ONT01 for Lupus

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Hospital for Special Surgery, New York

Must be taking: Mycophenolate mofetil

Must not be taking: Voclosporin, Cyclophosphamide

Disqualifiers: Uncontrolled disease, Active CNS SLE, Infections, HIV, Hepatitis, TB, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ONT01, to determine its safety and effectiveness in treating lupus, specifically Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE). Researchers aim to assess how well ONT01 works when combined with standard lupus treatments like mycophenolate mofetil. Suitable candidates for this trial are those with active lupus symptoms that have not improved with other treatments. As an Early Phase 1 trial, this research focuses on understanding ONT01's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that the study looks at how ONT01 works with other lupus treatments, so you might be able to continue some medications. It's best to discuss this with the trial team.

Is there any evidence suggesting that ONT01 is likely to be safe for humans?

Research has shown that ONT01 is under study to determine its safety for treating lupus nephritis (a kidney problem caused by lupus) and systemic lupus erythematosus (a condition where the immune system attacks the body). As ONT01 is in the early testing phase, limited information exists about its tolerability. Scientists are still assessing potential side effects and overall safety. This phase of research focuses primarily on safety, and any findings regarding side effects will inform future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lupus, which typically include corticosteroids and immunosuppressants, ONT01 offers a novel approach. Researchers are excited because ONT01 targets the underlying mechanisms of lupus more precisely, potentially reducing inflammation and kidney damage associated with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE). This targeted action could mean fewer side effects and improved outcomes for patients, making it a promising candidate for those who don't respond well to current therapies.

What evidence suggests that ONT01 might be an effective treatment for lupus?

Research has shown that ONT01 is being tested as a potential treatment for Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) in this trial. Although the FDA has not yet approved ONT01, researchers believe it may help by interacting with the immune system to reduce inflammation and damage caused by lupus. Early results suggest that ONT01, when combined with current lupus treatments like mycophenolate mofetil, might improve symptoms. However, detailed information on its effectiveness remains limited. Ongoing studies aim to better understand ONT01's efficacy and safety for people with lupus. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Lupus Nephritis or Systemic Lupus Erythematosus. Participants must be suitable for treatment with mycophenolate mofetil, among other standard lupus medications. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have been diagnosed with systemic lupus erythematosus (SLE).

I am 18 years or older and can give my consent.

I have active lupus not affecting my kidneys and a treatment didn't work for me.

Exclusion Criteria

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry

I cannot or will not follow the study's birth control rules.

Any condition, including any uncontrolled disease, that in the Sponsor-Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ONT01 in combination with standard lupus treatments to assess safety and efficacy

18 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ONT01

Trial Overview ONT01, a small molecule CD11b modulator, is being tested to see if it's safe and can help improve symptoms when used alongside common lupus treatments like mycophenolate mofetil. The study will involve 61 participants.

How Is the Trial Designed?

Group I: This study will treat patients with Lupus Nephritis (LN) or Systemic Lupus Erythematosus (SLE). Experimental Treatment 1 Intervention

Lupus Nephritis

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

The University of Texas Medical Branch, Galveston

Collaborator

Trials

263

Recruited

55,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07107659

NCT07107659 | Safety and Efficacy of ONT01 in Lupus 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.

2. app.trialscreen.org app.trialscreen.org/trials/early-phase-1-safety-efficacy-ont01-lupus-trial-nct07107659

Safety and Efficacy of ONT01 in Lupus This Interventional study is looking for people with Lupus Nephritis (LN), Lupus Nephritis - WHO Class III in New York United States to take part.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07107659/safety-and-efficacy-of-ont01-in-lupus

Safety and Efficacy of ONT01 in Lupus 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10348374/

Promising Experimental Treatments for Lupus Nephritis Most clinical trials of new biological therapies have failed to meet their primary endpoints in both general SLE and LN, with only two ...

5. sigma.larvol.com sigma.larvol.com/disease.php?e1=19660&e2=&DiseaseId=19660&tab=DiseaseOTT&sr=now&er=1+month&ipwnd=on&rlink=,DiseaseId=19660,tab=DiseaseOTT&rflag=1&page=2

Lupus Nephritis Trials 2022-001796-14: An open-label study to assess safety, efficacy and cellular kinetics of YTB323 in severe, refractory systemic lupus erythematosus (srSLE).

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499817/

Lupus Nephritis - StatPearls - NCBI Bookshelf Lupus nephritis is a severe manifestation of systemic lupus erythematosus (SLE)—a chronic autoimmune disease that causes inflammation and damage ...

7. prnewswire.com prnewswire.com/news-releases/lupus-nephritis-clinical-trial-pipeline-experiences-momentum-delveinsight-estimates-a-diverse-pipeline-comprising-30-companies-working-in-the-domain-302320381.html

Lupus Nephritis Clinical Trial Pipeline Experiences ... Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems.