NCT05866861

A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus

A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following Multiple Dose Administrations in Participants With Mild-to-Moderate SLE

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cugene Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).

Detailed description

CUG252 is a potential best-in-class engineered IL-2 compound, designed to have improved Treg selectivity while reducing undesired IL-2 activity. This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunologic effects of CUG252 following subcutaneous administration of multiple ascending doses in participants with mild-to-moderate SLE. The effects of SLE disease activity and biomarkers will also be evaluated.. The SLE participants will receive randomized multiple subcutaneous doses of CUG252 or placebo. After receiving the last dose of CUG252 or placebo, participants will be followed to study day 64 post first dose administration to evaluate safety, PK, PD and preliminary efficacy.

Conditions

• Systemic Lupus Erythematosus
• SLE (Systemic Lupus)
• Autoimmune

Interventions

Type	Name	Description
DRUG	CUG252	CUG252 will be administered by subcutaneous injection.
DRUG	Placebo	Placebo will be administered by subcutaneous injection.

Timeline

• Start date: 2023-04-24
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-05-19
• Last updated: 2025-02-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study