Clinical trials: Scleroderma
Systemic Sclerosis (SSc)
DERMATOMICS: Identifying Regulators of Skin Homeostasis
Diseases of the skin associated with chronic immune driven conditions, including scleroderma, lupus, dermatomyositis, psoriasis, and atopic dermatitis, significantly impact skin integrity, function, and overall quality of life.
- Trial name
- DERMATOMICS (NCT06894654)
- Testing
- Skin punch biopsy, blood sampling, Questionnaire
- Where
- 2 sites in United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Relation Therapeutics
Scleroderma, Gastroparesis
TENS in Scleroderma
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis.
- Conditions
- Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
- Trial name
- NCT06646913
- Testing
- Transcutaneous Electrical Nerve Stimulation
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
Systemic Lupus Erythematosus, Scleroderma
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
- Conditions
- Systemic Lupus Erythematosus, Scleroderma, Rheumatoid Arthritis
- Trial name
- SLE，SSc，RA (NCT06801119)
- Testing
- HN2301 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
Autoimmune Disease, Systemic Lupus Erythematosus
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
- Conditions
- Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
- Trial name
- AID (NCT07523282)
- Testing
- HN2302 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
Pericarditis, Tako-TSUBO Cardiomyopathy
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with…
- Conditions
- Pericarditis, Tako-TSUBO Cardiomyopathy, Myocarditis, Inflammatory Cardiomyopathies
- Trial name
- INFLAME-BANK (NCT07737470)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually…
- Trial name
- RE-WARM (NCT07748000)
- Testing
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm, LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Volunteers
- 75 people
- Sponsor
- Liquidia Technologies, Inc.
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 Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs)
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically…
- Conditions
- Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA
- Trial name
- NCT06991114
- Testing
- Allogeneic NK Cells
- Where
- 52 sites in United States, Brazil and 9 more
- Volunteers
- 90 people
- Sponsor
- Artiva Biotherapeutics, Inc.
D013493
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin.
- Trial name
- OBSKINS (NCT07543679)
- Testing
- ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Study of AZD0120 in Autoimmune Diseases
This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc)…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- AURORA (NCT07295847)
- Testing
- AZD0120
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
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
Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease
The OXISITE-ILD study is a prospective, multicenter, observational study designed to evaluate the agreement between finger (digital) and earlobe (auricular) pulse oximetry for measuring oxygen saturation (SpO2) during the…
- Conditions
- Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Connective Tissue Disease-Associated Interstitial Lung Disease
- Trial name
- OXISITE-ILD (NCT07723872)
- Testing
- Dual-site pulse oximetry (finger and earlobe)
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital de Granollers
Systemic Sclerosis, Pulmonary Arterial Hypertension
Extracellular Vesicle Dynamics Predicting Vascular Complications and Treatment Response in Systemic Sclerosis
Systemic sclerosis is a multisystem autoimmune disease characterized by vascular dysfunction, immune dysregulation, and progressive tissue fibrosis.
- Conditions
- Systemic Sclerosis, Pulmonary Arterial Hypertension, Digital Ulcers, Vascular Complications
- Trial name
- EVOLVE-SSc (NCT07717060)
- Testing
- Blood sampling, nailfold capillaroscopy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital