NCT06087406

A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

A Phase 1b, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Failed Prior Therapies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (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 to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug

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 active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 40 participants will be sequentially assigned to different dose escalation cohorts.

Conditions

• Rheumatoid Arthritis
• Arthritis, Rheumatoid
• Arthritis

Interventions

Type	Name	Description
DRUG	Imvotamab	Administered intravenously
DRUG	Placebo	0.9% sodium chloride administered intravenously

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2023-10-17
• Last updated: 2025-02-18

Locations

18 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study