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

Sponsor
Immunoforge Co. Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05833711
Collaborator
(none)
39
Enrollment
3
Arms
27
Anticipated Duration (Months)

Study Details

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")

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Froniglutide 50 mg

Drug: Froniglutide
SC Weekly Injection
Other Names:
  • PF1801

    		•
    Experimental: Froniglutide 70 mg

    Drug: Froniglutide
    SC Weekly Injection
    Other Names:
  • PF1801

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    SC Weekly Injection

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Immunoforge Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immunoforge Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT05833711
    Other Study ID Numbers:
    • PF1801-CL-202
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    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
    Additional relevant MeSH terms:
    Muscular Diseases
    Dermatomyositis
    Polymyositis
    Myositis

    Study Results

    No Results Posted as of Apr 27, 2023