Clinical Research Directory

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.

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.

Risankizumab Long-term Remission Study

Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial conducted by us (Laboratory for Investigative Dermatology at the Rockefeller University) was groundbreaking that just a single dose of anti-IL-23p19 antibody (risankizumab, trade name: Skyrizi, study drug in this clinical trial) administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. However, there is a lack of understanding about immune regulation in human skin induced by anti-IL-23p19 antibody injection, and there is a need to conduct a psoriasis clinical trial for single-cell sequencing immune cells in human psoriasis skin before and after anti-IL-23p19 antibody administration, and to correlate regulatory immune cell alterations with clinical disease progression. The overall objective of the clinical trial is to study regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in psoriasis patients who achieve long-term disease clearance off drugs.

Cytokine Expression in Psoriasis Patients With and Without Joint Involvement

The objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. This research will compare cytokines levels in sera, in PBMC culture after LPS or CD3/CD28 agonist antibodies, and in skin biopsy.

Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.

Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors

This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.

A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis

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....

Methotrexate Versus Apremilast for Pruritus in Psoriasis

This randomized controlled trial aims to compare the efficacy of Methotrexate versus Apremilast in reducing pruritus and improving quality of life in patients with psoriasis. Eighty patients aged 20 to 60 years with psoriasis involving more than 8% body surface area and associated pruritus will be enrolled and randomly assigned into two groups. Group A will receive oral Apremilast titrated to 30 mg twice daily, while Group B will receive oral Methotrexate 10 mg once weekly for 8 weeks. The primary outcome will be change in Dermatology Life Quality Index (DLQI) score at 8 weeks. Secondary outcomes include change in numerical rating scale for pruritus and assessment of adverse effects. The study will be conducted at Pakistan Emirates Military Hospital Rawalpindi.

A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

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.

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.

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 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.

Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

This is a randomized, double-blinded, controlled Phase I study of new process CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of new process CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.

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 Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin disease characterized by erythematous, scaly plaques that may be associated with pain and pruritus, in routine clinical practice.

Machine Learning-Based Prediction of Insulin Resistance in Psoriasis Patients Emphasizing Interpretability

Psoriasis is a long-term inflammatory skin disease that can affect overall health. People with psoriasis have a higher risk of developing insulin resistance, a condition in which the body does not respond properly to insulin. Insulin resistance can increase the risk of diabetes, heart disease, and other serious health problems. Because insulin resistance often develops without clear symptoms, many patients are not diagnosed early. The purpose of this study is to identify which patients with psoriasis are more likely to develop insulin resistance and to create a tool that can help doctors estimate this risk for individual patients. The study will use existing medical records from two medical centers. Researchers will analyze information such as age, body weight, psoriasis severity, blood test results, other medical conditions, and medication history. Machine learning methods will be used to analyze these data and build a prediction model. The model will be designed to be easy to understand, so doctors can see which factors contribute most to insulin resistance risk. This study does not involve any new treatments or procedures. All patient information will be anonymized to protect privacy. The results may help doctors identify high-risk patients earlier and support timely monitoring and preventive care.

Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis

The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis. It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis. The main question it aims to answer is: In subjects with moderate to severe plate psoriasis treated with CMAB015, Is the proportion of patients achieving a 75% improvement in PASI (Psoriasis area and severity index) scores relative to baseline (PASI 75) the same as those treated with Secukinumab? Participants will: Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 48. Visit the clinic at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 52. Be evaluated with PASI scores, body surface area (BSA) scores and investigator's global assessment (IGA) (mod 2011) scores.

Improving Disease Severity

Phototherapy, including ultraviolet B (UVB) and ultraviolet A (UVA) light, has been used to treat a number of dermatologic conditions. Psoriasis is one of the most common conditions treated with phototherapy, in which phototherapy is often indicated for extensive disease with contraindications for other systemic treatments. The mechanism of action of phototherapy for the treatment of psoriasis is not completely understood; however, it is known that UVB light induces apoptosis of pathogenic T cells and keratinocytes, which may reduce the overactive immune response and epidermal hyperproliferation. Phototherapy has shown some efficacy for other diseases, such as alopecia areata (AA) and polymorphous light eruption (PMLE). However, phototherapy is not always an accessible treatment option for patients due to cost or lack of time.

Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus

The product RL3020-DP0364 developed by Pierre Fabre Laboratories moisturizes durably and repairs dry or atopic skin, especially in the case of certain dermatoses (atopic dermatitis, ichthyosis, etc ...) and erythema induced by radiotherapy. Its unique formula treats the symptoms of dry skin by creating a protective film that prevents dehydration and helps protect the skin from external aggressions. Through this study, the efficacy of this medical device will be evaluated specifically in subjects presenting stable psoriasis, dry skin and pruritus with an application on the whole body (excluding the head).

Assessing Psoriasis Treatment Outcomes

To assess the feasibility of AIGPP video interactions with psoriasis patients. To explore patient attitudes, trust, and comfort levels concerning AIGPP interactions in a healthcare setting, and to understand their influence on the patient-physician dynamic. To evaluate medication adherence over a 4-week period in patients with psoriasis randomized to weekly AI-generated automated physician providers (AIGPP) video interactions, weekly human video calls, or standard care (single follow up visit after 4 weeks). Adherence rates will be evaluated via a cap designed to record adherence attached to the study medication container.

Impact of Hand Rub Placement on Patient Trust and Disease Stigma

This study aims to investigate how the physical placement of hand sanitizer in consultation rooms affects patient trust and feelings of disease stigma. While hand hygiene is an essential infection control measure in healthcare, performing it immediately in front of patients with visible, non-communicable conditions (such as psoriasis) might inadvertently make patients feel rejected or stigmatized.This study uses a randomized controlled design to evaluate if a simple environmental modification-changing the spatial location of the hand sanitizer-can naturally nudge physicians to alter their hand hygiene timing without compromising safety. Researchers will discreetly observe the hand hygiene behavior of outpatient dermatologists and ask participating psoriasis patients to complete a brief, anonymous questionnaire regarding their trust in the physician, feelings of stigma, and overall satisfaction with the consultation. The goal is to provide evidence for patient-centered hospital space designs that protect patient psychological well-being while maintaining hygiene standards.

Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.