Clinical trials: Diffuse Cutaneous Systemic Sclerosis, active
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
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
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.
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
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
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
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
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
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
Autoimmune Diseases, Pregnancy Related
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases. The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and…
- Conditions
- Autoimmune Diseases, Pregnancy Related, Systemic Lupus Erythematosus, Cutaneous Lupus
- Trial name
- MADRA (NCT03276923)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Diffuse Cutaneous Systemic Sclerosis
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
- Trial name
- NCT06470048
- Testing
- Ianalumab
- Where
- 106 sites in United States, Argentina and 23 more
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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
Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases.
- Conditions
- Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases, Auto-inflammatory Dermatological Diseases, Skin Diseases
- Trial name
- TekAPo (NCT06387654)
- Testing
- Blood sampling, Remainders of samples taken as part of the treatment
- Where
- France
- Volunteers
- 800 people
- Sponsor
- University Hospital, Toulouse
Juvenile Idiopathic Arthritis, Rheumatoid Arthritis
Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults
Population: Juvenile idiopathic arthritis (JIA), rheumatoid arthritis (RA) and seronegative / psoriatic / undifferentiated arthritis (UA), systemic lupus erythematosus (SLE) or diffuse systemic sclerosis dSS).
- Conditions
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus
- Trial name
- NCT07000916
- Where
- Belgium
- Volunteers
- 1,000 people
- Sponsor
- Université Catholique de Louvain
Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis
YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases
This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed/refractory autoimmune diseases, including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis, Idiopathic Inflammatory Myopathies (IIMs), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07439029
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Fudan University
Systemic Sclerosis
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this…
- Trial name
- NCT07047690
- Testing
- Nemolizumab
- Where
- 3 sites in United States, Switzerland
- Volunteers
- 162 people
- Sponsor
- Galderma R&D
Systemic Sclerosis, Scleroderma
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis.
- Trial name
- DAISY (NCT05925803)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 150 sites in United States, Austria and 21 more
- Volunteers
- 314 people
- Sponsor
- AstraZeneca
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
Connective Tissue Diseases
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the…
- Trial name
- NCT06716606
- Testing
- Belimumab
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 514 people
- Sponsor
- GlaxoSmithKline
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