Study on Imvotamab in Severe Lupus
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 Lupus Erythematosus
🗓️ Study Start (Actual) 15 August 2023
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 18
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 San Diego, California, United States
📍 San Leandro, California, United States
📍 DeBary, Florida, United States
📍 Plantation, Florida, United States
📍 Allen, Texas, United States
📍 Grapevine, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 Seoul, Korea, Republic of
📍 Nadarzyn, Poland

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age ≥ 18 years at the time of signing ICF
    • * Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
    • * Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
    • * Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
    • * It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.

    Exclusion Criteria:

    • * Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
    • * Any lupus-associated neuropsychiatric disease.
    • * Active lupus nephritis with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
    • * Prednisone-equivalent \> 30 mg/day, including immediate and extended-release oral formulations.
    • * Drug-induced lupus.
    • * Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
Ages Eligible for Study: 18 Years to N/A (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 11 September 2023
  • First Submitted that Met QC Criteria 11 September 2023
  • First Posted 18 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024