CUG252 for Lupus

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Cugene Inc.

Trial Summary

What is the purpose of this trial?This trial tests CUG252, a new medicine for people with Systemic Lupus Erythematosus (SLE). It aims to enhance beneficial immune cells while reducing unwanted immune activity. The study will check its safety and effectiveness over time.

Eligibility Criteria

This trial is for adults aged 18-65 with mild-to-moderate Systemic Lupus Erythematosus (SLE). Participants must have been diagnosed at least 6 months prior and have a stable medication regimen if they're taking prednisone or other specific SLE treatments. They should also meet certain body weight criteria.

Inclusion Criteria

BMI greater than or equal to 18 and less than 39 kg/m2 at Screening

My lupus activity is low to moderate.

I have been on a stable dose of 20 mg/day or less of prednisone for at least 8 weeks.

+3 more

Participant Groups

The study tests the safety of multiple doses of a new drug, CUG252, compared to a placebo in people with SLE. The goal is to see how well participants tolerate this potential new treatment for lupus symptoms.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CUG252Experimental Treatment1 Intervention

CUG252 or placebo will be administered to participants in a 3:1 ratio.

Group II: PlaceboPlacebo Group1 Intervention

CUG252 or placebo will be administered to participants in a 3:1 ratio.