Clinical trials: Systemic Scleroderma, open to volunteers
Systemic Sclerosis (SSc), Dermatomyositis
Intralesional Injection of STS in Treatment of Calcinosis
The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc)…
- Conditions
- Systemic Sclerosis (SSc), Dermatomyositis, Mixed Connective Tissue Disease (MCTD), Calcinosis
- Trial name
- STSINJ (NCT06672822)
- Testing
- Sodium Thiosulfate (STS)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Robyn T. Domsic, MD, MPH
Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE)
Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases
The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat autoimmune diseases, when compared to normal saline (given to placebo group).
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, Ankylosing Spondylitis (AS)
- Trial name
- MSCs in AD (NCT06888973)
- Testing
- Mesenchymal Stem Cells
- Where
- 2 sites in Pakistan
- Volunteers
- 200 people
- Sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
Interstitial Lung Disease Due to Systemic Disease, Scleroderma
Platform Clinical Study for Conquering Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with…
- Trial name
- CONQUEST (NCT06195072)
- Testing
- Amlitelimab, BI 1015550 (Nerandomilast)
- Where
- 34 sites in United States
- Volunteers
- 400 people
- Sponsor
- Scleroderma Research Foundation, Inc.
Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis
YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases
This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed/refractory autoimmune diseases, including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis, Idiopathic Inflammatory Myopathies (IIMs), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07439029
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Fudan University
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator…
- Trial name
- ROSY-S (NCT07691970)
- Testing
- Anifrolumab
- Where
- 153 sites in United States, Argentina and 33 more
- Volunteers
- 1,072 people
- Sponsor
- AstraZeneca
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
Systemic Sclerosis (SSc), Scleroderma
Patients Diagnosed With Scleroderma: Physical Performance and Functionality
Physical functionality and performance are important for individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial…
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized
- Trial name
- NCT07183072
- Testing
- Questionnaire and functionality application for child and adult scleroderma patients
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Rheumatoid Arthritis, Dermatomyositis
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases.
- Conditions
- Rheumatoid Arthritis, Dermatomyositis, Systemic Lupus Erythematosus, Systemic Sclerosis
- Trial name
- NCT07558850
- Testing
- anti-CD19/BCMA-UCAR-T cells
- Where
- China
- Volunteers
- 72 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Scleroderma, Systemic Sclerosis
Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis.
- Trial name
- SCLERESO (NCT04265144)
- Testing
- Blood samples, Biopsy, Bronchoalveolar samples
- Where
- France
- Volunteers
- 500 people
- Sponsor
- University Hospital, Bordeaux
Systemic Scleroderma
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
Orofacial manifestations and microstomia are a frequent complication in systemic sclerosis (SSc) with a major impact on oral hygiene, dental care and quality of life.
- Trial name
- A-MUSE (NCT07326033)
- Testing
- AdMSC
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Toulouse
Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually…
- Trial name
- RE-WARM (NCT07748000)
- Testing
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm, LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Volunteers
- 75 people
- Sponsor
- Liquidia Technologies, Inc.
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.
Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension
Hormonal, Metabolic, and Signaling Interactions in PAH
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease.
- Conditions
- Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Scleroderma Associated Pulmonary Arterial Hypertension, Appetite Suppressant Associate PAH
- Trial name
- NCT01884051
- Where
- United States
- Volunteers
- 1,899 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Autoimmune Disease, Crohn Disease
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in…
- Conditions
- Autoimmune Disease, Crohn Disease, Dermatomyositis, Hematopoietic and Lymphoid Cell Neoplasm
- Trial name
- NCT03816345
- Testing
- Biospecimen Collection, Cabozantinib, Fluoropyrimidine
- Where
- 52 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- National Cancer Institute (NCI)
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases.
- Trial name
- Botox SSc-RP (NCT07759557)
- Testing
- Botulinum toxin A via microneedle, Control (Normal saline)
- Volunteers
- 72 people
- Sponsor
- Khon Kaen University
Systemic Sclerosis and Systemic Lupus Erythematous
Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment. Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.
- Trial name
- NCT06287125
- Testing
- Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
- Volunteers
- 95 people
- Sponsor
- Assiut University
Systemic Sclerosis (SSc), GERD (Gastroesophageal Reflux Disease)
PPI Refractory - GERD Mechanisms in Systemic Sclerosis
The goal of this observational study is to learn about the mechanisms of gastroesophageal reflux disease (GERD) in patients with systemic sclerosis (SSc) who continue to experience reflux symptoms despite treatment with proton…
- Trial name
- NCT07022912
- Testing
- educational healthcare intervention, Objective assessment of GI motility, Evaluation of GERD severity
- Volunteers
- 147 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris