Clinical trials: Systemic Scleroderma
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
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
Skin Fibrosis
Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study
Transforming growth factor-beta 1 is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts(25, 26).
- Trial name
- NCT00781053
- Testing
- P144 cream
- Where
- 17 sites in Germany, Hungary and 4 more
- Volunteers
- 38 people
- Sponsor
- ISDIN
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
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 (SSc), Scleroderma
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label…
- Trial name
- NCT06843239
- Testing
- Tibulizumab
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 80 people
- Sponsor
- Zura Bio Inc
Scleroderma
Scleroderma Treatment With Celution Processed ADRCs Registry
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
- Trial name
- STAR (NCT02328625)
- Sponsor
- Cytori Therapeutics
Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated…
- Trial name
- NCT05785624
- Testing
- Vixarelimab
- Where
- 114 sites in United States, Argentina and 17 more
- Volunteers
- 286 people
- Sponsor
- Genentech, Inc.
Systemic Sclerosis
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this…
- Trial name
- NCT07047690
- Testing
- Nemolizumab
- Where
- 3 sites in United States, Switzerland
- Volunteers
- 162 people
- Sponsor
- Galderma R&D
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.
Raynaud's Disease, Scleroderma
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
- Conditions
- Raynaud's Disease, Scleroderma, Autoimmune Diseases
- Trial name
- NCT00419419
- Testing
- Topical AmphiMatrix with nitroglycerin (MQX-503)
- Where
- 12 sites in United States, Sweden and 1 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- MediQuest Therapeutics
Skin Fibrosis
Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis
Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts.
- Trial name
- NCT00574613
- Testing
- P144
- Where
- 17 sites in Germany, Hungary and 4 more
- Volunteers
- 56 people
- Sponsor
- ISDIN
Systemic Sclerosis
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT02921971
- Testing
- SAR156597
- Where
- 44 sites in United States, Argentina and 11 more
- Volunteers
- 97 people
- Sponsor
- Sanofi
Interstitial Lung Disease
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD.
- Trial name
- NCT05892614
- Testing
- efzofitimod 450 mg, efzofitimod 270 mg
- Where
- 15 sites in United States
- Volunteers
- 25 people
- Sponsor
- aTyr Pharma, Inc.
Lung Diseases, Interstitial
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients…
- Trial name
- NCT04325217
- Testing
- Nintedanib
- Where
- Japan
- Volunteers
- 586 people
- Sponsor
- Boehringer Ingelheim
Autoimmune Disease, Systemic Lupus Erythematosus
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
- Conditions
- Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
- Trial name
- AID (NCT07523282)
- Testing
- HN2302 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
Scleroderma, Diffuse
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis…
- Trial name
- NCT06655896
- Testing
- rapcabtagene autoleucel, rituximab
- Where
- 93 sites in United States, Argentina and 20 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Scleroderma
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
- Trial name
- MEDI-546 (NCT00930683)
- Testing
- MEDI-546
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- MedImmune LLC