Clinical trials: Dermatomyositis
Dermatomyositis, Myositis
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants.
- Trial name
- empacific (NCT06284954)
- Testing
- Empasiprubart IV
- Where
- 28 sites in United States, Georgia and 5 more
- Volunteers
- 3 people
- Sponsor
- argenx
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.
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.
Polymyositis, Dermatomyositis
Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis
The efficacy of PN-101 in subjects with polymyositis or dermatomyositis will be evaluated at Week 12 using IMACS-TIS in comparison with the placebo control group.
- Trial name
- NCT07122648
- Testing
- PN-101
- Where
- 5 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Paean Biotechnology Inc.
Dermatomyositis, Juvenile, Dermatomyositis
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)
This study is an open-label, single-arm, dose-escalation trial primarily designed to evaluate the safety and efficacy of a universal CAR-T cell therapy targeting CD19 in the treatment of patients with RJDM.
- Trial name
- NCT06686524
- Testing
- Anti-CD19 UCAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Trial name
- NCT07184450
- Testing
- BCMA/CD70-targetd CAR-T
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Idiopathic Inflammatory Myositis (IIM), DERMATOMYOSITIS OR POLYMYOSITIS
Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)
The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell (ULSC) product performs when treating Dermatomyositis/Polymyositis (DM/PM), also known as idiopathic inflammatory myopathy (IIM) in…
- Trial name
- IIMPACT (NCT07160205)
- Testing
- ULSC (1.5 x 10^8 cells/dose)
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Restem, LLC.
Polymyositis, Dermatomyositis
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength…
- Trial name
- NCT00335985
- Testing
- GB-0998
- Where
- Japan
- Volunteers
- 26 people
- Sponsor
- Japan Blood Products Organization
Polymyositis, Dermatomyositis
Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis
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.
- Trial name
- NCT04976140
- Testing
- PN-101
- Where
- 3 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Paean Biotechnology Inc.
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
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
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Dermatomyositis
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis.
- Trial name
- DETERMINE (NCT03813160)
- Testing
- Lenabasum 20 mg, Lenabasum 5 mg
- Where
- 54 sites in United States, Bulgaria and 11 more
- Volunteers
- 176 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Dermatomyositis
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis…
- Trial name
- GALARISSO (NCT05695950)
- Testing
- GLPG3667
- Where
- 54 sites in United States, Argentina and 13 more
- Volunteers
- 40 people
- Sponsor
- Lakefront Biotherapeutics NV
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
Polymyositis, Dermatomyositis
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with…
- Trial name
- JASMINE (NCT06455449)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 237 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
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
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
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics