Clinical trials: Diffuse Scleroderma
Systemic Sclerosis
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Sclerosis, Raynaud Phenomena
The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )
This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to…
- Trial name
- NCT03059979
- Testing
- Methylprednisolone, sodium chloride
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Relapsed/Refractory Systemic Lupus Erythematosus, Relapsed/Refractory Systemic Sclerosis
Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases
Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells.
- Conditions
- Relapsed/Refractory Systemic Lupus Erythematosus, Relapsed/Refractory Systemic Sclerosis, Relapsed/Refractory Idiopathic Inflammatory Myopathies, Relapsed/Refractory sjögren's Syndrome
- Trial name
- NCT07361094
- Testing
- Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy
- Where
- China
- Sponsor
- Beijing Boren Hospital
Digital Ulcers
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration.
- Trial name
- DUAL-2 (NCT01474122)
- Testing
- Macitentan 3 mg, Macitentan 10 mg
- Volunteers
- 265 people
- Sponsor
- Actelion
Autoimmune Diseases, Systemic Lupus Erythematosus
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome
- Trial name
- NCT07246096
- Testing
- anti-CD19/BCMA U CAR T cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Changhai Hospital
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Systemic Sclerosis
Chest CT Biomarkers as Prognostic Predictors in SSc-ILD
The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival…
- Trial name
- NCT06472362
- Testing
- HRCT biomarkers
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in…
- Conditions
- Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases, Recurrent or Refractory Systemic Sclerosis, Recurrent or Refractory Idiopathic Inflammatory Myopathy
- Trial name
- NCT07339540
- Testing
- V001-BCMA
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Tongji Hospital
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories
Pirfenidone, Connective Tissue Diseases
Immunosuppressant Combined With Pirfenidone in CTD-ILD
A prospective cohort study was used to observe the efficacy and safety of different immunosuppressive agents with/wo pirfenidone on CTD-ILD patients in Qilu Hospital of Shandong University for 36 months.The main research…
- Conditions
- Pirfenidone, Connective Tissue Diseases, Interstitial Lung Disease
- Trial name
- NCT04928586
- Testing
- Pirfenidone, DMARDs
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Qilu Hospital of Shandong University
Systemic Sclerosis, Raynaud Disease
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
OBJECTIVES: I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
- Trial name
- NCT00004786
- Testing
- iloprost
- Volunteers
- 200 people
- Sponsor
- National Center for Research Resources (NCRR)
Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.
- Trial name
- NCT07167537
- Testing
- OL-CD19-GDT
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Beijing GoBroad Hospital
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
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic…
- Trial name
- NCT06375005
- Testing
- Telitacicept, Mycophenolate Mofetil
- Where
- 9 sites in China
- Volunteers
- 38 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Systemic Scleroderma
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active…
- Trial name
- LIBERIUS (NCT05726630)
- Testing
- Divozilimab
- Where
- 3 sites in Russia
- Volunteers
- 152 people
- Sponsor
- Biocad
Systemic Sclerosis
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Primary Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT01651143
- Testing
- SAR100842
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
Dry Eye, Sjogren's Syndrome
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort.
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Trial name
- NCT01393132
- Testing
- Thymosin Beta 4 eye drops, Vehicle Control
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Michigan Cornea Consultants, PC
Raynaud's Syndrome
Botulinum Toxin in the Treatment of Raynaud's
The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers…
- Trial name
- NCT01233999
- Testing
- botulinum toxin A
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Scleroderma
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and…
- Trial name
- NCT04588714
- Testing
- Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan
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