Clinical trials: Immune Mediated Inflammatory Diseases, active
IgG4 Related Disease, Systemic Sclerosis (SSc)
Nebulized UC-EVs for Recurrent or Refractory IMIDs With Lung Involvement
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs.
- Trial name
- NCT07806045
- Testing
- nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Qiubai Li
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Vaccination Varicella-zoster Virus, Immune-mediated Systemic Inflammatory Diseases
Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
Patients with immune-mediated systemic inflammatory diseases (IMID) are at increased risk of shingles due to treatment-induced immunosuppression.
- Trial name
- ZONAMID (NCT07047053)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Telemedicine, Telehealth
Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)
The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to…
- Conditions
- Telemedicine, Telehealth, eHealth, Rheumatic Diseases
- Trial name
- IMIDOC (NCT06273306)
- Testing
- IMIDOC
- Volunteers
- 360 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
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
Autoimmune Disorders
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.
- Trial name
- SUMMIT (NCT07103746)
- Testing
- Ublituximab
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga.
- Conditions
- Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy
- Trial name
- NCT04153422
- Testing
- Panzyga IVIG
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Health
Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD)
Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.
The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation…
- Conditions
- Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), Ulcerative Colitis (UC)
- Trial name
- DIETA-MICIREUM (NCT06862843)
- Testing
- Collecting questionnaires and biological samples
- Where
- 4 sites in Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Meyer Children's Hospital IRCCS
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
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
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
Long COVID
Clinical Trial on a Natural Compound to Improve Chronic Inflammation After SARS-CoV-2 Infection
A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the…
- Trial name
- NUTRACOVID (NCT07397910)
- Testing
- Experimental Product, Physical exercise, No Physical Exercise
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Universidad Católica San Antonio de Murcia
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD)
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of…
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Trial name
- NCT07526493
- Testing
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Tongji Hospital
Cardiovascular Diseases, Immune-Mediated Inflammatory Diseases
UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study
The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and…
- Trial name
- CARDIO-IMID (NCT06478277)
- Where
- 2 sites in United Kingdom
- Volunteers
- 600 people
- Sponsor
- University of Manchester
Pericarditis, Tako-TSUBO Cardiomyopathy
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with…
- Conditions
- Pericarditis, Tako-TSUBO Cardiomyopathy, Myocarditis, Inflammatory Cardiomyopathies
- Trial name
- INFLAME-BANK (NCT07737470)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery. Participants will be randomly assigned to one of two groups.
- Conditions
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer, Toll-Like Receptors
- Trial name
- SPSIP-TLR4 (NCT07843212)
- Testing
- Serratus posterior superior intercostal plane block
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mucahide Emine Fidancı Kuas
Cardiovascular Diseases, Rheumatologic Disease
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
The researchers would like to know more about cardiovascular abnormalities in patients with immune-mediated inflammatory diseases (IMID) and with the aim to provide new biomarkers (clinical, blood, imaging) for early diagnosis…
- Trial name
- GM CARDIO-IMID (NCT06600737)
- Where
- United Kingdom
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- University of Manchester
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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
Psoriasis, Atopic Dermatitis
LANDSCAPE: Demographics and Treatment Patterns of Patients With Immune-Mediated Inflammatory Skin Diseases in Italian Clinical Practice
This multicenter retrospective observational registry study will collect existing clinical data from Italian centers to describe epidemiology, treatment patterns, clinical evolution, safety, and comorbidities in patients aged 12…
- Conditions
- Psoriasis, Atopic Dermatitis, Vitiligo, Alopecia Areata
- Trial name
- LANDSCAPE (NCT07336641)
- Testing
- Conventional Systemic Therapies, Biologic Therapies
- Where
- Italy
- Volunteers
- 20,000 people
- Sponsor
- Fondazione ISIDE