Clinical trials: Sclerosis, Progressive Systemic
Diffuse Systemic Sclerosis
Fresolimumab In Systemic Sclerosis
The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.
- Trial name
- NCT01284322
- Testing
- Fresolimumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Boston University
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, Cardiac Involvement
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis
Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful…
- Conditions
- Scleroderma, Cardiac Involvement, Autologous Stem Cell Transplantation
- Trial name
- AST-MOMA (NCT01895244)
- Testing
- Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- University Hospital Tuebingen
Scleroderma, Systemic, Scleroderma, Diffuse
Effects of FT011 in Systemic Sclerosis
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
- Trial name
- NCT04647890
- Testing
- FT011
- Where
- 10 sites in Australia, Netherlands and 3 more
- Volunteers
- 30 people
- Sponsor
- Certa Therapeutics
Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
TL1A Inhibition in Systemic Sclerosis-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept In Vitro Study (FIBROSTOP)
Systemic Sclerosis (SSc) is a rare autoimmune connective tissue disease characterized by microvascular injury, immune activation, and progressive fibrosis of the skin and internal organs.
- Conditions
- Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis, Skin Fibrosis
- Trial name
- FIBROSTOP (NCT07642297)
- Testing
- TL1A stimulation and inhibition (in vitro)
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
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 Scleroderma, Diffuse Cutaneous Scleroderma
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased…
- Trial name
- SFDI (NCT07090226)
- Testing
- Spatial-frequency domain imaging (SFDI)
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Boston University
Diffuse Cutaneous Systemic Sclerosis
Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis…
- Trial name
- NCT03198689
- Testing
- Brentuximab Vedotin
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.
- Trial name
- NCT04138485
- Testing
- IgPro10
- Where
- 77 sites in United States, Argentina and 11 more
- Sponsor
- CSL Behring
Diffuse Cutaneous Systemic Sclerosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc).
- Trial name
- RESOLVE-1 (NCT03398837)
- Testing
- Lenabasum 5 mg, Lenabasum 20 mg
- Where
- 74 sites in United States, Australia and 10 more
- Volunteers
- 365 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Scleroderma, Systemic Sclerosis
SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States…
- Trial name
- SPIN-SELF (NCT04246528)
- Testing
- SPIN-SELF Program
- Where
- Canada
- Volunteers
- 169 people
- Sponsor
- Lady Davis Institute
Diffuse Cutaneous Systemic Sclerosis
A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ…
- Trial name
- FREEDOM-3 (NCT05098145)
- Testing
- FCR001
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
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
Scleroderma, Diffuse
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands.
- Trial name
- NCT03831438
- Testing
- AVID200
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bristol-Myers Squibb
Diffuse Cutaneous Systemic Sclerosis
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions.
- Trial name
- BardSSc (NCT06936215)
- Testing
- tab baricitinib 4 mg daily, tab methotrexate 25 mg weekly with folic acid 5 mg weekly
- Where
- Bangladesh
- Volunteers
- 24 people
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Scleroderma, Digital Ulcer
Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
Digital Ulcers (DEs), are painful open sores on the fingers and toes and are due to limited perfusion of blood vessels in patients with Scleroderma.
- Conditions
- Scleroderma, Digital Ulcer, Autoimmune Diseases, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CURE (NCT05168215)
- Where
- Greece
- Volunteers
- 300 people
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Systemic Sclerosis Pulmonary, Pulmonary Hypertension
Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement
Progressive SSc is an entity with limited therapeutic alternatives and with asurvival rate of less than 45% in the first 3 to 5 years.
- Conditions
- Systemic Sclerosis Pulmonary, Pulmonary Hypertension, Pulmonary Fibrosis
- Trial name
- NCT04432545
- Testing
- Mesenchymal Stem Cells from Wharton ́s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ́s jelly
- Where
- Colombia
- Sponsor
- Universidad de la Sabana
Scleroderma
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis.
- Trial name
- TAMER (NCT02370784)
- Testing
- atorvastatin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Robyn T. Domsic, MD, MPH
Diffuse Cutaneous Systemic Sclerosis
Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation…
- Trial name
- NCT05149768
- Testing
- Brentuximab vedotin
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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