NCT05833711

Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Immunoforge Co. Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")

Conditions

• Dermatomyositis
• Polymyositis
• Idiopathic Inflammatory Myopathies

Interventions

Type	Name	Description
DRUG	Froniglutide	SC Weekly Injection
DRUG	Placebo	SC Weekly Injection

Timeline

• Start date: 2023-09-05
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2023-04-27
• Last updated: 2023-09-13

Locations

1 site across 1 country: South Korea