Clinical Research Directory

The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)

Background: \- Cardiometabolic diseases are medical disorders that can occur together and affect the heart. They increase the risk of developing heart disease and diabetes. One disorder, psoriasis, is an inflammation that mostly affects the skin but can affect the entire body. Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited on the wall of arteries. This causes arteries to harden and become less flexible. Many cells that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship between cardiometabolic diseases and psoriasis. Objectives: \- To study the relationship between psoriasis and cardiometabolic diseases. Eligibility: \- Individuals at least 18 years of age who have psoriasis. Design: * Participants will be screened with a physical exam and medical history. * Participants will have up to seven outpatient visits over the 4 years. The first visit will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5, will be scheduled yearly for the next 3 years. If participants have a psoriasis flare with more severe symptoms, they may have an extra visit. Those who leave the study early will have a final visit with the full series of tests. * At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and medical history. They will provide blood and urine samples, as well as optional tissue biopsies. They will also have heart function tests. Imaging studies, as well as optional photographs of affected areas, will be performed. These tests will also be performed at the final visit. * At visits 3 and 4, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

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. ...

Anti-Inflammatory Effects of Time-Restricted Feeding

Background: Time-restricted feeding (TRF) means that a person eats only during certain hours of the day. In other studies, researchers have found that fasting can improve immune system function in healthy people. They want to see if TRF has the same effect on people with psoriasis. Objective: To test whether TRF can change metabolism and decrease some markers of inflammation in the blood of people with mild to moderate psoriasis. Eligibility: Males ages 18 to 80 with mild to moderate active psoriasis, and healthy volunteers Design: Participants will be screened with a medical history and medicine review. They will have a physical exam and blood tests. Their skin will be examined. They will have a nutritional evaluation. Their resting energy expenditure will be measured. For this, a clear plastic ventilation hood will be placed over the head for a short time. Participants will stay at the NIH Clinical Center for 4 1/2 days. They can watch TV, do work, do schoolwork, and other quiet activities. A small sensor will be placed under participants skin to measure blood glucose. For part of the study, participants will be housed in a small room called a metabolic chamber. They will wear a heart monitor. Participants will walk on a treadmill for 30 minutes each day at a comfortable speed. For 3 days, participants will eat all their daily calories between 8 am and 2 pm. They will fast for the other 18 hours of the day. They can drink water. Participants will complete mixed meal tests. They will drink a liquid meal for breakfast. Then they will give blood samples via intravenous (IV) catheter. Participation will last for 5 days....

Skin Microbial Ecology in Atopic Dermatitis

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis \[AD\]) have much higher concentrations of a certain bacteria (S. aureus), especially when their disease is active but little is known about the role that this bacteria plays in psoriasis (i.e. disease severity, biomarkers and skin barrier function). The overarching purpose of this longitudinal study is to understand how the abundance of skin S. aureus (and several commensal bacteria) change as a consequence of standard of care treatment in the URMC dermatology clinics. Other assays and biospecimens will also be collected to address a number of questions.

A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis

A Study looking at the safety and efficacy of D-2570 in Participants with Plaque Psoriasis

SEquential Treatment of PSoriasis With Biologics

Psoriasis is a common skin condition that leads to patches of scaled skin which can be inflamed, sore and itchy. It can affect any area of skin on the body, as well as nails, and can be widespread and severe. Over the past 20 years, many new treatments have been developed and approved for severe psoriasis. Most of these newer treatments are given by injection and, as a group, are known as biologics. Many people respond well to biologics and have a meaningful improvement in their condition. There is a smaller proportion of people who do not respond well, or develop side effects, and so must switch drugs to try and improve their condition. In some cases, people need multiple lines of biologic treatment. Currently very little is understood about how well people respond when they are treated with three or more biologics in a row, as very few trials have been done in these cases. This study aims to use data from people who have already been treated with biologics by their Dermatology teams in the NHS and use the information obtained during their normal clinic appointments to investigate this question. The investigators will assess how well people respond to each line of biologic drug (1st to 10th). They will look at whether people respond as well or less well over time, the more biologics they have. People can be included in the research if they are 18 or over and have been treated with a biologic for psoriasis in participating hospitals in the NHS in England. In this study the investigators are assessing data from events that have previously happened, and so no extra visits are required

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.

A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania

This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.

Psoriasis Longitudinal Assessment and Registry

The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis. The study also includes patients receiving other therapies, such as non-biologic and other biologic agents. The registry also evaluates patient and disease characteristics, including patient-reported assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.

A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology

The goal of this clinical trial is to evaluate whether an electronic patient-reported outcome measure (ePROM)-guided flexible scheduling system can improve outpatient clinic resource utilisation in patients attending dermatology outpatient clinics for routine follow-up. The main questions it aims to answer are: * Does the intervention reduce the number of actualised outpatient visits over 12 months compared with standard fixed scheduling? * Does the intervention group achieve higher adherence to monthly ePROM monitoring, as measured by the proportion of completed ePROM submissions?

Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients

Skin diseases, despite low mortality, significantly impair quality of life. This randomised controlled trial evaluates the efficacy of a digital toolkit comprising psychotherapeutic strategies in reducing QoL burden in patients with chronic inflammatory skin conditions. This toolkit is hosted on a mobile application and will be used by study participants randomised to the intervention arm over the 32 week study period.

Safety and Efficacy of CBP-0276 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects

Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of CBP-0276 in dose of 200mg twice dose a day, or placebo administrated for 36 weeks to improve Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score ≥1, Dermatology Life Quality Index (DLQI) 0/1 at Week 6,12,18,24, 30 and 36 among patients with baseline DLQI ≥2, adjusted by transcriptomics profile (post-hoc analysis), Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a ≥4-point reduction from baseline) at Week 4 and 8, Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10).

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Effectiveness of a Digital Health Application for Psoriasis

This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis. Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.

Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet

Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients. Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet.

Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are chronic inflammatory diseases within the spectrum of spondyloarthritis, characterized by immune-mediated inflammation and progressive functional impairment. Meteorin-like protein (Metrnl) is a novel adipomyokine with potential immunomodulatory and anti-inflammatory properties; however, its role in spondyloarthritis remains incompletely understood. This study aims to evaluate serum Metrnl levels in patients with PsA and AS compared with healthy controls and to investigate their association with disease activity, inflammatory markers, and clinical manifestations. The findings may provide insights into the potential role of Metrnl as a biomarker of disease activity and inflammation in spondyloarthritis.

Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases

Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases. The main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases. The secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.

Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis

To evaluate the long-term efficacy of two maintenance treatment patterns of secukinumab-the standard maintenance group and the non-standard maintenance group-by assessing the median time to onset and incidence of secondary failure, as well as the time to regain response after dose escalation of secukinumab (including re-initiation of intensive dosing or shortening of the injection interval) in patients who experienced secondary failure.

A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

Emerging evidence indicates that psoriasis and eczema can coexist in the same patient, with reported co-prevalence rates ranging from 0.17% to 20%, suggesting that these conditions may represent a disease spectrum-referred to as Psoriasis Eczema (PsEma). Moreover, paradoxical eczema has been observed in approximately 1% to 12.1% of psoriasis patients undergoing biologic therapy, with up to 61% of affected individuals discontinuing treatment due to eczematous flares. These findings underscore an urgent need for therapeutic agents that are efficacious for PsEma. Tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) family, is known to mediate critical signaling pathways involved in psoriasis pathogenesis, including those of type I interferons, interleukin (IL)-12, and IL-23. Additionally, TYK2 forms heterodimers with other JAK family members-such as JAK1 or JAK2-to transduce signals from cytokines like IL-13 and IL-22, which are centrally implicated in the pathophysiology of eczema. Based on this molecular profile, we hypothesize that TYK2 inhibition may not only avoid inducing eczematous reactions in psoriasis patients but may also alleviate eczematous inflammation by interfering with JAK1(JAK2)/TYK2-mediated IL-13 and IL-22 signaling. Deucravacitinib, a selective allosteric TYK2 inhibitor, has shown promising results in our clinical practice, demonstrating improvements in both psoriatic and eczematous manifestations among patients with PsEma. This study aims to prospectively evaluate the efficacy and safety of deucravacitinib in PsEma patients over a 16-week treatment period. In parallel, transcriptomic profiling of peripheral blood and lesional skin will be performed to elucidate the immunological landscape and molecular signatures underlying PsEma, thereby contributing valuable clinical and mechanistic insights into its diagnosis and management.

The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease

The goal of this clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions: 1. Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity? 2. Are changes in dietary sodium are associated with changes in skin sodium concentration and atopic dermatitis and psoriasis severity? Researchers will compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake. Participants will: * Follow a low-salt diet for the duration of the 13-week study * Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa * Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI

Trial of HSK44459 Cream for the Management Plaque Psoriasis

Phase I Study Objectives: * Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis. * Secondary: Evaluate the pharmacokinetic (PK) profile of HSK44459 cream in the same populations (healthy adults and plaque psoriasis patients). Participant Allocation: \- 10 healthy adults and 10 plaque psoriasis patients are enrolled. Participants are randomized to either the HSK44459 cream group (8 per population) or the vehicle (placebo - like) control group (2 per population). Treatment Schedule: * Day 1: Single - dose administration (one application). * Days 2-3: Washout period (no medication). * Days 4-9: Twice - daily administration. * Day 10: One application. Phase II Study Objectives: * Primary: Conduct a preliminary evaluation of the efficacy of HSK44459 cream in treating plaque psoriasis. * Secondary: Assess the safety and tolerability of HSK44459 cream in plaque psoriasis patients. Evaluate the PK profile of HSK44459 cream in plaque psoriasis patients. Participant Allocation: \- 160 plaque psoriasis patients are enrolled and randomized in a 1:1:1:1 ratio to four groups: 1% HSK44459 cream (40 patients), 0.3% HSK44459 cream (40 patients), 0.1% HSK44459 cream (40 patients), or vehicle control (40 patients). Treatment Schedule: Phase II: The study consists of three phases (screening, treatment, and follow - up) * Screening Period (D - 28 to D - 1): Eligible plaque psoriasis patients sign an informed consent form and complete screening assessments to establish baseline data. * Treatment Period (W1D1 to W9D1 ± 3 days): After baseline evaluation, eligible patients are randomized. The first dose of the study drug is administered on W1D1, with twice - daily dosing for 8 weeks. Patients return to the study center at W3D1 ± 3, W5D1 ± 3, W7D1 ± 3, W9D1 ± 3, and W11D1 ± 3 for scheduled assessments and procedures. * Follow - up Period (W9D1 ± 3 days to W11D1 ± 3 days, within 14 days after the last dose): Adverse events and concomitant medications are collected. A final safety visit (W11D1 ± 3 days) includes additional assessments and procedures. In summary, this trial aims to comprehensively evaluate HSK44459 cream's potential as a treatment for plaque psoriasis, while also characterizing its safety, tolerability, and PK properties in both healthy individuals and patient populations.