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

Immunoforge

Status and phase: Enrolling; Phase 2

Conditions: Dermatomyositis; Polymyositis; Idiopathic Inflammatory Myopathies

Treatments: Drug: Placebo; Drug: Froniglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05833711

PF1801-CL-202

Details and patient eligibility

About

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")

Enrollment: 39 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 3 patient groups, including a placebo group

Froniglutide 50 mg

Experimental group

Description:

Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.

Treatment:

Drug: Froniglutide

Froniglutide 70 mg

Experimental group

Description:

Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.

Treatment:

Drug: Froniglutide

Placebo

Placebo Comparator group

Description:

Matching placebo will be administered subcutaneously once a week.

Treatment:

Drug: Placebo