Clinical trials: Scleroderma
Scleroderma, Systemic Sclerosis
Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1
Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients.
- Trial name
- SPIN-CLEAR #1 (NCT06373263)
- Testing
- Plain-language summary, Dissemination Tool (Infographic)
- Where
- Canada
- Volunteers
- 511 people
- Sponsor
- Lady Davis Institute
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 17 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
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
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD).
- Trial name
- BLISSc-ILD (NCT05878717)
- Testing
- Belimumab
- Where
- 134 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Systemic Sclerosis (SSc)
Clinical Study of CD19 CAR-T in the Treatment of Refractory Systemic Sclerosis
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset systemic sclerosis
- Trial name
- NCT06792344
- Testing
- anti-CD19 CAR-T cells
- Where
- 2 sites in China, Christmas Island
- Volunteers
- 12 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
IgG4 Related Disease, Systemic Sclerosis (SSc)
Nebulized UC-EVs for Recurrent or Refractory IMIDs With Lung Involvement
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs.
- Trial name
- NCT07806045
- Testing
- nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Qiubai Li
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
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
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
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
Systemic Scleroderma
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to…
- Trial name
- NCT04380831
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Intensity-Modulated Radiation Therapy
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- City of Hope Medical Center
Systemic Lupus Erthematosus, Sjogren's Syndrome
Mass Spectrometry-based Immune Profiling in Autoimmune Diseases
Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an…
- Conditions
- Systemic Lupus Erthematosus, Sjogren's Syndrome, Inflammatory Myopathies, Systemic Sclerosis (SSc)
- Trial name
- NCT07188285
- Where
- China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Peking University People's Hospital
Arthritis, Rheumatoid, Spondylitis, Ankylosing
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations.
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Scleroderma, Systemic
- Trial name
- MARIGYN (NCT05961267)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 318 people
- Sponsor
- University Hospital, Bordeaux
Scleroderma Systemic
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities.
- Trial name
- ScleroBross (NCT04627857)
- Testing
- Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss), Sonic toothbrush
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Strasbourg, France
Systemic Lupus Erythematosus, Systemic Scleroderma
Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome
- Trial name
- AutoB-Tetramer (NCT07251179)
- Testing
- blood draw
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Strasbourg, France
Scleroderma Systemic
Periodontal Microbiota in Systemic Sclerosis
Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals…
- Trial name
- Periomicross (NCT06182293)
- Testing
- Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Strasbourg, France
Interstitial Lung Disease Due to Systemic Disease, Scleroderma
Platform Clinical Study for Conquering Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with…
- Trial name
- CONQUEST (NCT06195072)
- Testing
- Amlitelimab, BI 1015550 (Nerandomilast)
- Where
- 34 sites in United States
- Volunteers
- 400 people
- Sponsor
- Scleroderma Research Foundation, Inc.
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases.
- Trial name
- Botox SSc-RP (NCT07759557)
- Testing
- Botulinum toxin A via microneedle, Control (Normal saline)
- Volunteers
- 72 people
- Sponsor
- Khon Kaen University
Systemic Sclerosis, Diffuse Sclerosis Systemic
Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment…
- Conditions
- Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
- Trial name
- SSc (NCT03630211)
- Testing
- Cyclophosphamide, Mesna, Rituximab
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paul Szabolcs