Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (FROG)
Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies
About this trial
This is an interventional treatment trial for Dermatomyositis
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
Sites / Locations
- Hanyang University Seoul HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Froniglutide 50 mg
Froniglutide 70 mg
Placebo
Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.
Matching placebo will be administered subcutaneously once a week.