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

Dermatomyositis Clinical Trial

— FROG  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833711
• Other study ID #: PF1801-CL-202
• Status: Recruiting
• Phase: Phase 2
• Start date: September 5, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Immunoforge Co. Ltd.
• Contact: Minhee Song
• Phone: +82-4946-8465
• Email: mini[@]immunoforge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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")

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Idiopathic Inflammatory Myopathies
• Muscular Diseases
• Myositis
• Polymyositis

Intervention

Drug:
• Froniglutide
SC Weekly Injection
• Placebo
SC Weekly Injection

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Immunoforge Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMACS-TIS Moderate Improvement at Week 24	Proportion of subjects who achieve moderate improvement (=40) from baseline in IMACS TIS at Week 24	Week 24
Secondary	IMACS-TIS Minimal Improvement at 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	Week 4, 8, 12, 16, 24