Clinical trials: Sclerosis, Progressive Systemic
Systemic Sclerosis
Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis
This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose…
- Trial name
- NCT01670565
- Testing
- Belimumab, Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hospital for Special Surgery, New York
Limited Scleroderma, Diffuse Scleroderma
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.
- Trial name
- NCT01881529
- Where
- Australia
- Volunteers
- 29 people
- Sponsor
- Gilead Sciences
Scleroderma, Diffuse
High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder characterized by fibrosis of the skin and visceral organs that alters every aspect of an individual life Although some features of scleroderma…
- Trial name
- NCT00428883
- Testing
- N-acetylcysteine (NAC)
- Where
- 5 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Università Politecnica delle Marche
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines…
- Trial name
- NCT05626751
- Testing
- HZN-825
- Where
- 65 sites in United States, Argentina and 13 more
- Volunteers
- 174 people
- Sponsor
- Amgen
Interstitial Lung Disease
Pulmonary Care and Research Collaborative Patient Registry
The purpose of this research study is to build and maintain a registry of people with interstitial lung disease (ILD). Medical information collected for this registry may be used to advance ILD and pulmonary research and improve…
- Trial name
- NCT05445817
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Pulmonary Care and Research Collaborative Limited
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
Scleroderma, Systemic
Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis (SSc), a rare autoimmune disease with high morbidity and mortality.
- Trial name
- NCT03041025
- Testing
- GSK2330811
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Systemic Sclerosis, Systemic Scleroses, Diffuse
Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis
HSCT has been implemented in (inter)national treatment guidelines for diffuse cutaneous systemic sclerosis (dcSSc) and is offered in clinical care and reimbursed by national health insurance in several European countries.
- Conditions
- Systemic Sclerosis, Systemic Scleroses, Diffuse, Scleroderma, Scleroderma, Diffuse
- Trial name
- UPSIDE (NCT04464434)
- Testing
- Upfront autologous HSCT
- Where
- 8 sites in Italy, Netherlands and 1 more
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
Systemic Sclerosis, Diffuse Scleroderma
IVIG Treatment in Systemic Sclerosis
The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin) on the skin in patients with scleroderma.
- Trial name
- NCT01785056
- Testing
- Privigen
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Georgetown University
Systemic Sclerosis
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis.
- Trial name
- NCT06414135
- Testing
- Relma-cel
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Liangjing Lu
Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
- Trial name
- ATHENA-SSc-ILD (NCT05270668)
- Testing
- Tulisokibart, Companion diagnostic ( CDx)
- Where
- 95 sites in United States, Argentina and 18 more
- Volunteers
- 154 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
- Trial name
- ASSET (NCT02161406)
- Testing
- Abatacept
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 88 people
- Sponsor
- Dinesh Khanna, MD, MS
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Interstitial Lung Disease
Patient-Reported Outcome Study of Project ECHO for ILD
The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will…
- Trial name
- NCT05450276
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Pulmonary Care and Research Collaborative Limited
Systemic Sclerosis Pulmonary, Pulmonary Hypertension
Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to Treatment
Progressive SSc is an entity with limited therapeutic alternatives and a survival rate of less than 45% within the first 3 to 5 years.
- Conditions
- Systemic Sclerosis Pulmonary, Pulmonary Hypertension, Pulmonary Fibrosis
- Trial name
- NCT07542067
- Testing
- Mesenchymal Stem Cells from Wharton´s jelly
- Where
- Colombia
- Volunteers
- 1 people
- Sponsor
- Fundación Neumologica Colombiana
Interstitial Lung Diseases
Monitoring and Evaluation Study of Project ECHO for ILD
The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project…
- Trial name
- NCT05455437
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Pulmonary Care and Research Collaborative Limited
Scleroderma, Systemic, Scleroderma, Diffuse
Effects of FT011 in Systemic Sclerosis
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
- Trial name
- NCT04647890
- Testing
- FT011
- Where
- 10 sites in Australia, Netherlands and 3 more
- Volunteers
- 30 people
- Sponsor
- Certa Therapeutics
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 Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis
YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases
This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed/refractory autoimmune diseases, including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis, Idiopathic Inflammatory Myopathies (IIMs), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07439029
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Fudan University
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