Clinical trials: Diffuse Cutaneous Systemic Sclerosis
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.
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.
Scleroderma, Keloids
UVA1 Light for Treatment of Scleroderma and Similar Conditions
The purpose of this investigation is to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1.
- Conditions
- Scleroderma, Keloids, Other Fibrosing Conditions
- Trial name
- NCT00476801
- Testing
- German manufactured UVA1 light emitting device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Michigan
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
Diffuse Cutaneous Systemic Sclerosis
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- NCT04166552
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 36 people
- Sponsor
- Emerald Health Pharmaceuticals
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines…
- Trial name
- NCT05626751
- Testing
- HZN-825
- Where
- 65 sites in United States, Argentina and 13 more
- Volunteers
- 174 people
- Sponsor
- Amgen
Scleroderma, Diffuse, Scleroderma, Systemic
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options.
- Trial name
- NCT00442611
- Testing
- Abatacept
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stanford University
Systemic Sclerosis, Fibromyalgia
Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis
Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction…
- Trial name
- NCT04411498
- Testing
- Fibromyalgia diagnosis in patients with SSc
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Antalya Training and Research Hospital
Scleroderma
Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma
Scleroderma is a complex connective tissue disease involving three interconnected pathophysiological axes: vascular hyperactivity and remodelling, immune system dysfunction and over-activation of fibroblasts at the origin of the…
- Trial name
- TRANSCLERO (NCT07256418)
- Testing
- Skin samples, Analysis of fibroblasts
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon