Psoriasis – Trials in Disease

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Clinical Trials for Psoriasis: Current Research and Treatment Studies

This article presents an overview of 46 ongoing clinical trials investigating new treatments for psoriasis, a chronic skin condition causing red, scaly patches. Research is underway across multiple European countries testing various medications including oral tablets, injections, and topical treatments for plaque psoriasis, psoriatic arthritis, and related conditions. These studies focus on evaluating the effectiveness, safety, and long-term outcomes of emerging therapies for patients with moderate to severe symptoms.

Clinical trial locations

Comparison of zasocitinib and deucravacitinib in adults with moderate to severe plaque psoriasis

This trial compares two oral medications for treating moderate to severe plaque psoriasis in adults. The study involves participants who have had this skin condition for at least 6 months.

Main inclusion criteria: Participants must be at least 18 years old and have plaque psoriasis affecting at least 10% of their body surface area. They need specific severity scores (PASI score of 12 or higher and sPGA score of 3 or higher) and must be suitable for either light therapy or whole-body medication treatment.

Main exclusion criteria: The study excludes people under 18 or over 65 years, pregnant or breastfeeding women, those with active infections including tuberculosis, significant heart or kidney/liver disease, current or recent cancer, active substance abuse, recent participation in other trials, use of other psoriasis treatments within specific timeframes, severe uncontrolled high blood pressure, unstable mental health conditions, and certain autoimmune conditions other than psoriasis.

Study focus: The trial evaluates whether zasocitinib works better than deucravacitinib in improving skin condition over 16 weeks. Both medications are taken once daily as tablets. The effectiveness is measured by examining improvements in affected skin areas and the severity of symptoms. Regular check-ups monitor participants’ health and safety throughout the study.

Investigational drugs: Zasocitinib (TAK-279) is a once-daily oral medication that modifies immune system response. Deucravacitinib is an oral medication that targets specific proteins in the immune system responsible for inflammation. It is already approved for treating moderate to severe plaque psoriasis in some countries and serves as a comparison treatment in this study.

Study on Bimekizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

This clinical trial studies two injectable treatments for moderate to severe plaque psoriasis in children and teenagers aged 6 to under 18 years.

Main inclusion criteria: Participants must be between 6 and 17 years old, weigh more than 15 kg, have a body mass index at or above the 5th percentile for their age, and have been diagnosed with moderate to severe plaque psoriasis for at least 3 months. They need specific severity measurements (PASI score of 12 or more, IGA score of 3 or more, and body surface area affected by psoriasis of 10% or more). Participants must be suitable for systemic therapy and/or light therapy or chemotherapy, as well as treatment with ustekinumab. Appropriate vaccinations for age are required.

Main exclusion criteria: The study excludes patients with other serious health conditions that could interfere, those currently in another trial, recent infections requiring antibiotics, history of allergic reactions to similar medications, pregnant or breastfeeding participants, recent vaccine recipients, history of drug or alcohol abuse, certain blood disorders, weakened immune system, recent surgery, certain skin conditions other than psoriasis, history of cancer, liver or kidney problems, uncontrolled high blood pressure, and heart problems.

Study focus: The trial compares bimekizumab and ustekinumab effectiveness and safety. Both medications are given as injections under the skin. During the initial treatment period, researchers assess improvement in skin condition using PASI and IGA measurements at Week 16. The maintenance period continues treatment to maintain improvements, with monitoring at Week 48. Throughout the study, regular assessments monitor health, treatment impact, and quality of life changes, including growth and development monitoring.

Investigational drugs: Bimekizumab is administered through subcutaneous injection and works by inhibiting interleukin-17A and interleukin-17F to decrease inflammation and plaque formation. Ustekinumab is also administered via subcutaneous injection and targets interleukin-12 and interleukin-23, helping reduce the immune response that leads to psoriasis symptoms.

Study on Deucravacitinib for Children with Moderate to Severe Plaque Psoriasis

This trial studies deucravacitinib for treating moderate to severe plaque psoriasis in children and teenagers aged 4 to 18 years. The medication comes as film-coated tablets or granules in a sachet.

Main inclusion criteria: Participants must be between 12 and under 18 years for Cohort 1, or 4 to under 12 years for Cohort 2. They need a diagnosis of stable moderate to severe plaque psoriasis (no major changes for the past 6 months) with specific measurements: PASI score of 12 or higher, sPGA score of 3 or higher, and Body Surface Area with 10% or more affected. Participants should be candidates for light treatment or medication affecting the whole body. Written permission from parents or guardians is required, and participants must complete the Week 52 treatment period in Part A or B of the study.

Main exclusion criteria: The study excludes patients without moderate to severe plaque psoriasis, those outside the age range of 4 to 18 years, those unwilling to follow study procedures, those with other significant health issues, pregnant or breastfeeding individuals, recent participants in another clinical trial, those allergic to the study medication or its ingredients, and those taking certain medications that might interfere.

Study focus: The study evaluates how the body processes the medication, its effectiveness in improving skin condition, and its safety for long-term use. Participants are divided into age groups and receive medication through oral administration. The study continues with a maintenance dosage following the adjustment phase, with regular assessments including skin examinations and PASI score measurements. There is an optional long-term extension period for additional safety and tolerability evaluation, with monitoring of growth including body weight, height, and sexual maturation.

Investigational drugs: Deucravacitinib is administered orally in tablet form and targets specific proteins in the immune system to reduce inflammation and slow down the overproduction of skin cells. It belongs to a class of drugs known as selective tyrosine kinase 2 (TYK2) inhibitors, which help modulate immune responses.

Study on How Bimekizumab Affects People with Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

This trial studies how bimekizumab affects biological markers in people with moderate to severe plaque psoriasis and psoriatic arthritis. The medication is given as an injection under the skin using a prefilled pen.

Main inclusion criteria: Participants must be at least 18 years old with a diagnosis of plaque psoriasis for at least 6 months. Some participants must also have psoriatic arthritis for at least 6 months with at least 1 tender joint and 1 swollen joint. Specific measurements are required: PASI score of 12 or higher, at least 10% of body surface area affected by psoriasis, and IGA score of 3 or higher. Participants must be candidates for systemic psoriasis therapy and/or light therapy, agree not to change usual sun exposure during the study, weigh less than 120 kg, and female participants must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.

Main exclusion criteria: The study excludes patients with other serious health conditions, those with recent infections requiring treatment, recent live vaccine recipients, history of cancer (except certain skin cancers), pregnant or breastfeeding individuals, history of drug or alcohol abuse within the past year, recent participants in another clinical trial, known allergy to the study medication, and any condition making them unsuitable for the study.

Study focus: The trial monitors changes in gene expression biomarkers at Week 48. During the initial visit, eligibility is confirmed through medical history review and physical examination, with informed consent obtained. Baseline assessments include measuring psoriasis severity using PASI and IGA, and a skin biopsy may be taken. The treatment is administered through subcutaneous injection with dosage determined by the study protocol. Regular follow-up visits monitor health and treatment effects, including physical examinations and psoriasis assessments. The Week 48 assessment includes a comprehensive evaluation with another skin biopsy to compare changes in gene expression. A safety follow-up phase monitors any treatment-emergent adverse events.

Investigational drugs: Bimekizumab works by targeting specific proteins in the immune system that are involved in inflammation, helping to reduce symptoms like skin plaques and joint pain. It is classified as a monoclonal antibody designed to interact with the immune system to treat autoimmune conditions.

Study on Long-term Safety and Effectiveness of ESK-001 for Patients with Moderate to Severe Plaque Psoriasis

This extension trial evaluates the long-term safety and effectiveness of ESK-001 for moderate to severe plaque psoriasis. The medication is taken as tablets by mouth.

Main inclusion criteria: Participants must be 18 years or older and have completed one of two previous ESK-001 studies for moderate to severe plaque psoriasis. The safety and tolerability of ESK-001 must have been acceptable in the previous study. Women of childbearing potential and sexually active males must agree to use highly effective contraception methods throughout the study.

Main exclusion criteria: The study excludes patients with other skin conditions that might interfere, those with recent or current infections, history of severe allergic reactions, current use of other psoriasis treatments that might interfere, certain heart conditions, uncontrolled high blood pressure, liver or kidney problems, pregnant or breastfeeding individuals, recent participants in another trial, and history of drug or alcohol abuse.

Study focus: Upon joining, participants are confirmed to have completed a previous study with acceptable safety results. They receive ESK-001 as film-coated tablets taken orally, with the maximum treatment duration being 24 weeks. Throughout the study, regular monitoring and assessments evaluate treatment safety and effectiveness through physical examinations, blood tests, and health/quality of life questionnaires. Participants are asked to report any side effects or adverse reactions. At the end of the study period, a final assessment determines overall treatment outcomes.

Investigational drugs: ESK-001 targets specific molecules contributing to inflammation and rapid skin cell growth in psoriasis. It is classified as a treatment for skin disorders, designed to help manage symptoms and improve quality of life.

Study on Long-term Safety and Effectiveness of Zasocitinib for Patients with Moderate-to-Severe Plaque Psoriasis

This extension study evaluates the long-term safety and effectiveness of zasocitinib (TAK-279) for moderate to severe plaque psoriasis. The medication is taken as film-coated tablets once daily by mouth.

Main inclusion criteria: Participants must be willing and able to understand and follow all study procedures, including using digital tools and applications. They must provide written informed consent and be 18 years or older (with safety assessment for those 65 or older in EU/EEA and UK). Participants need a diagnosis of chronic plaque psoriasis for at least 6 months before screening, with stable condition (no significant changes for at least 6 months). Specific measurements are required: PASI score of 12 or more, sPGA score of 3 or more, and plaque psoriasis covering at least 10% of total body surface area. Participants must be candidates for light treatment or whole-body medication treatment. Those capable of becoming pregnant must meet certain birth control requirements. Participants must have completed 52 weeks of treatment in a previous related study or 60 weeks in another. Participation must not pose undue risk or interfere with study results. In EU/EEA or UK, investigators must ensure participation doesn’t pose risk based on JAK inhibitor guidelines. For current or former long-term tobacco users, investigators must determine benefits outweigh risks.

Main exclusion criteria: The study excludes patients without moderate to severe plaque psoriasis, those outside the specified age range, and those who are part of a vulnerable population (unable to give consent or in a dependent relationship with study staff).

Study focus: The initial assessment confirms eligibility including moderate to severe plaque psoriasis and candidacy for light therapy or whole-body medication treatment. Written informed consent is required before any study procedures, with agreement to comply with study procedures including digital tool use if necessary. The medication TAK-279 is administered orally once daily in film-coated tablet form. Ongoing monitoring tracks treatment-emergent adverse events and serious adverse events, with regular assessments evaluating psoriasis symptom improvement using PASI and sPGA measurements. The study evaluates long-term safety and efficacy, with potential participation lasting until the estimated end date in May 2026 for those who completed previous related studies.

Investigational drugs: TAK-279 is an oral medication taken once daily, currently in Phase 3 clinical trial for long-term safety, tolerability, and efficacy in moderate to severe plaque psoriasis. It targets specific pathways in the immune system to reduce inflammation and slow skin cell overproduction, classified as an immunomodulatory agent.

Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis

This extension trial evaluates the long-term safety of secukinumab for patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis. The medication is administered as injections under the skin.

Main inclusion criteria: Participants must provide signed informed consent (with written informed assent and parental permission for children, and signing corresponding informed consent upon reaching age of consent). They must communicate effectively with the study team and be willing to follow requirements. Participants must have completed treatment in a previous Novartis study involving secukinumab unless specified otherwise. If the previous study was stopped for reasons not related to safety or effectiveness, participants may still be eligible. Participants must benefit from secukinumab treatment, with the study doctor believing continuing treatment is more beneficial than risky. Participants must not have access to marketed secukinumab through local prescription or reimbursement guidelines.

Main exclusion criteria: The study excludes patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis.

Study focus: Upon joining, participants must provide signed informed consent (or written informed assent and parental permission if minor, with signing corresponding study informed consent upon reaching age of consent). An initial assessment confirms participants completed a previous Novartis study of secukinumab and are benefiting from treatment, with the investigator evaluating if continuing treatment is beneficial and benefits outweigh risks. Treatment is administered through subcutaneous injection with dosage, frequency, and duration determined by study protocol and investigator judgment, aiming to manage various inflammatory conditions. Ongoing monitoring tracks adverse events and serious adverse events including injection site reactions, with regular check-ups assessing treatment response. The study concludes by January 5, 2027, with final assessment evaluating long-term safety and effectiveness.

