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Clinical Trials for Psoriatic Arthropathy (Psoriatic Arthritis)

There are currently 37 ongoing clinical trials investigating various treatments for psoriatic arthropathy, also known as psoriatic arthritis. These trials are testing both new medications and existing treatments to improve joint symptoms, reduce inflammation, and enhance quality of life for patients. Studies are being conducted across multiple European countries including Germany, Poland, Spain, Italy, France, and many others. The trials evaluate different types of medications including biological drugs, targeted therapies, and vaccines, with most studies comparing new treatments to placebo or existing medications.

Clinical trial locations

Study of Ixekizumab Treatment Effects on Joint and Bone Inflammation in Patients with Axial Spondyloarthritis and Psoriatic Arthritis Using Advanced Imaging Methods

This Danish study is testing ixekizumab (Taltz) in patients with both axial spondyloarthritis and psoriatic arthritis. The trial uses advanced imaging techniques including whole-body MRI and CT scans to monitor how the medication affects inflammation throughout the body over a two-year period.

Main inclusion criteria: Participants must be at least 18 years old and have received a doctor’s recommendation for biological drug treatment. For those with psoriatic arthritis specifically, they must meet CASPAR diagnostic criteria, test negative for rheumatoid factor and anti-CCP antibodies, have at least one tender and swollen joint plus two other areas showing inflammation, and show evidence of spine involvement on imaging if the spine is affected.

Main exclusion criteria: The trial excludes patients with a history of severe allergic reactions to biological medications, active or untreated tuberculosis, serious infections requiring hospitalization within the past three months, other active autoimmune diseases, recent cancer (within five years), significant uncontrolled heart, liver or kidney disease, demyelinating conditions like multiple sclerosis, pregnancy or breastfeeding, inability to undergo MRI scanning, current participation in other trials, and recent substance abuse.

Focus and goals: The study aims to examine how ixekizumab affects inflammation in joints, the spine, and attachment points of tendons and ligaments to bones. Researchers will track changes through regular MRI scans and assessments throughout the two-year treatment period, monitoring both spine-related symptoms and joint inflammation.

Investigational drug: Ixekizumab is administered as a subcutaneous injection at doses up to 160 mg per day. It works by targeting and blocking interleukin-17A, a protein that causes inflammation, thereby helping to reduce joint pain, stiffness and swelling in affected areas.

Study of Risankizumab vs. Placebo for Patients with Active Psoriatic Arthritis Who Have Not Responded Well to Previous Biologic Treatments

This multi-country trial is comparing risankizumab (also known as ABBV-066) to placebo in patients with active psoriatic arthritis who have not responded well to previous biological treatments. The study aims to evaluate whether risankizumab can reduce symptoms by week 24.

Main inclusion criteria: Participants must have a clinical diagnosis of psoriatic arthritis with symptoms present for at least six months before screening. They must have active disease at baseline, confirmed by active plaque psoriasis with at least one lesion 2 centimeters or larger or nail changes consistent with psoriasis. Patients must have a history of inadequate response or intolerance to previous biological or conventional synthetic DMARD therapies.

Main exclusion criteria: Specific exclusion criteria were not detailed beyond general restrictions based on disease type, age range, and vulnerable population status.

Focus and goals: The primary goal is to assess how many participants achieve an ACR20 response (20% improvement in symptoms) by week 24. Secondary assessments include changes in health questionnaires, ACR50 and ACR70 responses, and resolution of specific symptoms like enthesitis (inflammation where tendons attach to bone) and dactylitis (swollen fingers or toes).

Investigational drug: Risankizumab is given as a 150 mg subcutaneous injection. It works by targeting and inhibiting interleukin-23, a protein involved in inflammation, helping to reduce pain and swelling associated with psoriatic arthritis.

Study of sonelokimab and risankizumab in adults with psoriatic arthritis who did not respond well to previous TNF inhibitor treatment

This European trial is testing sonelokimab against risankizumab in patients who have not responded adequately to TNF inhibitor treatment. The study evaluates two different doses of sonelokimab (60 mg and 120 mg) compared to risankizumab.

Main inclusion criteria: Participants must be at least 18 years old with psoriatic arthritis diagnosed for six months or longer. They must have moderate to severe active disease with at least three tender and swollen joints, active plaque psoriasis or nail changes, and previous treatment with one or two TNF inhibitors that either didn’t work well or caused side effects.

Main exclusion criteria: Exclusions include age restrictions (below 18 or above 65), previous sonelokimab treatment, active or chronic infections including tuberculosis or hepatitis, recent cancer (within five years), pregnancy or breastfeeding, significant heart, liver or kidney disease, current biological medication use, planned major surgery during the study, recent participation in another trial, uncontrolled high blood pressure, active skin conditions other than psoriasis, recent substance abuse, mental health conditions affecting participation, known allergies to study components, and recent live vaccine administration.

Focus and goals: The main goal is to achieve at least 50% improvement in arthritis symptoms (ACR50) after 16 weeks of treatment. The study also monitors safety through regular check-ups including blood pressure, heart rate, blood tests, body weight, ECG monitoring, and tracking of side effects.

Investigational drugs: Sonelokimab is given as subcutaneous injections in either 60 mg or 120 mg doses. It is a novel biological medication that modulates specific immune system components involved in inflammation. Risankizumab serves as the active comparator and is already approved for psoriatic arthritis, working by blocking interleukin-23 to reduce inflammation.

Study of sonelokimab injection in adults with active psoriatic arthritis who have not received biological DMARDs treatment before

This large multi-country trial is testing sonelokimab in patients who have never received biological DMARD treatment. The study compares two different dosing regimens of sonelokimab (with and without an initial induction period) against placebo.

Main inclusion criteria: Participants must be at least 18 years old with psoriatic arthritis for at least six months, having at least three tender and swollen joints. They must have at least one psoriatic plaque of 2 cm or more or nail changes consistent with psoriasis. Patients must test negative for rheumatoid factor and anti-cyclic citrullinated peptide. They should have tried conventional DMARD therapy for at least 12 weeks with inadequate response or documented inability to take these medications, and must have at least one bone erosion on X-rays or elevated C-reactive protein levels.

Main exclusion criteria: Exclusions include age restrictions (below 18 or above 75), previous sonelokimab treatment, known allergies to biological medications, active or chronic infections including tuberculosis and hepatitis, recent cancer (within five years except successfully treated non-melanoma skin cancer), pregnant or breastfeeding women, significant heart problems or uncontrolled high blood pressure, severe kidney or liver disease, other inflammatory arthritis conditions, planned major surgery, recent participation in other trials, active substance abuse or mental health conditions, use of prohibited immunosuppressive medications, unstable disease requiring immediate treatment change, and recent live vaccine administration.

Focus and goals: The primary goal is to achieve 50% improvement in arthritis symptoms (ACR50) at week 16. The study monitors joint symptoms, psoriasis improvement, overall health status, and quality of life through regular assessments including X-rays to check joint damage.

Investigational drug: Sonelokimab is administered as a 60 mg subcutaneous injection every four weeks. It is a novel biological medication currently in Phase 3 trials that targets specific inflammatory pathways involved in psoriatic arthritis.

Study of Zasocitinib and Apremilast for Adults with Active Psoriatic Arthritis Who Have Not Used Biologic Medicines

This European trial is comparing zasocitinib (TAK-279) at two different doses against placebo and apremilast in patients who have not previously used biological medicines. The study aims to determine the optimal treatment approach for this patient population.

Main inclusion criteria: Participants must be 18 years or older with signs and symptoms of psoriatic arthritis for at least three months. They must meet CASPAR criteria and have active arthritis with at least three tender and swollen joints. Patients must have at least one active plaque psoriasis lesion 2 cm or larger or nail changes characteristic of psoriasis. They should have had inadequate response to NSAIDs after at least four weeks or to conventional synthetic DMARDs after at least 12 weeks, or intolerance to these medications. If taking conventional DMARDs at baseline, patients must be on stable doses for specific periods with dose limitations for each medication.

Main exclusion criteria: Exclusions were not fully specified but include patients without active psoriatic arthritis, those outside the specified age range, and vulnerable populations.

Focus and goals: The study evaluates whether zasocitinib can improve arthritis symptoms and quality of life over 52 weeks. Regular check-ups monitor health and symptom changes, with assessments of joint symptoms and overall disease activity.

Investigational drug: Zasocitinib is taken orally as film-coated tablets at either Dose A or Dose B. It works by inhibiting specific enzymes (Janus kinases) that contribute to inflammation, helping to reduce joint pain and swelling.

Study on Deucravacitinib for Patients with Active Psoriatic Arthritis New to Biologic Treatments

This multi-country trial is testing deucravacitinib in patients who have not previously been treated with biological disease-modifying anti-rheumatic drugs. The study compares deucravacitinib to placebo over 16 weeks.

Main inclusion criteria: Participants must have been diagnosed with psoriatic arthritis for at least three months before screening and meet CASPAR classification criteria. They must have active plaque psoriasis with at least one lesion 2 cm or larger or a documented history of plaque psoriasis. Active arthritis is confirmed by at least three swollen and three tender joints at both screening and baseline, along with high-sensitivity C-reactive protein levels of 3 mg/L or higher and at least one joint erosion on X-rays.

Main exclusion criteria: Exclusions include other active autoimmune diseases, serious infections, recent cancer (within five years), liver or kidney disease, recent heart attack or stroke, pregnancy or breastfeeding, drug or alcohol abuse, recent live vaccines, and participation in other trials.

Focus and goals: The primary endpoint is the proportion of participants achieving a 20% improvement in symptoms (ACR20) at week 16. The study also evaluates changes in disease activity scores, physical function, and quality of life measures.

Investigational drug: Deucravacitinib is administered orally as 6 mg film-coated tablets once daily. It works by selectively inhibiting the enzyme TYK2, which plays a role in the inflammatory process associated with psoriatic arthritis.

Study on Guselkumab for Treating Psoriatic Arthritis in Patients New to Biologic Therapy

This large European trial is evaluating guselkumab in patients with psoriatic arthritis affecting the spine who have not previously received biological therapy. The study focuses on reducing axial symptoms.

Main inclusion criteria: Participants must be between 18 and 64 years old with a diagnosis of psoriatic arthritis meeting CASPAR criteria. They must have evidence of axial involvement shown by previous imaging, active inflammation in the spine or sacroiliac joints on MRI, chronic back pain for at least three months, active disease with specific pain and inflammation scores, and have tried at least two different NSAIDs without adequate relief or have a contraindication to NSAIDs.

Main exclusion criteria: Specific exclusions were not detailed comprehensively but include patients without psoriatic arthritis or axial spondyloarthritis, those outside the age range, and those not meeting specified clinical criteria.

Focus and goals: The primary endpoint is the change in BASDAI score (a measure of disease activity) from baseline to week 24. The study evaluates reduction in axial symptoms, including spinal pain and inflammation.

Investigational drug: Guselkumab is administered as a 100 mg/mL subcutaneous injection. It is a monoclonal antibody that works by targeting and inhibiting interleukin-23, a protein involved in inflammatory processes.

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

This German and Polish study is investigating how bimekizumab affects gene expression biomarkers in patients with both moderate to severe plaque psoriasis and psoriatic arthritis. The trial uses skin biopsies to analyze treatment effects at the molecular level.

Main inclusion criteria: Participants must be at least 18 years old with a diagnosis of plaque psoriasis for at least six months. They must have a PASI score of 12 or higher, at least 10% body surface area affected, and an IGA score of 3 or higher. For those with psoriatic arthritis, they must have at least one tender and one swollen joint documented within three months before screening. Patients must be candidates for systemic therapy or phototherapy and weigh less than 120 kg.

Main exclusion criteria: Exclusions include other serious health conditions, recent infections requiring treatment, live vaccines within four weeks, recent cancer (except certain skin cancers), pregnancy or breastfeeding, recent drug or alcohol abuse, participation in other trials within 30 days, known allergies to the medication, and any condition making participation unsuitable.

Focus and goals: The study evaluates changes in gene expression biomarkers at week 48, comparing findings to baseline measurements through skin biopsies. Safety monitoring includes tracking treatment-emergent adverse events throughout the study period.

Investigational drug: Bimekizumab is administered as subcutaneous injections using either pre-filled syringes or pre-filled pens. It is a monoclonal antibody that blocks two inflammatory proteins (IL-17A and IL-17F) involved in causing inflammation.

Study on Long-Term Safety and Efficacy of Tildrakizumab for Adults with Psoriatic Arthritis

This long-term safety study across multiple European countries is following patients who previously participated in tildrakizumab studies. The trial continues until December 2028 to assess long-term safety and effectiveness.

Main inclusion criteria: Participants must be adults who have completed a previous tildrakizumab study, completed its treatment period, and not have reasons that would have required early discontinuation. They must be able to understand study requirements, provide written consent, and follow study rules and attend scheduled treatments.

Main exclusion criteria: Specific exclusions include patients without psoriatic arthritis, those outside the adult age range, inability to understand or follow procedures, other interfering medical conditions, pregnancy or breastfeeding, recent participation in other trials, allergic reactions to similar medications, recent infections, and current use of certain prohibited medications.

Focus and goals: The study evaluates long-term safety and effectiveness through continued treatment over several years, monitoring serious adverse events, adverse events, and treatment responses using specific criteria.

Investigational drug: Tildrakizumab is given as subcutaneous injections from pre-filled syringes. It is a monoclonal antibody that targets interleukin-23, helping to reduce inflammation and symptoms associated with psoriatic arthritis.

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

This multi-country long-term safety study is following patients who have previously participated in secukinumab trials and are believed to benefit from continued treatment. The study runs until January 2027.

