Clinical trials: Diffuse Cutaneous Scleroderma
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
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
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
Scleroderma, Diffuse, Scleroderma, Systemic
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary…
- Conditions
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic
- Trial name
- NCT02682511
- Testing
- Oral Ifetroban
- Where
- 13 sites in United States, India
- Volunteers
- 34 people
- Sponsor
- Cumberland Pharmaceuticals
Diffuse Cutaneous Systemic Sclerosis, Scleroderma
Brentuximab Vedotin for Systemic Sclerosis
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved…
- Conditions
- Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
- Trial name
- BRAVOS (NCT03222492)
- Testing
- Brentuximab Vedotin
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
- Trial name
- NCT03919799
- Testing
- Belumosudil (KD025)
- Where
- 26 sites in United States
- Volunteers
- 36 people
- Sponsor
- Kadmon, a Sanofi Company
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, 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 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
Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis
This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- dcSSC (NCT04680975)
- Testing
- Belumosudil
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon, a Sanofi Company
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
Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Extracorporeal Photopheresis in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04986605
- Testing
- Extracorporeal Photopheresis (ECP), UVADEX
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Systemic Sclerosis, Scleroderma
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases.
- Trial name
- NCT00043706
- Testing
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- Where
- 4 sites in United States
- Sponsor
- Genzyme, a Sanofi Company
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
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
- Trial name
- NCT04440592
- Testing
- MT-7117
- Where
- 34 sites in United States, Belgium and 6 more
- Volunteers
- 76 people
- Sponsor
- Tanabe Pharma America, 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
Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA)
Controlling Hyperactive Immunity With Long-lived Lymphocytes
This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid…
- Conditions
- Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Autoimmune Rheumatologic Disease
- Trial name
- CHILL (NCT07473154)
- Testing
- QEL-005
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 16 people
- Sponsor
- Quell Therapeutics Limited
Scleroderma, Systemic Sclerosis
Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma
To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital ulcers, and joint contractures.
- Trial name
- NCT02166229
- Testing
- Divalproex sodium
- Where
- United States
- Sponsor
- Yale University
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.