Investigational drugs: Secukinumab targets specific proteins in the immune system to reduce inflammation and improve symptoms. It is classified as a biologic drug, specifically a monoclonal antibody.

Study on Risankizumab for Children Aged 6-17 With Moderate to Severe Plaque Psoriasis After Completing Previous Study

This extension study evaluates the long-term safety, tolerability, and effectiveness of risankizumab in participants who completed the previous study (M19-977). The medication is given as injections under the skin using a pre-filled syringe.

Main inclusion criteria: Participants must have completed participation in Study M19-977 and meet all eligibility criteria for Study M19-973. The study is open to any gender and adults 18 years or older. Individuals considered part of a vulnerable population (groups needing special protection or care) can participate.

Main exclusion criteria: The study excludes patients who haven’t completed the previous study (M19-977), those with medical conditions other than plaque psoriasis, those outside the specified age range, and those who are part of a vulnerable population.

Study focus: The study monitors participants who previously used risankizumab to assess long-term effects. During enrollment, participation in the previous study is confirmed and eligibility criteria verified. An initial health assessment establishes a baseline for the study through physical examinations and health/symptom questionnaires. The medication is administered as subcutaneous injection using a pre-filled syringe, with frequency and dosage determined by study protocol. Regular follow-up visits monitor health, assess medication effects, and ensure safety through physical examinations and health/symptom questions. Participants report any adverse events or side effects experienced during the study. At the study’s end, a final health assessment determines long-term medication effects and overall health status.

Investigational drugs: Risankizumab targets the interleukin-23 (IL-23) protein, reducing inflammation and alleviating psoriasis symptoms. It is classified as a monoclonal antibody designed to target specific proteins in the body.

Study on the Effects and Safety of Piclidenoson for Patients with Moderate-to-Severe Plaque Psoriasis

This trial evaluates the effectiveness and safety of piclidenoson for moderate to severe plaque psoriasis. The medication is taken as tablets by mouth twice daily.

Main inclusion criteria: Participants must be males and females aged 18 years or older, able to complete the study following the plan, understand and sign written consent, have a diagnosis of moderate to severe chronic plaque-type psoriasis with at least 10% body surface area affected, PASI score of 12 or higher at initial visits, Static PGA score of 3 or higher at initial visits, be candidates for systemic treatment or light therapy, have had psoriasis for at least 12 months, females who can become pregnant must have negative pregnancy test at study start, use at least one acceptable birth control method during the study and for 1 month after last dose, and male participants must not donate sperm during the study and for at least 1 month after last dose and agree to use condoms during the study and for 1 month after.

Main exclusion criteria: The study excludes patients with other skin conditions interfering with plaque psoriasis evaluation, those using other plaque psoriasis treatments within certain periods before study start, history of severe allergic reactions to study medication ingredients, significant medical conditions interfering with study results or posing patient risk, pregnant or breastfeeding individuals, current participants in another clinical trial, history of drug or alcohol abuse, recent major surgery, certain uncontrolled infections, and history of certain cancer types.

Study focus: Upon joining, participants are randomly assigned to receive either piclidenoson, a placebo, or an active comparator. The study is double-blind, with neither participants nor study team knowing which treatment is received. Participants take the assigned tablet orally twice daily (3 mg per tablet if receiving piclidenoson) for the study duration planned until January 31, 2028. Throughout the study, regular visits with the study team monitor health and treatment effects, with assessments including psoriasis evaluations using PASI and sPGA measurements. At week 16, a key evaluation determines treatment effectiveness by assessing if participants achieve PASI 75 response (75% improvement) and sPGA score of 0 or 1 (clear or almost clear skin). Safety monitoring is prioritized throughout, with participants asked to report any health changes or concerns during the trial. Upon study completion, participants have a final visit assessing overall health and treatment outcomes, with the study team providing information on next steps and any necessary follow-up care.

Investigational drugs: Piclidenoson targets specific receptors in the body to reduce inflammation and slow rapid skin cell growth. It is classified as an anti-inflammatory agent.

Study on the Effects of IDP-118 Lotion (Tazarotene and Halobetasol Propionate) for Children with Moderate to Severe Plaque Psoriasis

This trial evaluates the safety and absorption of IDP-118 lotion (Duobrii) containing tazarotene and halobetasol propionate when used by children and teenagers with moderate to severe plaque psoriasis. The lotion is applied to the skin once daily for up to eight weeks.

