2-HOBA in Systemic Lupus Erythematosus

Conditions

• Systemic Lupus Erthematosus (SLE)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 2-HOBA acetate (2-Hydroxybenzlamine acetate) — DRUG
  2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day
• Placebo — DRUG
  Placebo (provided as two capsules) three times per day

Study Details

This is a phase II randomized, placebo-controlled, double-blind, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE. 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 500mg 2-HOBA three times a day for 8 weeks followed by a 4 week washout and then 8 weeks of the other agent. Primary outcome measures include change in 24-hour blood pressure and NETosis. This study will provide mechanistic information on the role of IsoLGs in autoimmune disease-associated hypertension and immune activation.

Key Dates

Start date

May 15, 2026

Status verified

May 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Placebo First
  Placebo for first 8 weeks, then washout for 4 weeks, and then 2-HOBA acetate for 8 weeks
• Experimental: 2-HOBA First
  2-HOBA acetate for first 8 weeks, then washout for 4 weeks, and then placebo for 8 weeks

Primary Outcome Measure

24-hour systolic blood pressure [ Time Frame: Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20. ]

Central Contacts

• Phicharmon Kulapatana (study coordinator)
  615-936-5747
  [email protected]

Locations (1)

Find similar trials in Nashville, TN