Clinical trials: Scleroderma
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.
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.
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 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
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
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.
Systemic Sclerosis, Scleroderma
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin.
- Trial name
- DISTOL-1 (NCT00775463)
- Testing
- treprostinil diethanolamine
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 148 people
- Sponsor
- United Therapeutics
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
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, 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
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
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis
This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- dcSSC (NCT04680975)
- Testing
- Belumosudil
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon, a Sanofi Company