Clinical trials: Idiopathic Inflammatory Myositis (IIM)
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
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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
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
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
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Sjogrens Disease, Idiopathic Inflammatory Myopathy (IIM)
OM336 in Seropositive Autoimmune Diseases
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.
- Trial name
- NCT07229144
- Testing
- OM336
- Where
- New Zealand
- Volunteers
- 39 people
- Sponsor
- Lakefront Biotherapeutics West LLC
Idiopathic Inflammatory Myopathies
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
- Trial name
- NCT06665256
- Testing
- Rapcabtagene autoleucel, Active Comparator Option
- Where
- 68 sites in United States, Australia and 13 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Active Idiopathic Inflammatory Myopathy, Myositis
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA (NCT05523167)
- Testing
- EFG PH20 SC, PBO
- Where
- 202 sites in United States, Argentina and 34 more
- Volunteers
- 265 people
- Sponsor
- argenx
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
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Idiopathic Inflammatory Myopathy, Dermatomyositis
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
- Conditions
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- NCT06154252
- Testing
- CABA-201 following preconditioning with fludarabine and cyclophosphamide
- Where
- 38 sites in United States, Germany and 2 more
- Volunteers
- 74 people
- Sponsor
- Cabaletta Bio
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
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM)
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Trial name
- NCT07331272
- Testing
- LUCAR-G79D T cells
- Where
- 5 sites in China
- Volunteers
- 38 people
- Sponsor
- Nanjing Legend Biotech Co.
Dermatomyositis, Polymyositis
Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")
- Conditions
- Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies
- Trial name
- FROG (NCT05833711)
- Testing
- Froniglutide
- Where
- South Korea
- Volunteers
- 39 people
- Sponsor
- Immunoforge Co. Ltd.
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
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, Idiopathic Inflammatory Myopathies
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: The study duration will be a minimum of 180…
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- TITAN (NCT06916806)
- Testing
- AZD5492
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 72 people
- Sponsor
- AstraZeneca