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

Primary Purpose

Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Froniglutide
Placebo
Sponsored by
Immunoforge Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Froniglutide 50 mg

Froniglutide 70 mg

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

IMACS-TIS Minimal Improvement at 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

Full Information

First Posted
April 16, 2023
Last Updated
September 11, 2023
Sponsor
Immunoforge Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05833711
Brief Title
Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
Acronym
FROG
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunoforge Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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")

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Froniglutide 50 mg
Arm Type
Experimental
Arm Description
Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
Arm Title
Froniglutide 70 mg
Arm Type
Experimental
Arm Description
Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered subcutaneously once a week.
Intervention Type
Drug
Intervention Name(s)
Froniglutide
Other Intervention Name(s)
PF1801
Intervention Description
SC Weekly Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC Weekly Injection
Primary Outcome Measure Information:
Title
IMACS-TIS Moderate Improvement at Week 24
Description
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24
Description
Proportion of subjects who achieve minimal improvement (≥20) from baseline in IMACS TIS at Week 4, 8, 12, 16, and 24
Time Frame
Week 4, 8, 12, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhee Song
Phone
+82-4946-8465
Email
mini@immunoforge.com
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae-Hyun Yoo, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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