Clinical trials: Myositis
Myositis Associated Interstitial Lund Disease (MA-ILD)
Myositis Interstitial Lung Disease Nintedanib Trial
This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
- Trial name
- MINT (NCT05799755)
- Testing
- Nintedanib, Standard of Care
- Where
- 10 sites in United States
- Volunteers
- 62 people
- Sponsor
- Rohit Aggarwal, MD
Inclusion Body Myositis
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
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
- Trial name
- NCT05721573
- Testing
- ABC008
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 272 people
- Sponsor
- Abcuro, Inc.
Dermatomyositis, Polymyositis
Study of M5049 in DM and PM Participants (NEPTUNIA)
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.
- Trial name
- NCT05650567
- Testing
- M5049 dose
- Where
- 31 sites in United States, Czechia and 5 more
- Volunteers
- 20 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Idiopathic Inflammatory Myositis
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1.
- Trial name
- NCT05669014
- Testing
- Daxdilimab
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Amgen
Polymyositis, Dermatomyositis
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients…
- Trial name
- PRESIDIO (NCT04033926)
- Testing
- KZR-616
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 25 people
- Sponsor
- Kezar Life Sciences, Inc.
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, Inc.
Myositis, Inflammatory
Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions
Background: Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation.
- Conditions
- Myositis, Inflammatory, Rheumatoid Arthritis, Healthy Volunteers
- Trial name
- NCT03912428
- Testing
- 11C-MC1, Celecoxib, [11C]ER176
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- National Institute of Mental Health (NIMH)
Fibrodysplasia Ossificans Progressiva (FOP)
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP.
- Trial name
- PIVOINE (NCT05027802)
- Testing
- Palovarotene
- Where
- 13 sites in United States, Argentina and 8 more
- Volunteers
- 61 people
- Sponsor
- Ipsen
Fibrodysplasia Ossificans Progressiva
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue…
- Trial name
- NCT02279095
- Testing
- Palovarotene dose level 1, Palovarotene dose level 2, Palovarotene dose level 3
- Where
- 8 sites in United States, Argentina and 3 more
- Volunteers
- 58 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Myositis, Interstitial Lung Disease
Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.
- Trial name
- ATtackMy-ILD (NCT03215927)
- Testing
- Abatacept
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Rohit Aggarwal, MD
Dermatomyositis, Idiopathic Inflammatory Myopathies
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis.
- Trial name
- NCT03267277
- Testing
- Sodium Thiosulfate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Myositis
Belimumab in Idiopathic Inflammatory Myositis
The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care.
- Trial name
- BIM (NCT02347891)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Northwell Health
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to…
- Trial name
- MOVE (NCT03312634)
- Testing
- Palovarotene
- Where
- 16 sites in United States, Argentina and 9 more
- Volunteers
- 107 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Polymyositis, Dermatomyositis
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
- Conditions
- Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis
- Trial name
- NCT02971683
- Testing
- Abatacept subcutaneous
- Where
- 79 sites in United States, Australia and 9 more
- Volunteers
- 149 people
- Sponsor
- Bristol-Myers Squibb
Inclusion Body Myositis
Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial
A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)
- Trial name
- NCT04049097
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 121 people
- Sponsor
- ZevraDenmark
Inclusion Body Myositis
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.
- Trial name
- NCT02753530
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 152 people
- Sponsor
- ZevraDenmark
Fibrodysplasia Ossificans Progressiva
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3).
- Trial name
- LUMINA-1 (NCT03188666)
- Testing
- REGN2477
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 44 people
- Sponsor
- Regeneron Pharmaceuticals
Dermatomyositis
Abatacept in Juvenile Dermatomyositis
The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in 10 patients seven years of age and older with refractory JDM.
- Trial name
- AID (NCT02594735)
- Testing
- Abatacept
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- George Washington University
Local Anesthetic Complication, Local Anesthetic Drug Adverse Reaction
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA).
- Trial name
- NCT04821245
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Benaroya Research Institute
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.