Clinical trials: Diffuse Cutaneous Scleroderma
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
Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases.
- Conditions
- Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases, Auto-inflammatory Dermatological Diseases, Skin Diseases
- Trial name
- TekAPo (NCT06387654)
- Testing
- Blood sampling, Remainders of samples taken as part of the treatment
- Where
- France
- Volunteers
- 800 people
- Sponsor
- University Hospital, Toulouse
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.
Morphea, Scleroderma, Localized
A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and…
- Conditions
- Morphea, Scleroderma, Localized, Scleroderma
- Trial name
- NCT03740724
- Testing
- FCX-013, veledimex
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Castle Creek Biosciences, LLC.
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
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
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
Scleroderma
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.
- Trial name
- NCT02588625
- Testing
- BMS-986020
- Where
- 27 sites in United States, Canada and 2 more
- Sponsor
- Bristol-Myers Squibb
Keloid, Scleroderma
UVA1 Light for Scleroderma and Similar Conditions
The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma…
- Conditions
- Keloid, Scleroderma, Scars, Granuloma Annulare
- Trial name
- NCT00476697
- Testing
- German manufactured UVA1 emitting light system
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Michigan
Scleroderma, Localized, Scleroderma, Systemic
Efficacy and Safety of Imatinib in Scleroderma
In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule, as recently also…
- Trial name
- SCLEROGLIVEC (NCT00479934)
- Testing
- imatinib mesylate
- Where
- 12 sites in France
- Volunteers
- 28 people
- Sponsor
- University Hospital, Bordeaux
Diffuse Systemic Sclerosis
Fresolimumab In Systemic Sclerosis
The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.
- Trial name
- NCT01284322
- Testing
- Fresolimumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Boston University
Diffuse Cutaneous Systemic Sclerosis
Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis…
- Trial name
- NCT03198689
- Testing
- Brentuximab Vedotin
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Systemic Sclerosis, Scleroderma
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis.
- Trial name
- DAISY (NCT05925803)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 150 sites in United States, Austria and 21 more
- Volunteers
- 314 people
- Sponsor
- AstraZeneca
Systemic Sclerosis
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Primary Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT01651143
- Testing
- SAR100842
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
Diffuse Systemic Sclerosis
Serial Night Time Position Splint on Systemic Sclerosis
This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during…
- Trial name
- NCT01586663
- Testing
- Serial night time position splint, Drug treatment
- Where
- Brazil
- Volunteers
- 76 people
- Sponsor
- Federal University of São Paulo
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