Clinical trials: Dermatomyositis, Adult Type
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
DERMATOMYOSITIS OR POLYMYOSITIS
A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis
The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis.
- Trial name
- NCT00533091
- Testing
- MEDI-545
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- MedImmune LLC
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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
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.
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
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
- Trial name
- NCT02466243
- Testing
- JBT-101
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Dermatomyositis
Study of NM8074 in Patients with Dermatomyositis (DM)
This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM).
- Trial name
- NCT06887738
- Testing
- NM8074
- Volunteers
- 8 people
- Sponsor
- NovelMed Therapeutics
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
- Trial name
- NCT02780674
- Testing
- MEDI7734
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Active Dermatomyositis
Safety and Efficacy of BAF312 in Dermatomyositis
This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal…
- Trial name
- NCT02029274
- Testing
- BAF312
- Where
- 9 sites in United States, Czechia and 1 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
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.
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
Dermatomyositis
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
- Trial name
- NCT05192200
- Testing
- Anti-Beta Interferon (PF-06823859)
- Where
- 25 sites in United States, Hungary and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
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
Systemic Lupus Erythematosus, Systemic Sclerosis
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen…
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, Polymyositis
- Trial name
- CASTLE (NCT06347718)
- Testing
- anti-CD19 CAR T cell therapy
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Miltenyi Biomedicine GmbH
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
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
SLE (Systemic Lupus), Sjogren's Syndrome
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
- Conditions
- SLE (Systemic Lupus), Sjogren's Syndrome, Systemic Scleroderma, Dermatomyositis
- Trial name
- NCT06056921
- Testing
- CD19 targeted CAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Dermatomyositis
Trial of IMO-8400 in Adult Patients With Dermatomyositis
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
- Trial name
- 8400-211 (NCT02612857)
- Testing
- IMO-8400 Dose Group 1, IMO-8400 Dose Group 2
- Where
- 20 sites in United States, Hungary and 1 more
- Volunteers
- 30 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen