Clinical trials: Anti-Synthetase Syndrome
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 17 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
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
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
Anti-Synthetase Syndrome, Interstitial Lung Disease (ILD)
A Randomized, Double-Blind, Placebo-Controlled Trial of Fufei Huazhuo Tongluo Formula Combined With Standardized Medicine in Patients With Anti-Synthetase Syndrome-Associated Interstitial Lung Disease
The goal of this clinical trial is to learn if the traditional Chinese medicine formula "FuFei HuaZhuo TongLuo Granule" combined with standardized western medicine works to treat anti-synthetase syndrome-associated interstitial…
- Trial name
- NCT07836790
- Testing
- FuFei HuaZhuo TongLuo Granule
- Where
- China
- Volunteers
- 54 people
- Sponsor
- First People's Hospital of Hangzhou
Myositis, Myasthenia Gravis
Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis
The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis (MG) is immunosuppressive therapy, usually beginning with corticosteroids.
- Trial name
- FORCE (NCT00774462)
- Testing
- Rituximab
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
IBM, IIM
MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)
Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities.
- Conditions
- IBM, IIM, Myositis, Inflammatory Myopathy
- Trial name
- MIHRA-PRISMS (NCT07374107)
- Testing
- No intervention - qualitative and mixed methods investigations
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Myositis International Health & Research Collaborative Alliance Foundation
Antisynthetase Syndrome, Tocilizumab
Tocilizumab in Refractory ASS-ILD
Refractory anti-synthetase syndrome-associated interstitial lung disease (ASyS-ILD) lacks targeted therapy. Interleukin-6 drives both inflammation and fibrosis.
- Trial name
- NCT07662265
- Testing
- Tociliuzumab
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Hu Yinan
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.
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
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
Myositis, Dermatomyositis
Environmental Risk Factors for the Anti-synthetase Syndrome
Background: Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors.
- Conditions
- Myositis, Dermatomyositis, Polymyositis, Juvenile Dermatomyositis
- Trial name
- NCT01276470
- Where
- 8 sites in United States
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Antisynthetase Syndrome
Association Between Cancer and Anti-synthetase Syndrome
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might…
- Trial name
- NCT04941547
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France