A Study of Imvotamab in Severe Systemic Lupus Erythematosus
Reason given: Company Decision.
Key facts
- Where
- Allen, DeBary, Grapevine, Houston, Plantation, San Diego, and San Leandro, United StatesSee the 8 sites
- Phase
- Phase 1
Where in United States
- Stryde ResearchAllen, United StatesNo longer taking part
- Omega Research DeBaryDeBary, United StatesNo longer taking part
- Precision Comprehensive Clinical ResearchGrapevine, United StatesNo longer taking part
- Care and Cure ClinicHouston, United StatesNo longer taking part
- Prolato Clinical Research CenterHouston, United StatesNo longer taking part
- Integral Rheumatology & Immunology SpecialistsPlantation, United StatesNo longer taking part
- Triwest Research AssociatesSan Diego, United StatesNo longer taking part
- East Bay RheumatologySan Leandro, United StatesNo longer taking part
Trial details
- Who runs it
- IGM Biosciences, Inc.
- Trial code
- NCT06041568
- Record updated
- 10 February 2025
- Original description
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.Read full original descriptionShow less
A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies
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).
Inclusion: 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: Drug-induced lupus; Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening; 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; Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab; Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.