NCT06041568

A Study of Imvotamab in Severe Systemic Lupus Erythematosus

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (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 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.

Conditions

• Systemic Lupus Erythematosus
• Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Imvotamab	Administered intravenously

Timeline

• Start date: 2023-08-15
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2023-09-18
• Last updated: 2025-02-10

Locations

10 sites across 3 countries: United States, Poland, South Korea

Regulatory

• FDA-regulated drug study