A Study of Imvotamab in Severe Systemic Lupus Erythematosus

February 6, 2025 updated by: IGM Biosciences, Inc.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
  • Poland
      • Nadarzyn, Poland
        • Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
  • United States
    • California
      • San Diego, California, United States, 92108
        • TriWest Research Associates
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research, DeBary
      • Plantation, Florida, United States, 33324
        • Integral Rheumatology & Immunology Specialists
    • Texas
      • Allen, Texas, United States, 75013
        • Stryde Research
      • Grapevine, Texas, United States, 76051
        • Precision Comprehensive Clinical Research
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center
      • Houston, Texas, United States, 77090
        • Care and Cure Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imvotamab (Dose Escalation)
Imvotamab administered intravenously
Drug: Imvotamab
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of imvotamab
Time Frame: Up to Week 52
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IGM Biosciences, Inc.

Investigators

  • Study Director: Rebecca Kunder, IGM Biosciences

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 Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

January 27, 2025

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGM-2323-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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