Clinical trials: Systemic Sclerosis, active
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
Systemic Lupus Erythematosus, Systemic Sclerosis
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06379646
- Testing
- YTS109
- Where
- China
- Volunteers
- 6 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06978647
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
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
Systemic Sclerosis (SSc)
Mycophenolate After Stem Cell Transplant for Systemic Sclerosis
A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .
- Trial name
- IMPACT-SSc (NCT07734012)
- Testing
- Mycophenolate Mofetil 1000 mg twice daily
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Ottawa Hospital Research Institute
Systemic Sclerosis, Scleroderma
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Scleroderma, Interstitial Lung Diseases
- Trial name
- NCT06328777
- Testing
- CABA-201
- Where
- 10 sites in United States
- Volunteers
- 37 people
- Sponsor
- Cabaletta Bio
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
- Conditions
- Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis Secondary to Systemic Sclerosis, Pulmonary Fibrosis, Interstitial Lung Disease
- Trial name
- NCT06329401
- Testing
- AP01
- Where
- 154 sites in United States, Argentina and 12 more
- Volunteers
- 398 people
- Sponsor
- Avalyn Pharma Inc.
Systemic Sclerosis (SSc)
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis.
- Trial name
- eSScape (NCT06655155)
- Testing
- Efgartigimod PH20 SC
- Where
- 79 sites in United States, Argentina and 22 more
- Volunteers
- 87 people
- Sponsor
- argenx
Systemic Sclerosis, Sclerodactyly
Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial
Translational studies have demonstrated reduced hyaluronidase activity in the skin of patients with systemic sclerosis. It is thought this may contribute to the progressive fibrosis seen in this disease.
- Trial name
- HASSc (NCT07697274)
- Testing
- Hyaluronidase (Hylenex)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
Systemic Sclerosis
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either…
- Trial name
- NCT03844061
- Testing
- Belimumab, Rituximab, MMF
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hospital for Special Surgery, New York
Systemic Sclerosis
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression.
- Trial name
- VERANDA™-SSc (NCT07497087)
- Testing
- Nerandomilast formulation 1, Nerandomilast formulation 2
- Where
- 248 sites in United States, Argentina and 43 more
- Volunteers
- 448 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
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
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Systemic Sclerosis (SSc), Systemic Sclerosis
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy
This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in…
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis, Systemic Sclerosis (Scleroderma), Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT07854483
- Testing
- C-CAR168
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- AbelZeta Inc.
Healthy Volunteers, Systemic Sclerosis (SSc)
A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
- Conditions
- Healthy Volunteers, Systemic Sclerosis (SSc), Scleroderma, Systemic, Scleroderma
- Trial name
- NCT07641634
- Testing
- PRO-203
- Where
- 13 sites in Australia, China and 2 more
- Volunteers
- 44 people
- Sponsor
- Prolium Bioscience, Inc
Systemic Sclerosis (SSc)
The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis
This study aims to evaluate the effects of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will be assessed before and after the intervention.
- Trial name
- PMR-SCLERODERM (NCT07842133)
- Testing
- Progressive Muscle Relaxation Exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- University of Gaziantep
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