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

Phase 2

Recruiting

• Conditions: Idiopathic Inflammatory Myopathies; Dermatomyositis; Polymyositis
• Interventions: Drug: Placebo; Drug: Froniglutide

• Registration Number: NCT05833711
• Lead Sponsor: Immunoforge Co. Ltd.

Brief 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")

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-27
• Status Verified: 2023-09
• Study Start: 2023-09-05
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo will be administered subcutaneously once a week.
Froniglutide 50 mg	Froniglutide	Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
Froniglutide 70 mg	Froniglutide	Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.

Primary Outcome Measures

Name	Time	Method
IMACS-TIS Moderate Improvement at Week 24	Week 24	Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24

Secondary Outcome Measures

Name	Time	Method
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24	Week 4, 8, 12, 16, 24	Proportion of subjects who achieve minimal improvement (≥20) from baseline in IMACS TIS at Week 4, 8, 12, 16, and 24

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of