NCT05833711
Recruiting
Phase 2
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)
Overview
- Phase
- Phase 2
- Intervention
- Froniglutide
- Conditions
- Dermatomyositis
- Sponsor
- Immunoforge Co. Ltd.
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- IMACS-TIS Moderate Improvement at Week 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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")
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Froniglutide 50 mg
Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
Intervention: Froniglutide
Froniglutide 70 mg
Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.
Intervention: Froniglutide
Placebo
Matching placebo will be administered subcutaneously once a week.
Intervention: Placebo
Outcomes
Primary Outcomes
IMACS-TIS Moderate Improvement at Week 24
Time Frame: Week 24
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
Secondary Outcomes
- IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24(Week 4, 8, 12, 16, 24)
Study Sites (1)
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