NCT06524687

A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

A Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Adult Participants With Active, Refractory Moderate-Severe Idiopathic Inflammatory Myopathies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: IGM Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 1b, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.

Conditions

• Idiopathic Inflammatory Myopathies
• Inflammatory Myopathies

Interventions

Type	Name	Description
DRUG	Imvotamab	Administered intravenously

Timeline

• Start date: 2024-05-29
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2024-07-29
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study