Study Evaluating Efficacy and Safety of Froniglutide (PF1... | NCT05833711

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

NCT05833711

Sponsor

Immunoforge Co. Ltd.

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

39Estimated

Phase

Phase 2

Conditions

Dermatomyositis
Polymyositis
Idiopathic Inflammatory Myopathies

Interventions

Froniglutide
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2023Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Apr 16, 2023

First Submission Date that Met QC Criteria

Apr 16, 2023

First Posted Date

Apr 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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")

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Froniglutide 50 mg	Experimental	Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.	Drug: Froniglutide
Froniglutide 70 mg	Experimental	Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.	Drug: Froniglutide
Placebo	Placebo Comparator	Matching placebo will be administered subcutaneously once a week.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Froniglutide	Drug	SC Weekly Injection	Froniglutide 50 mg Froniglutide 70 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	Week 4, 8, 12, 16, 24

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Minhee Song	Contact	+82-4946-8465		mini@immunoforge.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Seoul Hospital	Recruiting	Seoul		04763	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003882	Dermatomyositis
D017285	Polymyositis
D009220	Myositis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided