A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

NCT06524687 | Terminated Phase 1 FDA Drug

• 1 other identifier: IGM-2323-103
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).

Conditions

Idiopathic Inflammatory Myopathies; Inflammatory Myopathies

Keywords

Myopathies; Moderate-Severe Myopathy; Myositis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of imvotamab

  Incidence of adverse events (AEs), serious adverse events (SAEs), including serious

  Time Frame: Up to Week 50

Study Arms (1)

Imvotamab (Dose Escalation)

EXPERIMENTAL

Imvotamab administered intravenously

Drug: Imvotamab

Interventions

Imvotamab DRUG

Administered intravenously

Imvotamab (Dose Escalation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of signing ICF
• Diagnosis of probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for IIM with subgroup classification of either DM, polymyositis (PM), anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).
• Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
• If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment

You may not qualify if:

• Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
• Receipt of an investigational therapy less than 12 weeks or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (1)

Standford University

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Myositis; Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Rebecca Kunder

  IGM Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: May 29, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)