Clinical trials: Diffuse Cutaneous Systemic Sclerosis
Scleroderma Disease
Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases
This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide i.m.
- Trial name
- NCT03388255
- Testing
- Polydeoxyribonucleotides
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Mastelli S.r.l
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
AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis
To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation.
- Trial name
- NCT00769028
- Testing
- Hyperimmune caprine serum, Albumin
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Daval International Limited
Diffuse Cutaneous Systemic Sclerosis
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- NCT04166552
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 36 people
- Sponsor
- Emerald Health Pharmaceuticals
Healthy, Systemic Sclerosis
Systemic Sclerosis Clinical and Biomarker Study
The primary objective of the study is to assess the change in systemic sclerosis (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants with SSc.
- Trial name
- NCT02531009
- Volunteers
- healthy volunteers welcome
- Sponsor
- Biogen
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 Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
- Trial name
- NCT06470048
- Testing
- Ianalumab
- Where
- 106 sites in United States, Argentina and 23 more
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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
Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
- Trial name
- ATHENA-SSc-ILD (NCT05270668)
- Testing
- Tulisokibart, Companion diagnostic ( CDx)
- Where
- 95 sites in United States, Argentina and 18 more
- Volunteers
- 154 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, 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
Scleroderma
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.
- Trial name
- NCT02588625
- Testing
- BMS-986020
- Where
- 27 sites in United States, Canada and 2 more
- Sponsor
- Bristol-Myers Squibb
Systemic Sclerosis, Scleroderma
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis.
- Trial name
- DAISY (NCT05925803)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 150 sites in United States, Austria and 21 more
- Volunteers
- 314 people
- Sponsor
- AstraZeneca
Systemic Sclerosis
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Primary Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT01651143
- Testing
- SAR100842
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
Connective Tissue Diseases
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the…
- Trial name
- NCT06716606
- Testing
- Belimumab
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 514 people
- Sponsor
- GlaxoSmithKline
Scleroderma, Digital Ulcer
Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
Digital Ulcers (DEs), are painful open sores on the fingers and toes and are due to limited perfusion of blood vessels in patients with Scleroderma.
- Conditions
- Scleroderma, Digital Ulcer, Autoimmune Diseases, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CURE (NCT05168215)
- Where
- Greece
- Volunteers
- 300 people
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Diffuse Cutaneous Systemic Sclerosis
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-474 in Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
- Trial name
- NCT07287670
- Testing
- MTX-474
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 85 people
- Sponsor
- Mediar Therapeutics
Systemic Sclerosis With and Without Interstitial Lung Disease
A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)
The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.
- Trial name
- NCT04948554
- Testing
- MK-2225
- Where
- 16 sites in United States, Canada and 2 more
- Volunteers
- 5 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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