Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
RecruitingThe goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age. The main questions it aims to answer are: Does the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs? Researchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles. All participants will: * receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection; * undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses; * attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests; * report any symptoms or adverse events using a standardized diary for 42 days; * be followed for up to one year for long-term safety and immunogenicity assessments. * wear a device for 14 consecutive days to assess current and habitual physical activity levels. * answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status. * collect blood samples one-year after vaccination to access immunogenicity and cellular response. Researcher will also perform subgroups analysis in: A viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration. An immunogenicity subgroup (\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.
PhasePhase 4
TypeInterventional
Age12 Years – 59 Years
WhereSão Paulo, São Paulo, Brazil + 1 more
SponsorUniversity of Sao Paulo General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
RecruitingThis randomized controlled trial aims to compare the efficacy of methotrexate (MTX) monotherapy versus combined methotrexate and selective serotonin reuptake inhibitor (SSRI) therapy in patients with psoriasis and comorbid depression and/or anxiety. Participants will be randomly assigned to two groups: one receiving MTX alone and the other receiving MTX plus escitalopram. Clinical outcomes will be evaluated over a 6-month period, including psoriasis severity using the Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA), quality of life using the Dermatology Life Quality Index (DLQI), and psychological status using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A). The study will assess whether combination therapy provides superior clinical and psychological outcomes.
PhasePhase 4
TypeInterventional
Age18 Years – 60 Years
WhereCairo, Cairo Governorate, Egypt
SponsorCairo University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Swiss Dermatology Network of Targeted Therapies (SDNTT)
RecruitingThe purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy. The registry will also evaluate safety clinical outcomes and health related quality of life.
Phase—
TypeObservational
Age18 Years
WhereAarau, Switzerland + 5 more
SponsorSwiss Dermatology Network for Targeted Therapies
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of Stigma Toward Patients With Alopecia Areata, Atopic Dermatitis, Vitiligo, and Psoriasis
NCT06801821 ·
Psoriasis (PsO), Vitiligo Vulgaris, Atopic Dermatitis
RecruitingPrimary objective: The primary objective is to evaluate in the general population the difference between emotional reactions associated with facial involvement by four major dermatologic diseases: psoriasis, atopic dermatitis, vitiligo, and alopecia areata. * Compare the social distance and stereotyping by the general population toward individuals with facial involvement by: psoriasis, atopic dermatitis, vitiligo, and alopecia areata. * Evaluate demographic factors that describe a greater tendency toward stigmatization.
Phase—
TypeObservational
Age18 Years
WhereRoma, Italia, Italy
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)
RecruitingIt is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)
Phase—
TypeObservational
Age18 Years
WhereNanjing, Jiangsu, China + 1 more
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
▾Tap for detailsClick for full details — eligibility, all locations, contacts Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults
NCT07000916 · Juvenile Idiopathic Arthritis,
Rheumatoid Arthritis, Psoriatic Arthritis
RecruitingPopulation: Juvenile idiopathic arthritis (JIA), rheumatoid arthritis (RA) and seronegative / psoriatic / undifferentiated arthritis (UA), systemic lupus erythematosus (SLE) or diffuse systemic sclerosis dSS). Naïve to basic treatment OR treated for ≤ 3 months; except for patients with JIA. These 5 cohorts will be subject to standardized clinical monitoring.
Phase—
TypeObservational
Age2 Years – 50 Years
WhereBrussels, Belgium
SponsorUniversité Catholique de Louvain
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereHefei, Anhui, China + 45 more
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)
NCT07611747 ·
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Axial Spondy
RecruitingPREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment. Patients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.
PhasePhase 4
TypeInterventional
Age50 Years
WhereAlicante, Alicante, Spain + 16 more
SponsorInstituto de Investigación Marqués de Valdecilla
▾Tap for detailsClick for full details — eligibility, all locations, contacts HIPPOCRATES Prospective Observational Study
NCT05858528 · Psoriatic Arthritis,
Psoriasis RecruitingHIPPOCRATES 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 will run across Europe. The study will be led by a research team at University of Oxford and supported by a team at University College Dublin. We are aiming 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. We 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. We are recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires will include a 'screening questionnaire' to try to identify arthritis. If participants are identified by the 'screening questionnaire' as having possible arthritis, they will be advised to seek local medical help. We will follow up with them to see if they are diagnosed with psoriatic arthritis. Alongside the questionnaire information from participants, we will ask some participants to provide a blood fingerprick sample using an easy to use at home sampling kit. The blood sample will be posted to a central location (University College Dublin) where it will be stored and then studied in the laboratory to look for markers that may predict the onset of arthritis. As many (most) participants will not develop arthritis, we are also studying the impact of psoriasis on the participants to learn more about how psoriasis affects people's daily lives across Europe.
Phase—
TypeObservational
Age18 Years
WhereOxford, Oxfordshire, United Kingdom
SponsorUniversity of Oxford
▾Tap for detailsClick for full details — eligibility, all locations, contacts AYLo - AutoimmunitY and Loss of y
NCT06696027 · Giant Cell Arteritis (GCA), Polymyalgia Rheumatica (PMR), ANCA Associated Vasculitis (AAV)
RecruitingThe AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies. Through the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation. A further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data. Additionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders. By integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.
Phase—
TypeObservational
Age50 Years
WhereBonn, North Rhine-Westphalia, Germany
SponsorUniversity of Bonn
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
NCT07321873 · Arthritis, Psoriatic
RecruitingThe purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSearcy, Arkansas, United States + 67 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)
RecruitingThe purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis
Phase—
TypeObservational
Age18 Years
WhereAmiens, France + 47 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
RecruitingThe purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
PhasePhase 3
TypeInterventional
Age12 Years – 17 Years
WhereBirmingham, Alabama, United States + 122 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
RecruitingThe study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .
PhasePhase 1
TypeInterventional
Age18 Years – 65 Years
WhereAnaheim, California, United States + 8 more
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
NCT07183423 ·
Psoriasis, Atopic Dermatitis, Xerosis
RecruitingThe goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. The main questions it aims to answer are: Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction. Participants will: Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product
PhaseNA
TypeInterventional
Age18 Years
WhereMakati City, National Capital Region, Philippines
SponsorMakati Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
RecruitingA single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
PhaseNA
TypeInterventional
Age18 Years
WhereEast Windsor, New Jersey, United States
SponsorPsoriasis Treatment Center of Central New Jersey
▾Tap for detailsClick for full details — eligibility, all locations, contacts Creating Health Course Study for People With Rheumatological Conditions
RecruitingThe goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
PhaseNA
TypeInterventional
Age18 Years – 100 Years
WhereIowa City, Iowa, United States
SponsorTerry L. Wahls
▾Tap for detailsClick for full details — eligibility, all locations, contacts CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
RecruitingProspective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target
Phase—
TypeObservational
Age18 Years
WhereWaltham, Massachusetts, United States
SponsorCorEvitas
▾Tap for detailsClick for full details — eligibility, all locations, contacts Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
NCT07286058 · Psoriatic Arthritis
RecruitingPsoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time. Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD). Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.
PhasePhase 3
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States
SponsorTakeda
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms
NCT06786936 · Psoriatic Arthritis,
Depression, Psoriatic Plaque
RecruitingThe investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease. Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms. The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism. Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.
Phase—
TypeObservational
Age18 Years – 74 Years
WhereGlasgow, Scotland, United Kingdom
SponsorNHS Greater Glasgow and Clyde
▾Tap for detailsClick for full details — eligibility, all locations, contacts