Active clinical trials for "Autoimmune Diseases"

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care

Human, absorption, metabolism and excretion study of belumosudil (KD025)

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

This is a two part protocol (Parts A and B) in healthy volunteers evaluating the pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide (LPS) stimulation) as markers of macrolide anti-inflammatory activity. Part A is a randomized, open-label parallel group study evaluating PK/PD of a single azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory conditions). This information will guide the range of doses to be studied in a first time in humans (FTIH) study of a new chemical entity. Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil related inflammatory conditions. This information will provide insight into whether the biomarker effects change over time on repeat dosing and any potential differences observed between single and repeat doses.

This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.

This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects.

This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.

Autoimmune PAP is a rare lung disease affecting less than 5,000 individuals in US with no FDA-approved pharmacologic therapy. Results from "off-label" use in case reports and clinical studies completed outside of the US indicate that inhaled rhGM-CSF may be a safe and effective thera-py for autoimmune PAP. Preliminary clinical trials of inhaled rhGM-CSF in autoimmune PAP patients show promising results, 62%-96% therapeutic response rate without any identifiable drug-related adverse effects in at least 73 autoimmune PAP patients. However, the pharmacokinetics (PK), pharmacodynamics (PD), optimal dose, and treatment duration to maximize efficacy are unknown. The goal is to begin to address these knowledge gaps for inhaled sargramostim for autoimmune PAP patients with a pilot safety and PK/PD study (TPSC-110). TPSC-110, PharmPAP, which is a self-controlled open-label, phase I study to evaluate the safety, PK, and PD of inhaled sargra-mostim in autoimmune PAP patients. These results will impact the field by 1) confirming existing published data, 2) monitoring the local effects of inhaled sargramostim in autoimmune PAP patients, 3) potentially demonstrating a safe starting dose for a later trial to evaluate the therapeutic efficacy of inhaled sargramostim for autoimmune PAP.