Clinical trials: Scleroderma Systemic
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.
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 Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis
The main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis.
- Trial name
- NOVESA (NCT03798366)
- Testing
- GLPG1690
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 33 people
- Sponsor
- Lakefront Biotherapeutics NV
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
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
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.
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
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
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
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.
Systemic Sclerosis, Scleroderma
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis.
- Trial name
- NCT00613171
- Testing
- STI571
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
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.
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
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
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, Ulcers
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
The DUAL-1 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-1 (NCT01474109)
- Testing
- macitentan 3mg, macitentan 10mg
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 289 people
- Sponsor
- Actelion
Systemic Sclerosis
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side…
- Trial name
- NCT03976648
- Testing
- GLPG1690
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 31 people
- Sponsor
- Lakefront Biotherapeutics NV
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.