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Polymyositis clinical trials

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NCT ID: NCT05979441 Recruiting - Dermatomyositis Clinical Trials

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

ALKIVIA+
Start date: September 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

NCT ID: NCT05895786 Recruiting - Myositis Clinical Trials

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Start date: May 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older. - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 16 study visits. These visits will be performed at the study site.

NCT ID: NCT05833711 Recruiting - Dermatomyositis Clinical Trials

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

FROG
Start date: September 5, 2023
Phase: Phase 2
Study type: Interventional

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")

NCT ID: NCT05832034 Recruiting - Dermatomyositis Clinical Trials

Add-on Intravenous Immunoglobulins in Early Myositis

TIMEISMUSCLE
Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

In patients with myositis early immunomodulation by intensive treatment ("hit-early/hit-hard" principle) may induce faster reduction of disease activity and prevent chronic disability. Intravenous immunoglobulin (IVIg) in addition to standard treatment with glucocorticoids may be beneficial for this purpose: add-on IVIg improved symptoms in steroid-resistant myositis, and first-line monotherapy IVIg led to a fast and clinically relevant response in a pilot study in nearly 50% of patients with myositis.

NCT ID: NCT05650567 Recruiting - Dermatomyositis Clinical Trials

Study of M5049 in DM and PM Participants (NEPTUNIA)

Start date: January 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

NCT ID: NCT05637931 Not yet recruiting - Dermatomyositis Clinical Trials

Plexin D1 as a Potential Biomarker inPM/DM

Start date: December 25, 2022
Phase:
Study type: Observational

evaluation of level of serum circulating plexin D1 on extacellular vesicles in adult PM/DM patients and juvenile dermatomysitis.

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05027152 Not yet recruiting - Dermatomyositis Clinical Trials

Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for patients. The aim of this study is to correlate the "Myositis Functional Index-3 (FI-3)" with muscle function assessed by computerized isokinetic dynamometry, electromyography and magnetic resonance through an observational study; and to compare the effects of a repetitive task training program with a resistance exercise program through an interventional study in patients with inflammatory myopathies. It is expected that FI-3 will present a good correlation with muscle function assessed by computerized isokinetic dynamometry and electromyography, given its reduced cost and less time spent on evaluation. It is also expected to demonstrate that repetitive task training is as efficient and safe as resistance exercises.

NCT ID: NCT04976140 Enrolling by invitation - Dermatomyositis Clinical Trials

Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis

Start date: December 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

To determine the maximum tolerated dose (MTD) based on the safety and tolerability after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis. To explore the efficacy after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis.

NCT ID: NCT04723303 Active, not recruiting - Dermatomyositis Clinical Trials

Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)

Start date: October 6, 2021
Phase: Early Phase 1
Study type: Interventional

This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.