Clinical trials: Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
- Trial name
- ASSET (NCT02161406)
- Testing
- Abatacept
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 88 people
- Sponsor
- Dinesh Khanna, MD, MS
Scleroderma
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.
- Trial name
- NCT02588625
- Testing
- BMS-986020
- Where
- 27 sites in United States, Canada and 2 more
- Sponsor
- Bristol-Myers Squibb
Systemic Sclerosis
MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis
To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of…
- Trial name
- SCLERAMAC (NCT04244916)
- Testing
- AUC of MPA measure
- Where
- France
- Volunteers
- 2 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Systemic Sclerosis (SSc), Scleroderma
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label…
- Trial name
- NCT06843239
- Testing
- Tibulizumab
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 80 people
- Sponsor
- Zura Bio Inc
Diffuse Cutaneous Systemic Sclerosis
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT02465437
- Testing
- JBT-101, Part B Open-Label Extension
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases.
- Conditions
- Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis, SLE Nephritis, ANCA Associated Vasculitis
- Trial name
- CARTIMMUNE (NCT06152172)
- Testing
- KYV-101, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- David Porter
Diffuse Cutaneous Systemic Sclerosis
Mycophenolate Mofetil in Systemic Sclerosis
This is a research study of an investigational product called Mycophenolate mofetil (MMF). The study is designed to establish the safety and potential benefit of MMF.
- Trial name
- NCT00433186
- Testing
- Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston University
Systemic Sclerosis
The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis
Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal…
- Trial name
- NCT06546540
- Testing
- Telitacicept
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Peking University Third Hospital
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Systemic Sclerosis, Scleroderma
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc).
- Trial name
- TOFA-SSc (NCT03274076)
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
Autoimmune Diseases, Sickle Cell Disease
Microvascular and Fibrosis Imaging Study
In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess…
- Conditions
- Autoimmune Diseases, Sickle Cell Disease, Chronic Graft Versus Host Disease
- Trial name
- NCT01758250
- Testing
- Acoustic Radiation Force Impulse (ARFI), Laser Doppler Flowmetry (LDF), Laser Doppler Perfusion Imaging (LDI)
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Duke University
Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT06400303
- Testing
- KYV-101, Standard lymphodepletion regimen
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kyverna Therapeutics
Diffuse Systemic Sclerosis
Serial Night Time Position Splint on Systemic Sclerosis
This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during…
- Trial name
- NCT01586663
- Testing
- Serial night time position splint, Drug treatment
- Where
- Brazil
- Volunteers
- 76 people
- Sponsor
- Federal University of São Paulo
Morphea, Scleroderma, Localized
A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and…
- Conditions
- Morphea, Scleroderma, Localized, Scleroderma
- Trial name
- NCT03740724
- Testing
- FCX-013, veledimex
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Castle Creek Biosciences, LLC.
Systemic Sclerosis
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis. II.
- Trial name
- NCT00016458
- Testing
- anti-thymocyte globulin, cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Fred Hutchinson Cancer Center
Systemic Sclerosis
Prednisolone in Early Diffuse Systemic Sclerosis
This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- PRedSS (NCT03708718)
- Testing
- Prednisolone 5 mg
- Where
- 14 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- Prof. Ariane herrick
Scleroderma, Diffuse
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis…
- Trial name
- NCT06655896
- Testing
- rapcabtagene autoleucel, rituximab
- Where
- 93 sites in United States, Argentina and 20 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
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
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