Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (FROG)
Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies
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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.