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

NCT05866861 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CUG252-P102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 11

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).

Conditions

Systemic Lupus Erythematosus; SLE (Systemic Lupus); Autoimmune

Outcome Measures

Primary Outcomes (1)

• Number and percentage of subjects with Treatment Emergent Adverse Events

  To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.

  Up to 64 Days

Secondary Outcomes (6)

• Pharmacokinetics profile of CUG252 (AUC)

  Day 1 pre dose through Day 64

• Pharmacokinetics profile of CUG252 (Cmax)

  Day 1 pre dose through Day 64

• Pharmacokinetics profile of CUG252 (Tmax)

  Day 1 pre dose through Day 64

• Pharmacokinetics profile of CUG252 (t1/2)

  Day 1 pre dose through Day 64

• Immunogenicity of CUG252

  Day 1 pre dose through Day 64

Study Arms (2)

CUG252

EXPERIMENTAL

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

Drug: CUG252

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CUG252 DRUG

CUG252 will be administered by subcutaneous injection.

CUG252

Placebo DRUG

Placebo will be administered by subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have one or more of the following medical conditions: SARS-CoV-2 infection 30 days prior to drug administration, evidence of Grade 3 or greater hematologic, hepatic, or rental dysfunction, active severe or unstable neuropsychiatric SLE, active severe renal disease, history of severe active lupus nephritis with proteinuria levels greater than 1.0 g/24 hours, or dialysis in the last 6 months. History of current diagnosis of other autoimmune/inflammatory diseases, history of any non-SLE disease that has required treatment with corticosteroids for more than 2 weeks within the last 12 weeks prior to Screening, active clinically significant bacterial, viral, or fungal infection at Screening, active or latent TB at Screening, pulmonary infection or active lung disease besides those related to lupus, or severe pulmonary disease requiring oxygen therapy. History of condition that predisposes participant to infection, confirmed positive serology at Screening, history of opportunistic infection requiring hospitalization or IV antimicrobial treatment within the last year, history of organ or hematopoietic stem cell transplant, history of major surgery within 12 weeks of Screening, history of significant cardiovascular disease, history of gastrointestinal bleeding, history of cancer apart from successfully treated squamous or basal cell carcinoma or cervical cancer in situ.
• Are on one or more of the following medications: have received vaccination within 30 days prior to Screening (including COVID-19 vaccination), Aldesleukin or other IL-2 derivatives at any time, T cell depleting agents and inhibitors of T cell activation at any time, Anti-BLyS/BAFF inhibitors, IL-1 receptor antagonist, anti-TNF therapy, and anti-interferon alpha receptor inhibitor within 3 months prior to Screening, rituximab or other B-cell depleting agent within 6 months, glucocorticoids within 6 weeks prior to Day 1, other immunosuppressant drugs within 8 weeks, history of cytotoxic medications within 12 months, receipt of blood products within 6 months, plasmapheresis within 30 days of Screening.

Sponsors & Collaborators

• Cugene Inc.: lead

Study Sites (11)

Site 1001

Anniston, Alabama, 36207, United States

Location

Site 1011

La Jolla, California, 92037, United States

Location

Site 1002

Clearwater, Florida, 33765, United States

Location

Site 1009

Tampa, Florida, 33606, United States

Location

Site 1007

Lawrenceville, Georgia, 30046, United States

Location

Site 1010

Columbus, Ohio, 44106, United States

Location

Site 1005

Middleburg Heights, Ohio, 44130, United States

Location

Site 1003

Duncansville, Pennsylvania, 16635, United States

Location

Site 1006

Dallas, Texas, 75231, United States

Location

Site 1004

Mesquite, Texas, 75150, United States

Location

Site 1012

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 19, 2023
• Study Start: April 24, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

US (11)