Main inclusion criteria: Participants must be males or females of any race, aged between 12 to 16 years and 11 months at consent, willing to follow study instructions and attend required clinic visits, have given verbal and written permission with parent or legal guardian if needed, have confirmed psoriasis diagnosis with specific severity score of 3 or 4 (excluding face, scalp, armpits, and skin folds), have plaque psoriasis covering at least 10% of body (excluding face, scalp, armpits, and skin folds), be willing to avoid long sun exposure or artificial UV light on treatment area, have healthy adrenal glands checked by cortisol test, be in good general health based on medical history and physical exam with normal or not concerning blood test results, and females who have started menstruating or can become pregnant must have negative pregnancy test before study and agree to use effective birth control during the study (if using birth control pills, must have been on same type for at least three months before study and not change during study; if stopped using birth control pills, must have been at least three months before study).

Main exclusion criteria: The study excludes pregnant or breastfeeding patients, individuals with allergic reaction history to study lotion ingredients, those currently using other plaque psoriasis treatments who must stop before joining, people with certain interfering skin conditions, individuals with weakened immune systems, patients with certain serious medical condition history (heart disease or uncontrolled diabetes), recent participants in another clinical trial (within last 30 days), those unable to follow study instructions or attend required visits.

Study focus: During the initial visit, study team confirms eligibility based on age, health status, and moderate to severe plaque psoriasis presence. Physical examination is conducted, medical history reviewed, and blood test performed to check adrenal health and ensure normal cortisol levels. A baseline assessment evaluates psoriasis severity using IGA score and measures affected body surface area (BSA) excluding face, scalp, axillae, and intertriginous areas. The treatment involves applying Duobrii lotion (containing tazarotene and halobetasol propionate) topically once daily for total duration of 8 weeks, with first 4 weeks focusing on monitoring systemic exposure to active ingredients. Regular follow-up visits monitor progress and potential side effects, with study team assessing treatment safety and checking for HPA axis suppression signs. At 8-week treatment period end, final assessment evaluates overall treatment effectiveness and psoriasis severity changes.

Investigational drugs: IDP-118 Lotion combines HP (halobetasol propionate) and Taz (tazarotene), working by reducing inflammation and slowing skin cell growth. It is classified as combination of corticosteroid and retinoid.

Summary

The 46 clinical trials presented demonstrate significant global research activity focused on developing new treatments for psoriasis, with Poland, Germany, and Spain emerging as major research hubs. Multiple trials concentrate on oral medications including zasocitinib, deucravacitinib, and various experimental compounds, reflecting a trend toward convenient once-daily tablet formulations. Several studies specifically target pediatric populations (ages 4-18), addressing the important need for safe and effective treatments for younger patients. Injectable biologics such as bimekizumab, risankizumab, guselkumab, and secukinumab continue to be extensively studied, with many trials examining long-term safety and effectiveness. The research landscape includes direct comparison studies between different medications, extension studies for long-term safety monitoring, and investigations into difficult-to-treat areas such as scalp, genital, and nail psoriasis. Notable focus areas include immune system mechanisms, with several trials examining how treatments affect specific immune cells and inflammatory pathways.

Ongoing Clinical Trials on Psoriasis

  • Study on the Effectiveness and Safety of ESK-001 and Apremilast for Patients with Moderate to Severe Plaque Psoriasis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Estonia France Germany Hungary Latvia +3
  • Study on the Effectiveness of LY4100511 for Adults with Moderate-to-Severe Plaque Psoriasis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Poland
  • Study on Guselkumab for Patients with Moderate-to-Severe Plaque Psoriasis

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Germany
  • Study on Guselkumab and Etanercept for Treating Chronic Plaque Psoriasis in Children Aged 6 to 17 Years

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Hungary Italy Poland
  • Study on the Effectiveness and Safety of HRO350 for Patients with Mild-to-Moderate Psoriasis

    Not recruiting

    2 1 1
    Investigated diseases:
    Finland Germany Norway Poland
  • Study of Risankizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland Spain
  • Study on the Effectiveness and Safety of DC-806 for Adults with Moderate to Severe Plaque Psoriasis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Poland Spain