, rectal or...
- Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with...
- History of positive human immunodeficiency virus (HIV), hepatitis C antibody and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg)...
- History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a positive QuantiFERON test at the...
See the full eligibility criteria
Who can join
- ≥ 18 years old and able to provide informed consent to participate.
- Diagnosis of SLE and have fulfilled the ACR classification criteria for SLE during the course of their disease.
- Active non-renal SLE, with one active non-renal clinical manifestation, who have failed at least 1 disease modifying anti-rheumatic drug (DMARD) therapy (not including hydroxychloroquine and corticosteroids)
- Active non-renal SLE is defined as having a SLEDAI of 6 or greater (with at least 1 non-renal clinical domain) OR Active nephritis defined as having a no or partial response after initial induction and maintenance...
- Active LN is defined as follows: a. kidney biopsy showing Class III, IV, V, III+V, or IV+V, within 1 year from screening, AND b. 24-hour urine protein/creatinine ratio \>=1g/g at screening, AND c. absence of partial...
- Partial renal response (PRR) is defined as a. 24-hour UPCR improved by \>=25% after 3 months from the start of induction standard of care (SOC) therapy (baseline), or \>= 50% after 6 months from the induction therapy...
- Female patients who are women of childbearing potential must agree to use a highly effective form of contraception during the study and for at least 120 days after last exposure to study drug. Male patients with female...
What rules you out
- Any condition, including any uncontrolled disease (eg, asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in the Sponsor-Investigator's opinion constitutes an inappropriate risk or...
- Active central nervous system SLE associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol.
- Comorbidities requiring systemic corticosteroid (CS) therapy, such as asthma or inflammatory bowel disease. Systemic is defined as oral, rectal or any injectable route of administration (thus stable dosing by other...
- Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during the Screening...
- History of positive human immunodeficiency virus (HIV), hepatitis C antibody and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+), and/or hepatitis B core IgG and/or IgM antibody (+) at the...
- History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a positive QuantiFERON test at the Screening Visit
- History of malignancy (hematologic or solid tumor) within 10 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in...
- Immunization with live or live-attenuated vaccines within 1 month before or during the Screening period.
- Initiation of, or change in, dosing of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker within 2 weeks before the Screening Visit or during the Screening period.
- Treatment with Voclosporin or Cyclophosphamide at time of screening.
- Treatment with other investigational agents within the last 3 months or 5 half-lives, or as per washout requirement from the previous protocol, whichever is longest, prior to the Screening Visit.
- Clinically significant abnormalities in laboratory tests, unless attributable to active SLE at the Screening Visit
- Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level \> 2.5 × upper limit of normal (ULN), or
- Total bilirubin \> 1.5 × ULN, or
- Hemoglobin \< 5.0 mmol/L [9 g/dL], or
- White blood cells \< 2.5 × 109/L, or
- Absolute neutrophil count \< 1500 /mm3, or
- Platelets \< 75 × 109/L
- Clinically significant chest imaging (e.g. X-ray, computed tomography or magnetic resonance imaging [MRI]) abnormalities per Sponsor-Investigator opinion (e.g. interstitial lung disease) or evidence of active TB on...
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Patients are unable or unwilling to adhere to the contraception requirements outlined in inclusion criteria 4.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.