Clinical trials: Scleroderma
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
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diffuse Cutaneous Systemic Sclerosis, Scleroderma
Brentuximab Vedotin for Systemic Sclerosis
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved…
- Conditions
- Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
- Trial name
- BRAVOS (NCT03222492)
- Testing
- Brentuximab Vedotin
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Scars, Scleroderma
Laser Treatment for the Improvement of Scars and Scleroderma
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
- Trial name
- NCT04567537
- Testing
- Laser Treatment
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit.
- Trial name
- NCT04781543
- Testing
- HZN-825 BID, HZN-825 QD
- Where
- 4 sites in Serbia, Spain
- Volunteers
- 301 people
- Sponsor
- Amgen
Systemic Sclerosis
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
- Trial name
- NCT05214794
- Testing
- nemolizumab
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Maruho Co., Ltd.
Pulmonary Vascular Disorder, Primary Pulmonary Hypertension
Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
This is a randomized, double-blind, placebo-controlled, multicenter, multinational study investigating the effect of riociguat (MK-4836) in patients with early pulmonary vascular disease.
- Conditions
- Pulmonary Vascular Disorder, Primary Pulmonary Hypertension, Systemic Sclerosis, Other Systemic Involvement of Connective Tissue
- Trial name
- ESRA (NCT05339087)
- Testing
- Riociguat Oral Tablet
- Where
- 8 sites in Austria, France and 4 more
- Volunteers
- 35 people
- Sponsor
- Heidelberg University
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
Diffuse Cutaneous Systemic Sclerosis
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
- Trial name
- NCT04440592
- Testing
- MT-7117
- Where
- 34 sites in United States, Belgium and 6 more
- Volunteers
- 76 people
- Sponsor
- Tanabe Pharma America, Inc.
Scleroderma, Systemic
A Study of Guselkumab in Participants With Systemic Sclerosis
The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
- Trial name
- NCT04683029
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2
- Where
- 4 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Janssen Pharmaceutical K.K.
Raynaud Phenomenon Secondary to Systemic Sclerosis
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon…
- Trial name
- NCT03867097
- Testing
- Iloprost Injection, for intravenous use
- Where
- 16 sites in United States
- Volunteers
- 34 people
- Sponsor
- Civi Biopharma, Inc.
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with…
- Trial name
- NCT04040322
- Testing
- Iloprost Injection, for intravenous use
- Where
- 30 sites in United States
- Volunteers
- 198 people
- Sponsor
- Civi Biopharma, Inc.
Systemic Sclerosis, Scleroderma
A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients
The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs…
- Conditions
- Systemic Sclerosis, Scleroderma, Diffuse Systemic Sclerosis, Diffuse Scleroderma
- Trial name
- NCT04837131
- Testing
- Ixazomib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Michael M. Pham
Systemic Sclerosis, Fatigue
Apollo Device for Fatigue in Systemic Sclerosis
The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic…
- Conditions
- Systemic Sclerosis, Fatigue, Raynaud Phenomenon
- Trial name
- NCT04854850
- Testing
- Apollo
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Robyn T. Domsic, MD, MPH
Digital Ulcers
Bosentan in Digital Ulcers
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).
- Trial name
- RAPIDS 2 OL (NCT00319696)
- Testing
- Bosentan 62.5 mg, Bosentan 125 mg
- Volunteers
- 116 people
- Sponsor
- Actelion
Digital Ulcers
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration.
- Trial name
- DUAL-2 (NCT01474122)
- Testing
- Macitentan 3 mg, Macitentan 10 mg
- Volunteers
- 265 people
- Sponsor
- Actelion
Systemic Scleroderma
Scleroderma Treatment With Autologous Transplant (STAT) Study
This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic…
- Trial name
- STAT (NCT01413100)
- Testing
- Anti-Thymocyte Globulin, Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide
- Where
- 12 sites in United States
- Volunteers
- 21 people
- Sponsor
- Fred Hutchinson Cancer Center
Systemic Sclerosis
A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis
The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).
- Trial name
- NCT04744207
- Testing
- GS-248
- Where
- 12 sites in Belgium, Netherlands and 2 more
- Volunteers
- 94 people
- Sponsor
- Gesynta Pharma AB
Diffuse Cutaneous Systemic Sclerosis
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody…
- Trial name
- NCT04478994
- Testing
- TEPEZZA
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Amgen
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