A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041568
• Other study ID #: IGM-2323-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 15, 2023
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: IGM Biosciences, Inc.
• Contact: Clinical Trials
• Phone: (877) 544-6728
• Email: IGM-2323-101[@]igmbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Imvotamab
Administered intravenously

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie	Nadarzyn
United States	Stryde Research	Allen	Texas
United States	Omega Research, DeBary	DeBary	Florida
United States	Precision Comprehensive Clinical Research	Grapevine	Texas
United States	Care and Cure Clinic	Houston	Texas
United States	Prolato Clinical Research Center	Houston	Texas
United States	Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	TriWest Research Associates	San Diego	California
United States	East Bay Rheumatology	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
IGM Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of imvotamab	Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections	Up to Week 52