Clinical trials: Inflammatory Myopathy
Fibrodysplasia Ossificans Progressiva
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO).
- Trial name
- FALKON (NCT05039515)
- Testing
- IPN60130
- Where
- 25 sites in United States, Argentina and 12 more
- Volunteers
- 113 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Idiopathic Inflammatory Myopathies
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis.
- Trial name
- VERANDA™-IIM (NCT07789015)
- Testing
- Nerandomilast
- Where
- 150 sites in United States, Argentina and 22 more
- Volunteers
- 270 people
- Sponsor
- Boehringer Ingelheim
Myositis
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM).
- Trial name
- NCT05895786
- Testing
- PF-06823859
- Where
- 138 sites in United States, Argentina and 18 more
- Volunteers
- 318 people
- Sponsor
- Pfizer
Healthy
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress.
- Trial name
- NCT01150526
- Testing
- CaHMB, HMB Free Acid Gel
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Metabolic Technologies Inc.
Polymyositis, Dermatomyositis
A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or…
- Trial name
- NCT03981744
- Testing
- Ustekinumab 6 mg/kg, Ustekinumab 90 mg
- Where
- 32 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Janssen Pharmaceutical K.K.
Inflammatory Myopathy
BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
This single-arm, open-label, phase I trial evaluates the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with refractory Idiopathic inflammatory myopathy (IIM).
- Trial name
- NCT07715136
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR-T
- Where
- China
- Volunteers
- 10 people
- Sponsor
- iCell Gene Therapeutics
Sporadic Inclusion Body Myositis
Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis
The primary objective of the study is to evaluate the efficacy of REGN2477+REGN1033 in combination on total lean mass, as measured by Dual-energy X-ray absorptiometry (DXA) in patients with sporadic inclusion body myositis…
- Trial name
- NCT03710941
- Testing
- REGN2477+REGN1033
- Sponsor
- Regeneron Pharmaceuticals
Dermatomyositis, Polymyositis
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]).
- Trial name
- NCT06698796
- Testing
- Dazukibart
- Where
- 26 sites in United States, Argentina and 10 more
- Volunteers
- 211 people
- Sponsor
- Pfizer
Myositis
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
- Trial name
- SPIREA (NCT05379634)
- Testing
- Nipocalimab, Glucocorticoids
- Where
- 57 sites in United States, Canada and 11 more
- Volunteers
- 36 people
- Sponsor
- Janssen Research & Development, LLC
Fibrodysplasia Ossificans Progressiva (FOP)
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
The objective of this Expanded Access Program (EAP) is to provide garetosmab to adult patients with Fibrodysplasia Ossificans Progressiva (FOP), including patients who have completed the double-blind treatment period of the…
- Trial name
- NCT07301450
- Testing
- Garetosmab
- Sponsor
- Regeneron Pharmaceuticals
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.
Polymyalgia Rheumatica, Inflammatory Diseases
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety…
- Trial name
- NCT01364389
- Testing
- AIN457, ACZ885, Prednisone
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Dermatomyositis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM).
- Trial name
- RECLAIIM (NCT04044690)
- Testing
- human immunoglobulin G
- Where
- 76 sites in United States, Argentina and 12 more
- Volunteers
- 134 people
- Sponsor
- CSL Behring
Dermatomyositis
Study of IFN-K in Dermatomyositis
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis
- Trial name
- NCT02980198
- Testing
- IFN-Kinoid, ISA 51
- Where
- 8 sites in France, Germany and 2 more
- Sponsor
- Neovacs
Dermatomyositis
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants…
- Trial name
- NCT04999020
- Testing
- Ravulizumab
- Where
- 111 sites in United States, Australia and 11 more
- Volunteers
- 38 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Critical Illness, Acute Kidney Injury
Collective Accuryn Physiologic Signals and Signatures
The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device.
- Conditions
- Critical Illness, Acute Kidney Injury, Sepsis, Septic Shock
- Trial name
- CAPSS (NCT03817281)
- Testing
- Accuryn Monitoring System
- Where
- United States
- Sponsor
- Potrero Medical
Juvenile Dermatomyositis
Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis
This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis (RJDM).The experiment was divided into two phases: dose exploration (Part A) and…
- Trial name
- NCT06569472
- Testing
- CD19-targetd CAR-T
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Myositis, Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
- Conditions
- Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA+ (NCT05979441)
- Testing
- Efgartigimod PH20 SC
- Where
- 92 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- argenx