Clinical trial NCT06041568: A Study of Imvotamab in Severe Systemic Lupus Erythematosus
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lupus Erythematosus
Keywords: Lupus
SLE
Severe Lupus
Severe systemic lupus erythematosus
Systemic lupus erythematosus
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 imvotamab through a vein (i.e., intravenously).

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 systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.

Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Safety and tolerability of imvotamab
timeFrame: Up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TriWest Research Associates
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology
state: California
city: DeBary
country: United States
facility: Omega Research, DeBary
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Allen
country: United States
facility: Stryde Research
state: Texas
city: Grapevine
country: United States
facility: Precision Comprehensive Clinical Research
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Care and Cure Clinic
state: Texas
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Nadarzyn
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
Study officials:
affiliation: IGM Biosciences
name: Rebecca Kunder
role: STUDY_DIRECTOR
References: