Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
FROG
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)
1 other identifier
interventional
39
1 country
1
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")
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedStudy Start
First participant enrolled
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 13, 2023
September 1, 2023
1.5 years
April 16, 2023
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
IMACS-TIS Moderate Improvement at Week 24
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
Week 24
Secondary Outcomes (1)
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24
Week 4, 8, 12, 16, 24
Study Arms (3)
Froniglutide 50 mg
EXPERIMENTALFroniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
Froniglutide 70 mg
EXPERIMENTALFroniglutide (PF1801) 70 mg will be administered subcutaneously once a week.
Placebo
PLACEBO COMPARATORMatching placebo will be administered subcutaneously once a week.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2023
First Posted
April 27, 2023
Study Start
September 5, 2023
Primary Completion
March 1, 2025
Study Completion
September 1, 2025
Last Updated
September 13, 2023
Record last verified: 2023-09