Clinical Research Directory

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.

Retinal Capillary Vessel Density and Foveal Avascular Zone Size in Patients With Psoriatic Arthritis: A Case-Control Study.

In terms of blood flow per unit of tissue, the retina is one of the tissues with the highest blood flow in the body. Parameters such as the thickness of the choroid layer, which plays a crucial role in maintaining normal eye function, the dimensions of the foveal avascular zone (FAZ) supplied by this layer, and retinal vascular networks can be measured using non-invasive methods. OCTA (Optical Coherence Tomography Angiography) is an imaging tool that enables the non-invasive assessment of retinal microvascular densities and the measurement of the foveal avascular zone's dimensions. Studies conducted to date indicate that retinal capillary vessels and the dimensions of the foveal avascular zone are affected in rheumatological diseases, especially associated with systemic inflammation. This study aims to compare retinal capillary vessel density and foveal avascular zone dimensions in patients with psoriatic arthritis against those in a healthy population and in patients with psoriasis who do not have psoriatic arthritis, utilizing the non-invasive method of optical coherence tomography angiography.

Online Therapist-guided Receptive Music Therapy in Adults With Psoriasis

This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and clinically relevant psychological or quality-of-life burden. Seventy-five participants were randomized in a 1:1:1 ratio to treatment as usual, treatment as usual plus an audio-based active relaxation control, or treatment as usual plus therapist-guided receptive music therapy. The principal comparison was between the music therapy and active control groups. Dermatology-specific quality of life, perceived psychological stress, anxiety, and depressive symptoms were assessed at baseline, at the end of the four-week intervention, and at three and six months after the intervention. Dermatological severity, treatment adherence, intervention adherence, and other prespecified or documented exploratory measures were also assessed. Alcohol, drugs and nicotine-use information, as well as the Revised Illness Perception Questionnaire 9, are reserved for a distinct secondary exploratory analysis and are not part of the primary efficacy evaluation.

A Study to Assess Deucravacitinib Safety in Pregnancy

The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists \[OTIS\]) who were exposed to deucravacitinib.

Global Healthcare Study on Psoriasis

The Global Healthcare Study on Psoriasis (GHSP) is an international, multicenter observational study hosted by the University of Zurich (UZH) investigating healthcare access, treatment patterns, disease severity, and quality of life in patients with psoriasis. The study collects standardized clinical data from routine medical records to identify disparities in healthcare delivery and outcomes across different healthcare systems.

Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada

This is a multi-centre, non-interventional, open-label, prospective observational study that will be conducted across Canada over 52-week duration. Approximately 80 patients who are initiating tildrakizumab as part of their routine care through the ILUMYA SUPPORT® Program and meet the study's eligibility criteria will be enrolled. Specifically, the study will enroll patients with Fitzpatrick scale skin types III and above. The real-world impact, safety and effectiveness of tildrakizumab on patients with moderate-to-severe plaque psoriasis (PsO) remain largely undocumented in Canada, despite its approval in 2018. Given Canada's diverse population, this study presents an opportunity to evaluate tildrakizumab's quality of life, safety and effectiveness in specific demographic groups, particularly those patients with Fitzpatrick scale skin type III and above. The findings from this study will help optimize care, address unmet needs, and ensure that treatment outcomes are inclusive and reflective of Canada's diverse population.

A Clinical Trial of Antiplatelets in Psoriasis

The purpose of this study is to determine the effect of antiplatelet therapy on the endovascular phenotype in psoriasis, specifically whether clopidogrel reduces vascular endothelial pro-atherosclerotic transcript expression more than aspirin or placebo. The primary endpoint is mean change in a composite endothelial pro-inflammatory/pro-atherosclerotic transcript expression signature measured from brachial vein endothelial cells.

A Study of HL40626S Tablets in Healthy Adults

This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.

The Effects of Audio-Based Therapy on Anxiety in Psoriasis

Anxiety in psoriasis is associated with impaired quality of life, and the prevalence of anxiety symptoms in psoriatic populations is approximately 34% and anxiety disorders up to 16%. Many experts recommend routine screening, referral, and interventions for anxiety in psoriasis; however, many barriers inhibit access to mental health resources and proper management. To our knowledge, there is a lack of easily accessible interventions that manage anxiety. Audio-based therapy offers convenient and effective interventions that show reduced anxiety in published, randomized studies and is a promising management for psoriasis patients. This study will evaluate the effects of audio therapy in patients with psoriasis and measure changes in overall symptoms.

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.

Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis

To assess the effectiveness of topical tapinarof to topical betamethasone in patients with mild to moderate plaque psoriasis presenting to tertiary care hospital in Islamabad

Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)

The RiseFast pilot study will investigate the clinical, metabolic and immunological effects of fasting and plant-based diet (PBD) on patients with psoriasis (PsO) and psoriatic arthritis (PsA) on their gut microbiota. The project will combine clinical assessments, cytometric profiling, and gut microbiota analysis to explore the relationship between fasting, a plant-based diet, and psoriatic disease. The study includes a 7-day fasting period followed by 11 weeks of PBD, with the goal of improving disease activity, quality of life, and understanding the role of gut microbiota in these conditions. This approach could lead to low-cost, accessible therapeutic options with minimal side effects.

Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease

This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).

Inflammation Digital Biomarkers Validation Study

HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. The study is led by a research team at University of Oxford and supported by a team at University College Dublin. This current study aims to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. The investigators want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. The HPOS study is currently recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires include a 'screening questionnaire' to try to identify arthritis. Adults with psoriasis but without a pre-existing diagnosis of PsA are currently being recruited via clinics, national and international patient support organisations including those under the umbrella of EUROPSO, and media campaigns. Participants are recruited across Europe in the following countries: UK, Ireland, Italy, France, Spain, Denmark, Germany, Belgium, Netherlands, Sweden, Portugal, Greece, Norway, Switzerland, Poland and Romania. The University of Oxford is the sponsor for the study across all countries, but local regulations will be followed, and local ethical approval has been sought for each different country. Data is requested from participants every 6 months and they will be prompted by email. Likewise, the iPROLEPSIS consortium is a Horizon Europe funded consortium investigating digital biomarkers in PsA. In 2024, the consortium launched a study recruiting 600 patients with PsA across 4 counties, utilising digital biomarkers to identify disease flares. This includes the use of smartwatches, a mobile phone app and active video tests. This will allow us to develop algorithms to identify active disease. Similar approaches are proposed for a study called the Inflammation Digital Biomarkers Study (IDBV) which will try to identify the onset of PsA in people living with psoriasis. Patients in HPOS who have given consent to be contacted about additional studies, will be offered the opportunity to join this study. They will complete an additional consent form and will download the miPROLEPSIS lite app to their mobile phone. The Study app will passively collect data from the user's phone; participants do not need to perform any specific tasks apart from some initial configuration steps like logging in and connecting their wearables (Connecting a wearable is optional). The investigators intend to run IDBV as a sub-study in HPOS and invite participants enrolled into the HPOS study who do not have a diagnosis of PsA.

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are: 1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab? 2. Do in-person or virtual visits work better? Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version. Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.

Psoriasis Comorbidities at Hospital Calderón Guardia

The goal of this observational study is to characterize the epidemiologic, clinical, severity, and therapeutic features of patients with psoriasis treated in Costa Rica between 2024 and 2025. The main questions it aims to answer are: What are the demographic and clinical characteristics and severity profiles of psoriasis patients? What treatments are used in routine clinical practice, and how are they associated with disease severity and outcomes? Patients with psoriasis receiving dermatologic care during the study period will be included. Data will be obtained retrospectively from electronic medical records and clinical registries without intervention or modification of treatment.

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are: * Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice? * What is the safety profile and treatment persistence of IL-23 inhibitors in this population? * Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.

Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis

This study will evaluate the effects of oral semaglutide in combination with topical corticosteroid/calcipotriol on clinical outcomes and metabolic inflammation in patients with plaque psoriasis and overweight/obesity and/or type 2 diabetes mellitus. A total of 62 participants will be randomized to receive either semaglutide plus topical corticosteroid/calcipotriol or placebo plus topical corticosteroid/calcipotriol for 12 weeks. Clinical efficacy will be assessed using the Psoriasis Area and Severity Index (PASI), and quality of life will be evaluated using DLQI, PROMIS-29, and EQ-5D-5L. Systemic inflammatory markers will also be measured to assess metabolic inflammation.

Research on the Extraction of Tongue and Facial Diagnosis Features of Psoriasis Vulgaris in Traditional Chinese Medicine and Its Correlation With Laboratory Indicators

