Clinical Trials

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 12 weeks of RO7303509 treatment in patients with systemic sclerosis (SSc) during a multiple-ascending dose (MAD) portion of the trial.

The long-term safety and tolerability of up to 52 weeks of RO7303509 treatment will also be evaluated in an optional open-label safety extension (OSE).
 

This study aims to evaluate if the skin thickness (the measurement of the dermis) or stiffness as part of the US-SWE exam as we can see it on grayscale US differs between SSc patients and controls and to evaluate if there is associated liver stiffness by US-SWE in patients with SSc as compared to controls.

The purpose of this study is to allow standardized collection of clinical information, survey information, and blood samples from patients with scleroderma, and allows for use of that data for future epidemiological and translational research projects.

The purpose of this research is to create a fecal biorepository to study the differences in fecal microbes between patients with systemic sclerosis and patients without systemic sclerosis, as well as to determine the relation between the microbiome in the small intestine and the permeability of the small intestine in patients with systemic sclerosis.

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The primary purpose of this study is to demonstrate the effectiveness of 1 or 2 dose levels of HZN-825 versus placebo in subjects with diffuse cutaneous Cutaneous System Sclerosis (SSc), as determined by a comparison of change in forced vital capacity (FVC) % predicted after 52 weeks of treatment.

The purpose of this study is to evaluate the effectiveness and safety of KD025 in patients with diffuse cutaneous systemic sclerosis. Upon eligibility confirmation, a total of sixty (60) adult subjects will be enrolled and randomized into three (3) groups (1:1:1) to either receive orally administered KD025 (two doses) or matched placebo for 28 weeks. The study will be double-blinded for the first 28 weeks followed by an open label extension period of 24 weeks. After un-blinding, the subjects on KD025 will continue on the same KD025 dose whereas the subjects in the placebo group will be re-randomized to one of ...

The purpose of this study is to assess the safety and effectiveness of subcutaneous abatacept in patients with diffuse cutaneous systemic sclerosis.

The purpose of this study is to evaluate the effectiveness and safety of KD025 to treat Diffuse Cutaneous Systemic Sclerosis.

The purpose of this study is to assess whether our not the percentage of pulmonary related vascular structures (PRVS) determined by the quantitative CT (Q-CT) tool CALIPER is a novel measure that can be used for the early detection of pulmonary vascular remodeling in patients with SSc.  pulmonary related vascular structures

The purpose of this study is to evaluate the safety and effieativeness of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

The purpose of this study is to to evaluate patients undergoing the FDA-approved UVA1 phototherapy for systemic sclerosis pre, post, and during treatment for changes in their Raynaud’s phenomenon (RP) burden, digital ulcerations, and piecemeal necrosis.

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as ...

The purpose of this study is to evaluate the safety and effectiveness of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).

The purpose of this study is to evaluate the safety and tolerability of ixazomib in patients with scleroderma.

The purpose of this study is to retrospectively review the charts of 200 patients for whom overnight oximetry data, pulmonary function tests, as well as echocardiographic data have been obtained as part of routine clinical assessment. In so doing, the hope is to assess the risk of sleep disorder breathing, as evidenced by the oxygen desaturation index (ODI) on overnight oximetry assessment.

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).