Clinical trials: Scleroderma, Diffuse, open to volunteers
Systemic Sclerosis
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life.
- Trial name
- ADUSE (NCT04356755)
- Testing
- AdMSC
- Where
- 7 sites in France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Toulouse
Systemic Sclerosis (SSc)
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial.
- Trial name
- ASScERT-QoL (NCT06675344)
- Testing
- Apollo Neuro Device
- Where
- 4 sites in United States
- Volunteers
- 160 people
- Sponsor
- Robyn T. Domsic, MD, MPH
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients…
- Conditions
- Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07085676
- Testing
- HBI0101 CART
- Where
- Israel
- Volunteers
- 120 people
- Sponsor
- Polina Stepensky
Scleroderma, Localized, Morphea
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country.
- Conditions
- Scleroderma, Localized, Morphea, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Circumscribed
- Trial name
- MAC (NCT01808937)
- Testing
- Morphea
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Constipation, Bloating
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic…
- Trial name
- NCT06827977
- Testing
- PRIM-DJ2727
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- The University of Texas Health Science Center, Houston
SLE, Systemic Sclerosis
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS…
- Conditions
- SLE, Systemic Sclerosis, IIM, NMOSD
- Trial name
- NCT06775912
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Connective Tissue Diseases, Interstitial Lung Disease
Connective Tissue Diseases and Lung Manifestations
Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD)…
- Conditions
- Connective Tissue Diseases, Interstitial Lung Disease, Systemic Sclerosis
- Trial name
- Colipris (NCT04095351)
- Testing
- Pulmonary function test, Imaging, Blood sampling
- Where
- Austria
- Volunteers
- 120 people
- Sponsor
- Medical University Innsbruck
Systemic Sclerosis (SSc), Calcinosis Cutis
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments…
- Trial name
- NCT07228429
- Testing
- Sodium Thiosulfate (STS), Sodium Thiosulfate Injection
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Yale University
Systemic Sclerosis, Digital Ulcer
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.
- Trial name
- MANUS (NCT03211793)
- Testing
- Mesenchymal stromal cells
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- UMC Utrecht
Eosinophilic Fasciitis
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
Eosinophilic fasciitis is a connective tissue disorder characterized by inflammation of the muscle fasciae, which is very rare in children.
- Trial name
- NCT07348263
- Where
- 15 sites in United States, Croatia and 9 more
- Volunteers
- 20 people
- Sponsor
- Meyer Children's Hospital IRCCS
SLE (Systemic Lupus), Systemic Sclerosis
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Sclerosis, Systemic, Mesenchymal Stem Cells
Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).
- Trial name
- CARE-SSc (NCT04356287)
- Testing
- UCMSC
- Where
- Canada
- Volunteers
- 18 people
- Sponsor
- Marie Hudson, MD
Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases
This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune…
- Conditions
- Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjogren's Syndrome
- Trial name
- NCT06614270
- Testing
- Anti-CD19 IL-10/IL15 CAR-NK
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD).
- Trial name
- BLISSc-ILD (NCT05878717)
- Testing
- Belimumab
- Where
- 134 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Systemic Sclerosis (SSc), Digital Ulcer
Hand Disability In Systemic Sclerosis - Digital Ulcers
The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.
- Trial name
- NCT06658470
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- Pamukkale University
Systemic Sclerosis, Diffuse Sclerosis Systemic
Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment…
- Conditions
- Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
- Trial name
- SSc (NCT03630211)
- Testing
- Cyclophosphamide, Mesna, Rituximab
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paul Szabolcs
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary Hypertension, Systemic Sclerosis (SSc)
Multicenter Study on the Development of Pulmonary Arterial Hypertension Screening Models Based on Artificial Intelligence for Patients With Systemic Sclerosis
Pulmonary Arterial Hypertension (PAH) is a rare and severe condition that can be associated with Systemic Sclerosis (SSc), significantly worsening the prognosis of the latter disease.
- Conditions
- Pulmonary Hypertension, Systemic Sclerosis (SSc), Systemic Sclerosis-Associated PAH
- Trial name
- ARENAS (NCT07236970)
- Where
- 5 sites in Spain
- Volunteers
- 350 people
- Sponsor
- Alejandro Cruz Utrilla
Systemic Sclerosis (SSc), Pulmonary Arterial Hypertension (PAH)
Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
The goal of this observational pilot trial is to evaluate the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH).
- Conditions
- Systemic Sclerosis (SSc), Pulmonary Arterial Hypertension (PAH), Home Monitoring Follow-up
- Trial name
- Nor-SScCare (NCT06865118)
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Oslo University Hospital