Safety and Efficacy of ONT01 in Lupus

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 4, 2026

Primary Completion Date

May 31, 2030

Study Completion Date

May 31, 2030

Conditions
Lupus Nephritis (LN)Lupus Nephritis - WHO Class IIILupus Nephritis - WHO Class IVLupus Nephritis - World Health Organization (WHO) Class IIILupusSLESystemic Lupus ErythematosusSystemic 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.

Trial Locations (1)

10021

Hospital for Special Surgery, New York

All Listed Sponsors
collaborator

The University of Texas Medical Branch, Galveston

OTHER

lead

Hospital for Special Surgery, New York

OTHER

NCT07107659 - Safety and Efficacy of ONT01 in Lupus | Biotech Hunter | Biotech Hunter