Clinical trials: Diffuse Cutaneous Systemic Sclerosis
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 (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
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.
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.
Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT06400303
- Testing
- KYV-101, Standard lymphodepletion regimen
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kyverna Therapeutics
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, 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
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
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
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.
- Trial name
- NCT04138485
- Testing
- IgPro10
- Where
- 77 sites in United States, Argentina and 11 more
- Sponsor
- CSL Behring
Diffuse Cutaneous Systemic Sclerosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc).
- Trial name
- RESOLVE-1 (NCT03398837)
- Testing
- Lenabasum 5 mg, Lenabasum 20 mg
- Where
- 74 sites in United States, Australia and 10 more
- Volunteers
- 365 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Diffuse Cutaneous Systemic Sclerosis
A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ…
- Trial name
- FREEDOM-3 (NCT05098145)
- Testing
- FCR001
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Scleroderma, Diffuse
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands.
- Trial name
- NCT03831438
- Testing
- AVID200
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bristol-Myers Squibb
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.
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
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
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
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
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