Status:
TERMINATED
A Study of Imvotamab in Severe Systemic Lupus Erythematosus
Lead Sponsor:
IGM Biosciences, Inc.
Conditions:
Systemic Lupus Erythematosus
Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 imv...
Detailed Description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with sy...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06041568
Start Date
August 15 2023
End Date
January 27 2025
Last Update
February 10 2025
Active Locations (10)
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1
TriWest Research Associates
San Diego, California, United States, 92108
2
East Bay Rheumatology
San Leandro, California, United States, 94578
3
Omega Research, DeBary
DeBary, Florida, United States, 32713
4
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States, 33324