Ashima Makol, M.B.B.S.

The purpose of this multinational, randomized, placebo-controlled, and double­ blind study is to evaluate the safety and efficacy of subcutaneous (SC) anifrolumab in adult patients with systemic sclerosis (SSc), who may be taking one or a combination of protocol­ specified standard therapies. Following 52-weeks of double-blind, placebo-controlled treatment, a 52-week open-label treatment period is included to assess long-term safety in Systemic Sclerosis (SSc).

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 to develop an early systemic sclerosis ((SSc), scleroderma defined as < 5 years from 1st non- Raynaud’s Phenomenon (RP) symptom attributable to SSc) observational cohort in the United States (US).

The purpose of this study is the evaluation of morphology of capillaries in nailfolds of healthy children and children with the diagnosis of systemic auto-immune/inflammatory diseases.

The purpose of this study is to evaluate the efficacy of the investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in forced vital capacity (FVC) (mL), measured in study participants with SSc-ILD.

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 treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis.

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).
 

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 KD025 doses.

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 find out whether BI 685509 helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. 

The purpose of this study is to investigate the role of nailfold capillaroscopy in the assessment of patients with Systemic Lupus Erythematosus (SLE).

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.