Clinical trials: Systemic Scleroses, Diffuse
Scleroderma, Interstitial Lung Disease
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection.
- Trial name
- SLSII (NCT00883129)
- Testing
- Mycophenolate mofetil, Cyclophosphamide
- Where
- 14 sites in United States
- Volunteers
- 142 people
- Sponsor
- Michael Roth
Diffuse Cutaneous Systemic Sclerosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc).
- Trial name
- RESOLVE-1 (NCT03398837)
- Testing
- Lenabasum 5 mg, Lenabasum 20 mg
- Where
- 74 sites in United States, Australia and 10 more
- Volunteers
- 365 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Scleroderma
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and…
- Trial name
- NCT04588714
- Testing
- Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan
Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease
Metabolomic Analysis of Systemic Sclerosis
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.
- Conditions
- Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Raynaud Disease, Vascular Disease
- Trial name
- SCLEROMICS (NCT02298777)
- Testing
- - Skin biopsy - Urine sample - Blood sample
- Where
- 4 sites in France
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Systemic Sclerosis, Scleroderma
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases.
- Trial name
- NCT00043706
- Testing
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- Where
- 4 sites in United States
- Sponsor
- Genzyme, a Sanofi Company
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
System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
- Trial name
- NCT03919799
- Testing
- Belumosudil (KD025)
- Where
- 26 sites in United States
- Volunteers
- 36 people
- Sponsor
- Kadmon, a Sanofi Company
Scleroderma, Systemic
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
To investigate if Riociguat is effective in the treatment of systemic sclerosis
- Trial name
- NCT02283762
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 121 people
- Sponsor
- Bayer
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
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
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
Scleroderma, System; Sclerosis
Rehabilitation Program in Patients With Scleroderma
Scleroderma (or Systemic Sclerosis - SSc) is one of the most neglected diseases worldwide, according to the World Health Organization.
- Conditions
- Scleroderma, System; Sclerosis, Muscle Strain, Physical Disability
- Trial name
- NCT05041868
- Testing
- Treatment
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Centro Universitário Augusto Motta
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.
Systemic Sclerosis, Scleroderma
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc).
- Trial name
- TOFA-SSc (NCT03274076)
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
Scleroderma, Systemic Sclerosis
Duke Scleroderma Clinic Patient Registry
The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about scleroderma. This information could be used in future research to increase the understanding of disease mechanisms, treatments, and outcomes.
- Trial name
- NCT02851875
- Testing
- Registry
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Duke University
Diffuse Cutaneous Systemic Sclerosis
A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ…
- Trial name
- FREEDOM-3 (NCT05098145)
- Testing
- FCR001
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Systemic Sclerosis, Scleroderma
Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
Systemic sclerosis is a chronic autoimmune connective tissue disorder with no universally accepted disease modifying regimen. Recruiting patients for systemic sclerosis treatment studies is difficult due to the limited…
- Trial name
- NCT01093885
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Pennsylvania
Scleroderma, Systemic Sclerosis
The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial
Many people living with a rare disease turn to peer-led support groups to cope with their condition and access educational resources.
- Trial name
- SPIN-SSLED-F (NCT03508661)
- Testing
- SPIN-SSLED Program
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Lady Davis Institute
Systemic Sclerosis, Scleroderma
Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease
Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD. Lung involvement is the most common cause of death in these patients.
- Conditions
- Systemic Sclerosis, Scleroderma, Interstitial Lung Disease
- Trial name
- MYILD (NCT02896205)
- Testing
- Mycophenolate mofetil
- Where
- India
- Volunteers
- 41 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh