ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Trial end date: 2019-02-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iltoo Pharma

Criteria

Inclusion Criteria:

• Confirmed diagnosis of SLE

• Active SLE

• On stable background therapy for 1 month

• Using highly effective contraception

Exclusion Criteria:

• Serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure)

• Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C

• Clinical significant pleuritis or pericarditis

• Type1 Diabetes and/or CROHN's disease

• Use of Benlysta (belimumab) in the past 4 weeks

• Use of Rituximab in the past 6 months

• Vaccination with live attenuated virus in the last month