Psoriasis Vulgaris is a chronic, inflammatory, and immune-activated skin disease. It is the most common type of psoriasis, accounting for approximately 85-90% of all psoriasis patients. Its clinical features include erythema, papules, covered with varying scales, a long course of disease, and recurrent attacks. According to traditional Chinese medicine, psoriasis is mainly characterized by blood heat syndrome, blood stasis syndrome and blood dryness syndrome, accounting for more than 90% of all syndrome types. The TCM syndrome differentiation and treatment of psoriasis also attach great importance to the transformation and evolution of TCM syndrome types. For instance, the three syndrome types of blood heat syndrome, blood stasis syndrome and blood dryness syndrome are not static and can transform into each other. For example, blood heat syndrome can develop into blood dryness syndrome as the disease progresses, blood dryness syndrome can transform into blood stasis syndrome, and blood stasis syndrome can also transform into blood heat syndrome or blood dryness syndrome. Observation is an important diagnostic method in traditional Chinese medicine. The images of tongue and face diagnosis contain a lot of important clinical information. They can objectively reflect the prosperity and decline of qi and blood in the human body, the nature of diseases, the depth of the lesion location, the prognosis of the disease, and can also reflect the physiological and pathological changes of the body. In recent years, significant progress has been made in the research of digital and intelligent technologies for tongue and facial diagnosis. Introducing objective indicators such as tongue diagnosis, facial diagnosis and pulse diagnosis into the evaluation research of diseases has become a hot topic. This project, by analyzing the clinical tongue and facial image data of patients with psoriasis vulgaris and combining it with clinical laboratory indicators, fuses and analyzes the characteristic parameters of patients' tongue and facial diagnosis with blood biochemical indicators, metabolomics and other data. This is helpful to reveal the disease occurrence pattern of patients with blood stasis type psoriasis and construct a diagnostic model for blood stasis syndrome of psoriasis. At the same time, it provides a powerful decision support tool for clinical practice and also helps deepen our understanding of the complex process of the occurrence of blood stasis type psoriasis, thereby providing a solid scientific basis for formulating precise diagnostic and treatment strategies.

Physician- vs Questionnaire-Based Screening for Psoriatic Arthritis in Psoriasis

Early diagnosis of psoriatic arthritis (PsA) requires close collaboration between dermatologists (as the skin manifestations of psoriatic disease in most cases precede the musculoskeletal manifestations) and rheumatologists (who are usually responsible for the final diagnosis of PsA and treatment of the musculoskeletal manifestations). Previous epidemiological studies suggest that there may still be a significant proportion of undiagnosed PsA patients among those with psoriasis seen by a dermatologist. At the same time, a diagnostic delay of more than 6 months contributes to poor radiological and functional outcomes in PsA patients. Several screening tools / questionnaires (including the Psoriatic Arthritis Screening Evaluation - PASE, the Toronto Psoriatic Arthritis Screen - ToPAS and its further development - TOPAS 2, the Psoriasis Epidemiology Screening Tool - PEST, and the Early Psoriatic Arthritis Screening Questionnaire - EARP) have been developed and validated in the past decades - all relying mostly on symptoms reported by a patient with psoriasis without an evaluation / confirmation of the presence of musculoskeletal symptoms by a dermatologist. The CONTEST study, which compared three screening tools (PASE, ToPAS and PEST) in a secondary care setting, determined that they all had a good probability of detecting PsA (sensitivity of approximately 80%) but had poor specificity (approximately 35%). Further analysis of the results of the above study has identified the most discriminative questions from each of the three questionnaires, including questions about the back and neck, and these items have been combined to create a new single 8-item screening questionnaire (CONTEST). However, a subsequent study demonstrated a similar performance for the CONTEST and the PEST tools. This poor specificity means that screening questionnaires are often not used in practice and raises a risk of overwhelming rheumatology referrals. In a recent survey of GRAPPA members, most of the participants (consisting of dermatologists, rheumatologists, and patient research partners), suggested that a basic evaluation of MSK symptoms by a dermatologist in addition to the patient-reported symptoms (questionnaire) should be part of the screening / referral process. We hypothesize, therefore, that adding a MSK evaluation by dermatologist in the screening process will be able to improve the outcome of the screening and referral process in relation to the PsA detection. In this study, we plan to evaluate the performance of a physician (dermatologist)-based screening and referral strategy as compared to the strategy based on a questionnaire completed by a patient for the detection of patients with a high probability of a diagnosis of PsA among patients with psoriasis. The primary endpoint will be the proportion of patients diagnosed with PsA among patients with psoriasis referred to a rheumatologist. This will be evaluated in the following groups: 1) PEST-positive and dermatologist-negative patients 2) PEST-positive and dermatologist-positive patients 3) PEST-negative and dermatologist-positive patients 4) PEST-negative and dermatologist-negative patients The primary comparison of the proportions of patients diagnosed with PsA (Fisher's exact test) will be done between the dermatologist-negative vs. positive patients among PEST-positive ones (group 1 vs. group 2).

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis

The goal of this clinical trial is to study the drug LPX-TI641 in patients with atopic dermatitis and psoriasis. We will compare the safety and tolerability of LPX-TI641 to placebo ( a look-alike solution) that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.

A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults

This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 12. Secondary outcomes include change in body mass index (BMI) and safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups.

A Phase 2 Study of HB0017 in Psoriasis Patients

This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects