View clinical trials related to Psoriasis.
Filter by:Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored. Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally. The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
A 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.
This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.
Background: Heart failure (HF) is a public health burden. Studies have shown a link between inflammation, myocardial dysfunction, and HF. Researchers want to use psoriasis as a disease model of chronic inflammation to further study the link between inflammation and myocardial dysfunction. Objective: To learn if chronic inflammation affects the heart and if taking a biological medicine for chronic inflammation helps improve how the heart works. Eligibility: Adults ages 18 and older who have moderate to severe psoriasis, and healthy adult volunteers. Design: Participants will be screened with a medical history. They may take a pregnancy test. Healthy volunteers will have 1 visit. Those with psoriasis will have a second visit 1 year later. Participants may give blood samples. They may have a heart function test. They may have a heart imaging test, and may get a contrast agent. If so, it will be injected into a vein. Participants may have positron emission tomography/computed tomography tests. They will lie on their back on a padded table with their arms straight overhead. They may get radioactive drugs through an intravenous (IV) catheter. They will get stress medicines through the IV. These drugs mimic exercise and increase blood flow through the heart. Participants may have cardiac magnetic resonance imaging. The scanner is a large tube. Participants will lie on a table that slides in and out of the tube. They will get gadolinium contrast in a vein to improve the pictures. They may get stress medicines. Coils will be used to help make the pictures. Participation for healthy volunteers will last 1-2 days. Participation for those with psoriasis will last 14 months. ...
Background: The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response. Objective: To learn about how the immune system and skin healing are related to each other. Eligibility: People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed. Design: Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test. Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions. Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil. Participants will give at least 1 blood sample. Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm. Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed. Participants may give leftover samples taken as part of their regular medical care. Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977. Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide. Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Psoriatic Arthritis is an inflammatory condition that typically affects joints and soft tissues such as tendons. Poorly controlled or untreated psoriatic arthritis can lead to joint damage, disability and poor physical and mental wellbeing. Evidence suggests that early diagnosis and treatment of psoriatic arthritis can minimise adverse health outcomes. Musculoskeletal ultrasound has become an extremely useful tool in aiding rheumatologists to diagnose inflammatory joint conditions particularly at an early stage in the course of a disease. Psoriatic arthritis is known to affect up to 30% of patients with skin psoriasis. Therefore, national dermatology guidelines advise that patients with skin psoriasis should be asked about any joint symptoms at least every year. This study investigates whether skin psoriasis patients who are not on biologic treatment are indeed being asked about any joint symptoms and we subsequently invite patients for a musculoskeletal ultrasound scan to see if they have features of early psoriatic arthritis on ultrasound. Those who do are then invited for a thorough rheumatology clinical assessment.
A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis (INDUS-3)
Background Psoriasis is a common disease which is a source of major distress for patients and costs for the society. Treatments are effective but temporary and relapses occur, preferentially at sites previously involved. Locally, tissue resident memory T cells (TRM) cells prone to produce pathogenic cytokines accumulate in the outer layers of the resolved skin of psoriasis patients under treatment, and can trigger strong inflammatory responses upon reactivation, thus starting the cascade of the relapse. We have recently shown that the skin transcriptional responses after TRM cell activation in healed skin biopsies of patients could predict the time until the disease relapse. How to modify the local pool of TRM cells in the human skin is not known, but several factors leading to the establishment and the persistence of the TRM cells in the skin are suggested. First, the skin microbiota has emerged as a potent actor of the skin immunity, with the capacity to shape the pool of skin T cells in mice. Second, after TRM cells are settled in the skin, their lipid intake will impact their local survival. Last, in addition to these local factors, the gut subclinical inflammation that lead to bacterial translocation can trigger a more global state of inflammation in the body and could drive the local survival of the TRM cells in the skin. Aims Our first aim in this project is to validate a tool to predict psoriasis relapse upon treatment withdrawal in a cohort of patients treated with systemic drugs- the STOPso cohort (Shortening Treatments Of Psoriasis). We will correlate the skin reaction to local TRM activation in resolved lesions to the time before relapse. In parallel, we will characterize several factors likely to participate to the establishment, function and survival of the TRM cells in the skin. We will decipher the skin microbiota and mycobiota; the lipid composition of the outer layer of the skin; the presence of lipopolysaccharide in the blood, in order to better understand what factors should be targeted to modify the skin populations of TRM cells. Methods Patients will be recruited through the Dermatology department of the university hospital of Besançon. We will use skin biopsies from resolved lesions to perform the characterization of the skin responses at the transcriptional level after local TRM activation with OKT-3 antibody compared to control. RNA will be analyzed with Nanostring technologies. For the microbiota analysis, we will use wet swabs and later DNA sequencing. The lipid composition and the circulating LPS will be analyzed after tape stripping, through the LabEx LipSTIC lipidomic platform of the region Bourgogne Franche-Comté. Patients will be followed up at Month 1, Month 6, Month 12 and Month 18 and at time of relapse if it occurs in between those intervals. Data about the disease activity (PASI, quality of life scores) and inter-current events will be registered at each time point. Expected results and Perspectives The final aim of this project is to validate a tool available to clinicians to guide them in their decision to withdraw an efficient treatment in psoriasis, based on the skin reactivity to the resident T cells left locally after resolution of the inflammation. This would help reduce treatment length, and thus toxicities and costs to the health care systems. To open future perspectives, we also want to better understand the reasons why TRM populations tend to be retained in the skin, in order to develop remodeling strategies of the skin TRM populations.
Widely expressed in the sensory nerve endings of the skin, Transient Receptor Potential Vanilloid 1 (TRPV1) is a receptor that plays an important role in the perception of pain and pruritus but also in skin inflammation, primarily by inducing the local release of several neuropeptides. Although the mechanisms by which TRPV1-sensitizing inflammatory mediators in damaged skin have received considerable attention, the role of TRPV1 in psoriasis has so far been little explored. However, two studies have reported that ablation of sensory nerves expressing TRPV1 reduced psoriasiform skin inflammation, demonstrating the neuronal contribution to inflammation in psoriasis. However, the expression of TRPV1 is not limited to neurons alone. TRPV1 is also expressed by epidermal keratinocytes and skin microvessels. For example, in 2018, transcriptomic analysis of psoriatic patient skins (by definition devoid of neuron nuclei) revealed that TRPV1 expression was increased in the skin of psoriatic patients suffering from itching (pruritus). Regarding human keratinocytes, it is recognized that the activation of TRPV1 present on their surface induces the release of pro-inflammatory factors such as cyclooxygenase-2. In addition, the investigators have demonstrated that TRPV1 has a pivotal role in the keratinocyte production of inflammatory mediators, which is mediated by the protease-activated receptor-2 (PAR-2). However, the role of vascular TRPV1 in inflammation is not described. The investigators hypothesize that in addition to neuronal TRPV1, non-neuronal TRPV1 receptors of non-neuronal cells (keratinocytes and endothelial cells) may be involved in the vicious circle of the inflammatory process characteristic of psoriasis. Putting TRPV1 at the center of the deregulation of the homeostatic balance including epithelial, neuronal and vascular inflammation in psoriasis is totally innovative.