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

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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05833711

Acronym

FROG

Enrollment

Registered

2023-04-27

Start date

2023-09-05

Completion date

2025-09-30

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis, Idiopathic Inflammatory Myopathies, Polymyositis

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)

Interventions

DRUGFroniglutide

SC Weekly Injection

DRUGPlacebo

SC Weekly Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
IMACS-TIS Moderate Improvement at Week 24	Week 24	Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24

Secondary

Measure	Time frame	Description
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24	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

Countries

South Korea

Contacts

Primary ContactMinhee Song

mini@immunoforge.com+82-4946-8465

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026