Safety and Efficacy of ONT01 in Lupus

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT07107659
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONT01 is a small molecule CD11b modulator. — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 4, 2026
Status verified
Nov 2025
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
61 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: This study will treat patients with Lupus Nephritis (LN) or Systemic Lupus Erythematosus (SLE).
    Lupus Nephritis

Primary Outcome Measure

Adverse Events, Study Completion versus Withdrawal [ Time Frame: From Enrollment until 18 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Timothy B Niewold, MD
[email protected]
646 797-8698
Christele Felix
[email protected]
646 714-6196
Timothy B Niewold, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Hospital for Special Surgery· New York, NY

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