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Safety and Efficacy of ONT01 in Lupus

NCT07107659 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-11-20

No results posted yet for this study

Summary

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

  • Lupus Nephritis (LN)
  • Lupus Nephritis - WHO Class III
  • Lupus Nephritis - WHO Class IV
  • Lupus Nephritis - World Health Organization (WHO) Class III
  • Lupus
  • SLE
  • Systemic Lupus Erythematosus
  • Systemic Lupus Erythematosus (Disorder)

Interventions

DRUG

ONT01 is a small molecule CD11b modulator.

ONT01 will be administered orally twice daily (in the morning and in the evening at approximately 12 hours apart and approximately the same time each day) and should be taken as whole tablets (not crushed) under fasted conditions (2 hours before and 1 hour after each dose) with 8 oz/240 mL of water.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-04
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107659 on ClinicalTrials.gov