Clinical trials: Systemic Sclerosis, Diffuse
Scleroderma, Raynaud's Syndrome
Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome.
- Trial name
- NCT02165111
- Testing
- Onabotulinumtoxin A, sterile saline solution
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins University
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
Scleroderma, Systemic, Scleroderma, Diffuse
Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis.
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Raynaud Phenomenon
- Trial name
- NCT01347008
- Testing
- Sildenafil citrate
- Where
- Brazil
- Volunteers
- 41 people
- Sponsor
- Federal University of São Paulo
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
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
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.
Dry Eye, Sjogren's Syndrome
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort.
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Trial name
- NCT01393132
- Testing
- Thymosin Beta 4 eye drops, Vehicle Control
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Michigan Cornea Consultants, PC
Scleroderma
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis.
- Trial name
- TAMER (NCT02370784)
- Testing
- atorvastatin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Robyn T. Domsic, MD, MPH
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)
CREST Syndrome, Peripheral Vascular Disease
Exparel as a Nerve Block for Severe Hand Pain
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
- Conditions
- CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease, Scleroderma, Diffuse
- Trial name
- NCT02374320
- Testing
- liposomal bupivacaine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jose Soberon, MD
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
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
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
Scleroderma
Hands on - a Hand Care Guide in Systemic Sclerosis
Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.
- Trial name
- NCT02610842
- Testing
- Handbook
- Where
- 2 sites in Brazil
- Volunteers
- 27 people
- Sponsor
- University of Campinas, Brazil
Scleroderma
Scleroderma ARFI Imaging of the Skin
Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.
- Trial name
- ARFI (NCT02006420)
- Testing
- ARFI-SVI Ultrasound
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Scleroderma, Systemic Sclerosis
Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe.
- Trial name
- SPIN-HAND-F (NCT03092024)
- Testing
- SPIN-HAND program
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Lady Davis Institute
Diffuse Cutaneous Systemic Sclerosis
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
- Trial name
- ASSET (NCT02161406)
- Testing
- Abatacept
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 88 people
- Sponsor
- Dinesh Khanna, MD, MS
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
Scleroderma
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.
- Trial name
- NCT00764309
- Testing
- dasatinib
- Where
- 13 sites in United States
- Volunteers
- 47 people
- Sponsor
- Bristol-Myers Squibb
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.