Evaluating Froniglutide for 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)
This study is testing a new medication called Froniglutide to see if it can help people with idiopathic inflammatory myopathy, like dermatomyositis and polymyositis, feel stronger and healthier.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Immunoforge Co. Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05833711 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study aims to assess the efficacy and safety of Froniglutide (PF1801) in patients diagnosed with idiopathic inflammatory myopathy, including dermatomyositis and polymyositis. The study employs a randomized, double-blind, placebo-controlled design to ensure unbiased results. Participants will be monitored for pharmacokinetics and various clinical outcomes related to their muscle strength and overall health. The study will include patients who have been on stable standard of care treatments for at least four weeks prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with idiopathic inflammatory myopathy who have been on stable immunosuppressive therapy for at least 12 weeks.
Not a fit: Patients with inclusion body myositis, severe muscle damage, or significant renal/hepatic impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from idiopathic inflammatory myopathy.
How similar studies have performed: Other studies have explored treatments for idiopathic inflammatory myopathy, but the specific approach with Froniglutide is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Hanyang University Seoul Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Minhee Song
- Email: mini@immunoforge.com
- Phone: +82-4946-8465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.