Clinical trials: Scleroderma, Diffuse
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
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
Diffuse Cutaneous Systemic Sclerosis
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT02465437
- Testing
- JBT-101, Part B Open-Label Extension
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Corbus Pharmaceuticals 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.
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 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
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
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
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, Sclerosis, Systemic
Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.
- Conditions
- Scleroderma, Systemic, Sclerosis, Systemic, Systemic Scleroderma, Systemic Sclerosis
- Trial name
- NCT01559129
- Testing
- Pomalidomide (CC-4047)
- Where
- 56 sites in United States, Australia and 8 more
- Volunteers
- 23 people
- Sponsor
- Celgene
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
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
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.
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
Lung Diseases, Interstitial
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
- Trial name
- NCT03313180
- Testing
- Nintedanib
- Where
- 159 sites in United States, Argentina and 28 more
- Volunteers
- 444 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
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.
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.
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