Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-29 @ 8:19 PM
Study NCT ID:
NCT05866861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
Sponsor:
Cugene Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: