Clinical trials: Scleroderma, Diffuse
Autoimmune Disorders, Systemic Sclerosis
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and…
- Conditions
- Autoimmune Disorders, Systemic Sclerosis, Systemic Lupus Erythematosus, Lupus
- Trial name
- NCT06434363
- Testing
- Tafasitamab, Fludarabine phosphate, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- M.D. Anderson Cancer Center
Scleroderma, Systemic
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
The aim of the study is evaluating the efficacy of organized education process of the modified Rodnan Skin Score (MRSS) in the systemic sclerosis.
- Trial name
- NCT03219606
- Testing
- Organized education course of Modified Rodnan Skin Scoring
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital
Lupus Erythematosus, Systemic, System; Sclerosis
Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM/PM, and AAV.
- Conditions
- Lupus Erythematosus, Systemic, System; Sclerosis, ANCA Associated Vasculitis, Dermatomyositis
- Trial name
- CATARSIS (NCT06685042)
- Testing
- CAR T cell
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scleroderma, Scleroderma, Systemic
Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program
Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety…
- Conditions
- Scleroderma, Scleroderma, Systemic, Systemic Sclerosis
- Trial name
- SPIN-CHAT (NCT04335279)
- Testing
- SPIN-CHAT Program
- Where
- Canada
- Volunteers
- 172 people
- Sponsor
- Lady Davis Institute
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)
The Clinical Study on the Treatment of SSc With UTAA91 Injection.
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory…
- Trial name
- NCT07000682
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Sclerosis
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
- Trial name
- NCT05214794
- Testing
- nemolizumab
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Maruho Co., Ltd.
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Systemic Sclerosis, Pulmonary; Hypertension
Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients.
- Trial name
- NCT02981082
- Testing
- Dimethyl Fumarate (DMF)
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Robert Lafyatis
Systemic Sclerosis, Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments.
- Trial name
- NCT00962923
- Testing
- Allogeneic Mesenchymal Stem Cells (AlloMSC)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Pulmonary Fibrosis, Scleroderma, Systemic
Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is…
- Trial name
- NCT00070590
- Testing
- Bosentan
- Volunteers
- 132 people
- Sponsor
- Actelion
Refractory Lupus Nephritis, Systemic Sclerosis
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Trial name
- NCT06947460
- Testing
- CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
Lupus Erythematosus, Scleroderma
Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
The aim of this project is to start a biological and clinical collection of patients presenting systemic autoimmune disease. This collection will provide appropriate biological samples to identify new biomarkers and to be…
- Conditions
- Lupus Erythematosus, Scleroderma, Myositis, Vasculitis
- Trial name
- ESSAi (NCT05251415)
- Testing
- Blood sampling
- Where
- France
- Volunteers
- 3,000 people
- Sponsor
- University Hospital, Toulouse
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 Sclerosis
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies.
- Trial name
- SCLERONAB (NCT06412614)
- Testing
- disease phenotype
- Where
- 14 sites in France
- Volunteers
- 300 people
- Sponsor
- Central Hospital, Nancy, France
Systemic Sclerosis
Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients With Systemic Sclerosis
OBJECTIVES: I. Determine whether defects in fibrillin-1 cellular processing are present in the tsk1 mouse model that carries a known FBN1 gene rearrangement and in a population of Choctaw Native American patients with systemic…
- Trial name
- NCT00006393
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)
Systemic Sclerosis (SSc)
A Phase II Study of TollB-001 Tablets in Systemic Sclerosis
The goal of this Phase II study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of TollB-001 Tablets in adults aged 18 to 70 years (male or female) with systemic sclerosis (SSc).
- Trial name
- NCT07745725
- Testing
- TollB-001 Tablet
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Toll Biotech Co. Ltd. (Beijing)
Systemic Sclerosis, Scleroderma
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin.
- Trial name
- DISTOL-1 (NCT00775463)
- Testing
- treprostinil diethanolamine
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 148 people
- Sponsor
- United Therapeutics
Scleroderma
Effectiveness and Safety of Lidocaine for Scleroderma
Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases.
- Trial name
- NCT00740285
- Testing
- Lidocaine 2% without vessel constrictor
- Where
- Brazil
- Volunteers
- 26 people
- Sponsor
- Federal University of São Paulo