Main inclusion criteria: Participants must provide signed informed consent (or for minors, written informed assent with parental permission). They must be able to communicate effectively with the study team and be willing to follow study requirements. Participants must have completed a previous secukinumab study and be benefiting from treatment, with the investigator believing that continuing treatment will be more beneficial than risky. Patients must not have access to marketed secukinumab through local prescription or reimbursement.

Main exclusion criteria: The trial 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 who are participating in other studies.

Focus and goals: The study monitors long-term safety by tracking adverse events and serious adverse events over up to 104 weeks, including any reactions at injection sites. Regular check-ups assess response to treatment and ensure patient safety.

Investigational drug: Secukinumab is administered as 100 mg/mL subcutaneous injections. It is a biologic drug that works by targeting and blocking interleukin-17A, a protein involved in inflammation and immune response.

Study on Lutikizumab and Risankizumab for Adults with Active Psoriatic Arthritis

This trial in Poland, Hungary, Czechia and France is testing lutikizumab (ABT-981) both alone and in combination with risankizumab (ABBV-066) in patients with active psoriatic arthritis. The study evaluates whether combination therapy provides additional benefits.

Main inclusion criteria: Participants must have a documented clinical diagnosis of psoriatic arthritis with symptoms starting at least six months before screening. They must meet CASPAR classification criteria and have active disease with at least three tender and three swollen joints at screening and baseline. Patients must have active plaque psoriasis or documented history of plaque psoriasis.

Main exclusion criteria: Exclusions include other serious health conditions, recent infections requiring antibiotics or antivirals, live vaccines within four weeks, allergic reactions to similar medications, current participation in other trials, recent drug or alcohol abuse, pregnancy or breastfeeding, major surgery within 12 weeks, uncontrolled high blood pressure, and active cancer or recent cancer history (within five years except certain skin cancers).

Focus and goals: The primary goal is to achieve 50% improvement in symptoms (ACR50) by week 16. The study monitors changes in tender and swollen joints, skin symptoms, and overall disease activity.

Investigational drugs: Lutikizumab is given as subcutaneous injections targeting specific inflammatory proteins. Risankizumab is administered similarly and blocks interleukin-23 proteins that cause inflammation. Both medications aim to reduce pain and stiffness associated with psoriatic arthritis.

## Summary

The 37 ongoing clinical trials for psoriatic arthritis demonstrate a diverse and comprehensive research landscape across Europe. The trials are heavily concentrated in Central and Eastern European countries, with Poland, Germany, and Spain leading in trial participation, followed by Italy, Czechia, Hungary and Bulgaria. This geographic distribution suggests strong clinical research infrastructure in these regions.

A clear pattern emerges regarding medication types being tested. Biological therapies dominate the research pipeline, particularly monoclonal antibodies targeting specific inflammatory pathways. Several trials focus on interleukin inhibitors (IL-17, IL-23) including guselkumab, risankizumab, bimekizumab, tildrakizumab and ixekizumab. The new investigational agent sonelokimab appears in multiple trials at different dosing regimens. JAK inhibitors represent another significant focus, with studies examining tofacitinib, upadacitinib and zasocitinib in various patient populations.

The trials show thoughtful stratification by previous treatment history. Many studies specifically target either biological therapy-naive patients or those who have failed TNF inhibitor treatment, recognizing the need for different treatment approaches based on prior response patterns. Several long-term safety studies follow patients who completed earlier trials, demonstrating commitment to understanding medication effects over extended periods.

Notable specialized trials include studies using advanced imaging (whole-body MRI) to track treatment effects, research on optimal dosing times, vaccine response studies in patients on immunosuppressive therapy, and investigations of medication transfer into breast milk for nursing mothers. Several trials also examine combination therapies and treatment de-escalation strategies, representing important questions about optimizing long-term disease management.

Ongoing Clinical Trials on Psoriatic arthropathy

  • Study of Janus kinase inhibitor dose reduction in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis who have achieved low disease activity

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Ixekizumab for Patients with Refractory Psoriatic Arthritis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effectiveness and Safety of Zasocitinib (TAK-279) for Patients with Active Psoriatic Arthritis with Previous Biologic Treatment

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland Spain

  • Study of sonelokimab and risankizumab in adults with psoriatic arthritis who did not respond well to previous TNF inhibitor treatment

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Poland +1

  • Study on Reducing Immunosuppressive Drugs in Adults with Psoriatic Arthritis: Methotrexate Disodium, Abatacept, and Certolizumab Pegol

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy

  • Study on the Effectiveness of Ixekizumab and Methotrexate for Treating Dactylitis in Patients with Psoriatic Arthritis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effects and Safety of Guselkumab for Patients with Active Psoriatic Arthritis

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Estonia Germany Greece +8

  • Study on Deucravacitinib for Patients with Active Psoriatic Arthritis New to Biologic Treatments

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Finland France Hungary Ireland +4

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