Clinical trials: Systemic Sclerosis (SSc)
Systemic Sclerosis, Pulmonary; Hypertension
Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients.
- Trial name
- NCT02981082
- Testing
- Dimethyl Fumarate (DMF)
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Robert Lafyatis
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy…
- Trial name
- NCT04036227
- Testing
- GS-248
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
Systemic Sclerosis-associated Interstitial Lung Disease
Abituzumab in SSc-ILD
The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the…
- Trial name
- NCT02745145
- Testing
- Abituzumab 1500 mg, Abituzumab 500 mg
- Where
- 55 sites in United States, Argentina and 7 more
- Volunteers
- 24 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Ischemia
Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet
The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in…
- Trial name
- ambrisentan (NCT01072669)
- Testing
- ambrisentan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Soumya Chatterjee
Lung Diseases, Interstitial, Systemic Sclerosis
Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
The purpose of this study is to look at whether bortezomib, mycophenolate or the combination of both is better to treat scarring of the lung caused by Systemic Sclerosis.
- Conditions
- Lung Diseases, Interstitial, Systemic Sclerosis, Scleroderma
- Trial name
- NCT02370693
- Testing
- Bortezomib, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
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
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
Systemic Sclerosis, Pulmonary Hypertension
Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)
Trial Design Patients with borderline PAH indicated by borderline mPAP values will be included in this single centre study. This clinical investigation is performed as a Proof-of-Concept (PoC) investigator initiated trial (IIT)…
- Trial name
- EDITA (NCT02290613)
- Testing
- Ambrisentan
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Heidelberg University
Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
The purpose of this study is to determine whether oral temanogrel improves digital blood flow in participants with Raynaud's phenomenon secondary to systemic sclerosis (SSc-RP) as a potential safe and effective treatment for…
- Trial name
- NCT04915950
- Testing
- Temanogrel
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Pfizer
Raynaud Phenomenon, Systemic Sclerosis
Cold Challenge With C21 in RP
This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis.
- Trial name
- NCT04388176
- Testing
- C21
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Vicore Pharma AB
Systemic Sclerosis-Associated PAH
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis)…
- Trial name
- NCT01086540
- Testing
- Rituximab, CMRI, prednisone
- Where
- 17 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rheumatologic Disease
Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment
Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by activation of immune cells, which results in vascular dysfunction (vasculopathy) and subsequent scarring (fibrosis).
- Trial name
- Scleroderma (NCT02530996)
- Testing
- BH4, Vasculopathy assessment
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Scleroderma, Systemic
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.
- Trial name
- NCT03675581
- Testing
- Microgynon, Nintedanib
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 17 people
- Sponsor
- Boehringer Ingelheim
Systemic Sclerosis
Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is compromised in about 75% of patients. Previous studies have shown that buspirone, an orally available 5-HT1A (serotonin 1a receptor agonist)…
- Trial name
- NCT02363478
- Testing
- buspirone
- Where
- Greece
- Volunteers
- 22 people
- Sponsor
- Laikο General Hospital, Athens
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
Systemic Sclerosis
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
- Trial name
- LOTUSS (NCT01933334)
- Testing
- Pirfenidone
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 63 people
- Sponsor
- Genentech, Inc.
Scleroderma
Taking Charge of Systemic Sclerosis
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative…
- Trial name
- TOSS (NCT02494401)
- Testing
- Internet-based self-management program, Scleroderma book
- Where
- United States
- Volunteers
- 267 people
- Sponsor
- University of Michigan
Scleroderma, Systemic
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality.
- Trial name
- NCT02597933
- Testing
- Nintedanib
- Where
- 195 sites in United States, Argentina and 30 more
- Volunteers
- 580 people
- Sponsor
- Boehringer Ingelheim
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
Systemic Sclerosis
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites.
- Trial name
- focuSSced (NCT02453256)
- Testing
- Tocilizumab
- Where
- 83 sites in United States, Argentina and 20 more
- Volunteers
- 212 people
- Sponsor
- Hoffmann-La Roche