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Myositis, Inclusion Body clinical trials

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NCT ID: NCT06450886 Not yet recruiting - Clinical trials for Inclusion Body Myositis (IBM)

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis

Start date: September 23, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and: - Have completed the Part 2 (Multiple Ascending Dose [MAD]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR - Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.

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: NCT04907162 Completed - Healthy Clinical Trials

Musculoskeletal Nociceptive Pain in Participants With Neuromuscular Disorders

Start date: April 15, 2021
Phase:
Study type: Observational

The primary aim is to characterize the prevalence, severity and quality of musculoskeletal nociceptive pain in adult patients with neuromuscular disorders (NMD). The secondary objectives are to evaluate whether severity and distribution of muscle pain is associated with muscle function, and to assess whether muscle pain is associated with alterations of muscle elasticity and muscle stiffness. Results of patients with neuromuscular disorders will be compared to age- and gender-matched healthy volunteers. Approx. 70 patients with neuromuscular disorders and 20 healthy volunteers will be enrolled, including patients with the following neuromuscular disorders: histologically confirmed inclusion body myositis (IBM), genetically confirmed late-onset Pompe disease (LOPD), genetically confirmed spinal muscular atrophy type 3 (SMA3), genetically confirmed facio-scapulo-humeral muscle dystrophy (FSHD), genetically confirmed myotonic dystrophy type 1 or type 2 (DM1, DM2). The duration of patient recruitment will be around 12 months.

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.