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
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male or female participant, aged 18 to 65 years (inclusive), at time of consent

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

• Diagnosis of SLE at least 6 months prior to Screening

• Minimal to moderate SLE disease activity

• If a participant is taking oral prednisone, the dose must be less than or equal to 20 mg/day for a minimum of 8 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening

• If a participant is taking azathioprine, antimalarial, mycophenolate mofetil, or methotrexate, the medication(s) must have been started a minimum of 12 weeks prior to Screening and at a stable dose for a minimum of 8 weeks prior to Screening

Locations
United States
Alabama
Site 1001
Anniston
California
Site 1011
La Jolla
Florida
Site 1002
Clearwater
Site 1009
Tampa
Georgia
Site 1007
Lawrenceville
Ohio
Site 1010
Columbus
Site 1005
Middleburg Heights
Pennsylvania
Site 1003
Duncansville
Texas
Site 1006
Dallas
Site 1004
Mesquite
Washington
Site 1012
Seattle
Time Frame
Start Date: 2023-04-24
Completion Date: 2025-04-01
Participants
Target number of participants: 40
Treatments
Experimental: CUG252
CUG252 or placebo will be administered to participants in a 3:1 ratio.
Placebo_comparator: Placebo
CUG252 or placebo will be administered to participants in a 3:1 ratio.
Related Therapeutic Areas
Sponsors
Leads: Cugene Inc.

This content was sourced from clinicaltrials.gov

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