A Study in Patients With Mild-to-moderate Lupus
The main purpose of this study is to assess the safety and tolerability of CUG252 following multiple ascending doses in patients with Lupus (SLE).
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 SLE (Systemic Lupus) 🦠 Autoimmune
🗓️ Study Start (Actual) 24 April 2023
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) July 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Anniston, Alabama, United States
📍 La Jolla, California, United States
📍 Clearwater, Florida, United States
📍 Tampa, Florida, United States
📍 Lawrenceville, Georgia, United States
📍 Columbus, Ohio, United States
📍 Middleburg Heights, Ohio, United States
📍 Duncansville, Pennsylvania, United States
📍 Dallas, Texas, United States
📍 Mesquite, Texas, United States
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2023
  • First Submitted that Met QC Criteria 10 May 2023
  • First Posted 19 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 May 2023
  • Last Update Posted 19 May 2023
  • Last Verified May 2023