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

Launched by IMMUNOFORGE CO. LTD. · Apr 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Froniglutide (PF1801) to see how well it works and how safe it is for patients with idiopathic inflammatory myopathy (IIM), which includes conditions like dermatomyositis and polymyositis. The trial is in Phase 2, meaning it’s looking to gather more information about the medication after earlier testing. It involves participants aged 6 to 92 years and is currently recruiting people to join.

To be eligible for this study, participants must have a confirmed diagnosis of IIM and show specific signs of muscle weakness. They also need to have been receiving standard treatment (like immunosuppressants or corticosteroids) for at least 12 weeks, with their medication stable for the past 4 weeks. Participants will be randomly assigned to receive either Froniglutide or a placebo (which looks like the medication but has no active ingredients) without knowing which one they got. Throughout the trial, patients will be monitored for any effects of the medication and how their condition changes. This study aims to provide valuable information on a potential new treatment option for those suffering from these challenging muscle disorders.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Diagnosis of IIM (DM or polymyositis \[PM\]) as per Bohan and Peter classification criteria
• • MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 \>125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
• • On treatment with standard of care (immunosuppressants and/or corticosteroids) for \>12 weeks and on stable therapy for at least 4 weeks
• Key Exclusion Criteria:
• • Inclusion body myositis (IBM) or amyopathic DM
• • Severe muscle damage (myositis damage index \[MDI\] \>7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
• • Clinically significant renal/hepatic impairment
• • Severe interstitial lung disease requiring supportive oxygen therapy