Clinical Research Directory

A Remotely Conducted 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. This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.

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 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.

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.

A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice

The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.

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).

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

The purpose of this study is to characterize the real-life experience of patients with moderate/severe psoriasis receiving deucravacitinib treatment, in terms of efficacy, safety, and health-related quality of life (HRQoL) in Italy

Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation

The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.

Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)

This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.

Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis

The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

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.

Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study

Psoriasis is a non-communicable chronic immune-mediated disease. Psoriatic skin is characterized by excessive proliferation of skin cells and infiltration of immune cells. The cause of psoriasis is so far unknown. Established therapeutics include topical, oral-systemic, biologic, narrow-band ultraviolet B (NB-UVB). A persistent antipsoriatic effect by the newest biologic therapies has been demonstrated after treatment discontinuation. However, the remittive hallmark of psoriasis suggests the existence of a molecular scar, a kind of disease memory, in clinically healed skin. It has been suggested that this disease memory can be attributed to the tissue-resident memory T (TRM) cell. The main purpose of the study is to investigate whether (NB-UVB) treatment and concomitant Enstilar® treatment can change the amount of TRMs in the skin as well as change the expression in the microenvironment around these cells in the skin from psoriasis patients. In addition, the investigators will investigate whether the treatment can change the quantity and types of other psoriasis-related cells in the skin. In addition to this, the investigators will also examine the effect of treatment on patient-related parameters.

Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden

Psoriasis is a chronic inflammatory disease that affects 125 million people around the world with major repercussions on physical and emotional quality of life of patients. Many studies confirmed the association between psoriasis and comorbidities as cardio vascular diseases, gastroinstestinal, kidney diseases, cancers, infections or mood disorders. Psoriasis, specially, when it is severe, is associated with highest mortality and a disease burden linked to comorbidities. Understanding this disease burden associated to psoriasis is crucial for an optimal medical care. Tildrakizumab is indicated in treatment of moderate-to-severe plaque psoriasis in adults who need a systemic treatment, also, in case of failure, intolerance or contraindication to a systemic treatment, including Methotrexate. The aim of TILFLEX study is to evaluate the efficacy, safety and flexibility of Tildrakizumab in patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg. The main objective is to evaluate the efficacy of Tildrakizumab 200mg at week (W)28.

PsoBest - The German Psoriasis Registry

Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.

A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)

The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people. This trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Tolerate means participants will receive MK-8644 in the trial unless they need to stop it due to health problems.

Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.

The goal of this clinical trial is to learn if topical application of crisaborole 2% ointment can treat flexural and/or genital psoriasis in adult patients of both genders. It will also learn about the safety of crisaborole 2% ointment. The main questions it aims to answer is: * Does crisaborole 2% ointment work effectively in flexural and/or genital psoriasis in adults? * is crisaborole 2% ointment well tolerated in flexural and/or genital psoriasis in adults? * Is crisaborole 2% ointment comparable to tacrolimus 0.1% ointment in terms of efficacy and safety in flexural and/or genital psoriasis in adults? Researchers will compare crisaborole 2% ointment to tacrolimus 0.1% ointment to see if crisaborole works as effective and is as well-tolerated. Participants will: * apply topical crisaborole 2% ointment or tacrolimus 0.1% ointment twice daily for 6 weeks to plaques of flexural and/or genital psoriasis. * Visit the clinic once every 2 weeks for checkups and photography. * Keep a diary of their symptoms.

Impact of Clinical and Psychological Factors on Satisfaction With Treatment in Psoriatic Patients on Biological Therapy

Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.

Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.

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.

Anti Inflammatory Diet With Physical Therapy on Psoriasis

Purpose and Hypotheses The purpose of this study is to find out if changing the diet and adding exercise can help children with psoriasis. Psoriasis is a skin condition that causes red, scaly patches and is linked to inflammation inside the body. We want to see if a special diet that avoids gluten and foods high in histamine can improve children's skin and reduce inflammation. We will also test if adding a fun physical therapy program with light exercise, stretching, and relaxation provides even more benefits, especially for their overall well-being and quality of life. Study Details: Study Duration: 14 weeks in total (this includes a 2-week screening period and the 12-week treatment period). Treatment Duration: 12 weeks. Visit Frequency: Participants will come to the clinic for assessments at the start of the study, after 6 weeks, and after 12 weeks. During the 12-week treatment period, participants in the exercise group will attend supervised physical therapy sessions three times a week. What Will Happen in the Study? Sixty (60) children aged 6 to 17 with mild to moderate psoriasis will be invited to take part. They will be put into one of three groups by chance, like drawing lots. One group will continue with their regular skin care. A second group will follow a special anti-inflammatory diet. This means they will avoid foods with gluten (like wheat bread) and foods high in histamine (like aged cheese or fermented foods) and will eat more fruits, vegetables, and healthy fish. A third group will follow the same diet and also take part in a physical therapy program three times a week. The physical therapy will include light exercise, fun movement activities, and relaxation exercises. Who Can Participate? We are looking for children who: Have been diagnosed with plaque psoriasis for at least 6 months. Have mild to moderate psoriasis. Are not taking any new psoriasis medications. Study Interventions: Dietary Intervention: A structured anti-inflammatory diet that is gluten-free and low in histamine. Physical Therapy: A supervised program of low-impact aerobic activities, stretching, and relaxation exercises. This study is not currently available through an expanded access program.

A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections

The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan. There will be 2 parts to this study. In Part 1, participants are placed in one of 7 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 4 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Group 11 is the only group that will receive multiple doses. Approximately 142 adult participants will be enrolled at approximately 21 sites in the United States and Japan. Participants will be administered one dose or multiple doses of ABBV-547 or placebo. 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.

A Prospective, Interventional, Exploratory Study Evaluating the Efficacy of Small-Molecule Compound XJH05 Ointment in the Treatment of Plaque Psoriasis

Psoriasis is a chronic, recurrent, inflammatory, and systemic disease mediated by immunity, induced by a combination of genetic and environmental factors. Its typical clinical manifestations are scaly erythema or plaques, which may be localized or widespread. It is non-contagious, difficult to treat, and often lifelong. The etiology of psoriasis involves multiple factors, including genetics, immunity, and environment. Through an immune response primarily mediated by T lymphocytes and jointly participated in by various immune cells, it causes hyperproliferation of keratinocytes or inflammation in joint synovial cells and chondrocytes. Psoriasis is an incurable disease; however, numerous therapeutic drugs and methods are currently available. Treatment regimens should be determined based on patient symptoms: mild psoriasis is mainly treated with topical therapies, while moderate-to-severe cases can be managed with systemic therapies. Targeted biologics may be appropriately selected for patients who show an inadequate response to traditional systemic therapies. The goals of psoriasis treatment focus on controlling symptoms and improving patients' quality of life. Psoriasis is classified into different subtypes, among which plaque psoriasis is the most common subtype (accounting for approximately 90%). Among these, about 80% of psoriasis patients have mild disease, with topical drug therapy being the preferred first-line treatment. Currently, commonly used topical agents include vitamin D3 derivatives, glucocorticoids, retinoids, and topical combination preparations. Recent studies have revealed that the interaction between lipocalin-2 (LCN2) and its receptor SLC22A17 plays a key role in the pathogenesis and progression of psoriasis: the LCN2/SLC22A17 axis induces abnormal cholesterol metabolism in keratinocytes by activating the SREBP2 pathway, and acts synergistically with the NLRC4 inflammasome to trigger the release of inflammatory mediators such as IL-1$\\beta$ and IL-18. This chemoselectively recruits and activates neutrophils, establishing a continuously amplified inflammatory cascade. Notably, direct inhibitors or antagonists targeting the SLC22A17 receptor have not been fully developed in existing technologies, and reports regarding the molecular structures, selectivity, and druggability of relevant compounds remain rare. Most studies are still confined to preliminary exploration via genetic intervention or antibody blockade, lacking molecular entities that can be translated into clinical applications. By screening and validating the potential of the specific small-molecule compound XJH05 to achieve upstream intervention in psoriasis by targeting SLC22A17, we aim to provide a therapeutic solution for psoriasis that possesses both mechanistic innovation and clinical feasibility. This small-molecule drug can specifically bind to the active site of the SLC22A17 protein, blocking the interaction between SLC22A17 and LCN2. Consequently, it inhibits the activation of the LCN2-SREBP2-NLRC4 signaling axis and downregulates the expression of pro-inflammatory cytokines, thereby blocking at the molecular level both the pathological hyperproliferation of epidermal keratinocytes and the infiltration of immune cells such as neutrophils, which are characteristic features of psoriasis. Although numerous drugs and therapeutic methods are currently available for psoriasis, it remains an incurable disease. Through animal experiments and in vitro drug interventions on psoriasis patient skin lesions, we have demonstrated that the small-molecule drug XJH05 is safe, effective, and free of adverse reactions; however, clinical data regarding XJH05 ointment in the treatment of patients with plaque psoriasis are still lacking. Therefore, we plan to conduct a prospective, interventional, exploratory study on the efficacy of XJH05 ointment in treating plaque psoriasis, hoping to provide further evidence regarding the therapeutic efficacy of XJH05 ointment in the psoriasis patient population.

A Study of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults

The goal of this intervention study is to assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Participants. The main parameters it aims to answer are: Does a single dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in healthy participants impact the Safety, Tolerability, Pharmacokinetics, and Immunogenicity profiles? This study will be a randomized, double blind, placebo-controlled study.