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Inclusion Body Myositis clinical trials

View clinical trials related to Inclusion Body Myositis.

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NCT ID: NCT06153108 Recruiting - Clinical trials for Inclusion Body Myositis

Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Start date: November 16, 2023
Phase:
Study type: Observational

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, we will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

NCT ID: NCT05890833 Recruiting - Myasthenia Gravis Clinical Trials

The Risk of Falls Index for Patients With Neuromuscular Disorders

Start date: September 1, 2023
Phase:
Study type: Observational

The combination of short quantitatively assessing muscular function and balance in combination with short clinical scores, can be a new valid approach to evaluate the patient risk of fall and help to create a quick checkup test to prescribe an appropriate assistive device. The primary goal of this project is to provide a short battery of clinical assessments used to determine risk of falling for patients with neuromuscular diseases (NMD) based on correlation between clinical assessments between two groups of NMD patients and scales used to assess risk of falling for patients.

NCT ID: NCT05721573 Active, not recruiting - Clinical trials for Inclusion Body Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Start date: February 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

NCT ID: NCT05272969 Recruiting - Clinical trials for Pompe Disease (Late-onset)

Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe Disease

Start date: March 31, 2022
Phase:
Study type: Observational

The primary aim of this nationwide, explorative, cross-sectional study in Germany is to characterize the prevalence, severity and quality of musculoskeletal pain in adult patients with late-onset Pompe disease (LOPD). The secondary objectives are to evaluate whether muscle pain is associated with muscle function, to assess whether muscle pain is associated with alterations of muscle tissue, and whether vitamin D metabolism and polymorphisms of ACE and ACTN3 genes may contribute to an increased level of perceived musculoskeletal pain. In a second step, exome sequencing of genes associated with musculoskeletal pain will be analyzed. Results of LOPD patients will be compared to patients with neuromuscular disorders with a similar distribution of muscle weakness and/or musculoskeletal pain.

NCT ID: NCT05046821 Active, not recruiting - Clinical trials for Inclusion Body Myositis

Sporadic Inclusion Body Myositis Natural History Study

INSPIRE-IBM
Start date: October 11, 2021
Phase:
Study type: Observational

This is a prospective natural history study on patients with clinically defined sIBM. Participants will be assessed every 6 months over two years (five visits total). We will include 150 participants, enrolled across 13 sites, with sporadic IBM, diagnosed according to established criteria.

NCT ID: NCT05032131 Recruiting - Clinical trials for Inclusion Body Myositis

Cell Therapy for IBM by Muscle Injection of ADSVF

ADSVF-in-IBM
Start date: February 1, 2023
Phase: Phase 1
Study type: Interventional

Inclusion Body Myositis is a slowly but disabling myopathy, the most frequent in patients over 50 years old. No treatments (in particular immunosuppressive) are known to be efficient. Autologous uncultured adipose-derived stromal vascular fraction (ADSVF) is recognized as an easily accessible (by a standard liposuction to obtain adipose tissue, from which ADSVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. The purpose of our ADSVF in IBM phase I trial is to evaluate, for the first time in human diseased muscle, first the tolerance of autologous ADSVF cells locally injected in affected forearm muscles and second their capability to repair those muscles. With always the goals of tolerance first and second muscle repair, we will recruit in parallel two groups of IBM patients: the first treated by sirolimus since at least 6 months (but still disabled) and the second currently (for at least 3 months) without specific treatment for inclusion myositis.

NCT ID: NCT04975841 Active, not recruiting - Clinical trials for Inclusion Body Myositis

Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This is an open-label, single arm study evaluating the safety for patients with Inclusion Body Myositis. A total of 9 subjects will be enrolled in the study. Subjects will be randomized to Part 1 or Part 2 of the study in blocks of 3 every 3 months. Stem cell injections will be given in the forearm and thigh on either the left or right side of the body, depending on which side meets criteria. The overall goal of this pilot study is to test the safety of adipose derived regenerative cells in patients with Inclusion Body Myositis. If determined safe, this trial could lead to larger Phase II trials. While this specific trial's primary endpoint is safety, it our ultimate hope that ADRC injections into the forearm and thigh of IBM patients will slow, stabilize, or even reverse the progression of muscle weakness in patients with IBM.

NCT ID: NCT04789070 Recruiting - Clinical trials for Inclusion Body Myositis

Phase III Trial of Sirolimus in IBM

Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The hypothesis is that Sirolimus, (Rapamycin (R)) which is currently used in organ transplantation and works by blocking the activity of T effector cells but preserving T regulatory cells, as well as by inducing autophagy (protein degradation), will be effective in IBM to slow or stabilize disease progression, helping to maintain patient function and independence. This phase III trial will confirm pilot data showing statistically significant clinical outcomes.

NCT ID: NCT04659031 Active, not recruiting - Clinical trials for Inclusion Body Myositis

A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)

Start date: May 25, 2021
Phase: Phase 1
Study type: Interventional

An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).

NCT ID: NCT04421677 Completed - Clinical trials for Inclusion Body Myositis

Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis

Start date: August 20, 2020
Phase: Phase 1
Study type: Interventional

This is a pilot study (phase 1 clinical trial) to evaluate the safety and tolerability of phenylbutyrate in IBM. In this open label study, 10 patients with sporadic inclusion body myositis will be treated with phenylbutyrate (3 gm twice daily) for 3 months. There will be a run-in period, during which certain biomarkers will be measured at baseline and at the end of the run-in period in addition to final measurement at the end of the treatment period.