Clinical trials: Scleroderma
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Constipation, Bloating
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic…
- Trial name
- NCT06827977
- Testing
- PRIM-DJ2727
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- The University of Texas Health Science Center, Houston
Scleroderma, Systemic Sclerosis
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies.
- Trial name
- PSSIT (NCT05098704)
- Testing
- clopidogrel treatment
- Where
- 11 sites in France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Bordeaux
Systemic Sclerosis (SSc)
Systemic Sclerosis DIet for GastrointESTinal Symptoms
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis.
- Trial name
- DIGEST (NCT07402226)
- Testing
- Diet 1: Restriction of fermentable carbohydrates, Diet 2: Elimination of foods harmful to gut barrier and microbiome, Diet 3: Regular meal patterns, soluble fiber, and portion control
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Michigan
Spondyloarthritis (SpA), Psoriatic Arthritis (PsA)
Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity
The aim of the present work is to assess the nutritional status among different rheumatic diseases patients and to study its association with the corresponding diseases activity.
- Conditions
- Spondyloarthritis (SpA), Psoriatic Arthritis (PsA), Systemic Lupus Erythematous (SLE), Systemic Sclerosis (SSc)
- Trial name
- NCT07277491
- Where
- Egypt
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Cairo University
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Immun4Cure Cohort of Autoimmune Diseases
This prospective cohort study aims to constitute a 500-participant database and biobank including 450 adults with systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis) and 50…
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers
- Trial name
- Immun4Cure (NCT07515638)
- Testing
- Blood test and principal collection, Optional collection, Patient questionnaires
- Where
- France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
MTS109 in Patients With Refractory Autoimmune Diseases
This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV)
- Trial name
- NCT07526350
- Testing
- MTS109
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Changzheng Hospital
Multiple Sclerosis (MS), Myasthenia Gravis (MG)
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard…
- Conditions
- Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder, Systemic Lupus Erythematosus
- Trial name
- NCT07676266
- Testing
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Systemic Sclerosis
Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological…
- Trial name
- SCLEROBREST (NCT05532865)
- Testing
- Blood samples, Stool samples, Skin swab samples
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Brest
Systemic Sclerosis (SSc)
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
The objective of the study is to establish an in vitro model using iPSCs to test the hypotheses developed. The primary objective is to generate, via the SAFE-IPS platform, 8 iPSC lines derived from blood samples taken from: Two…
- Trial name
- hiPSSS (NCT07650565)
- Testing
- Blood Sample Collection
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Systemic Sclerosis
Assessment of Nutritional Status in Systemic Sclerosis
The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma.
- Trial name
- NUTRISCLER (NCT04301596)
- Testing
- Collection of data
- Where
- France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Montpellier
Atopic Dermatitis, Psoriasis
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable.
- Conditions
- Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa, Lichen Planus
- Trial name
- ImmuneSkinBank (NCT06599411)
- Testing
- Sampling
- Where
- France
- Volunteers
- 830 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
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
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Scleroderma
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active…
- Trial name
- LIBERIUS (NCT05726630)
- Testing
- Divozilimab
- Where
- 3 sites in Russia
- Volunteers
- 152 people
- Sponsor
- Biocad
Systemic Sclerosis
Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis Patients
In the current study we aim to assess the macrovascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.
- Trial name
- NCT07012655
- Testing
- Colour Doppler Ultrasound
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Assiut University
Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
- Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy, Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- Trial name
- NCT07490275
- Testing
- Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide, Fludarabine
- Volunteers
- 9 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China