Psoriasis ArthritisPhase 4GUPAINNCT06974474
Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.
A Phase 4 study testing Guselkumab in people with Psoriasis Arthritis, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis Arthritis
- What is being tested?
- Guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2024to 27 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A man or a woman at least 18 and no more than 80 years of age;
- Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months the enrolment and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening;
- Inadequate response or intolerance of standard treatment (namely, methotrexate and/or TNF inhibitors);
- At least 3 months of non-biologic DMARDs (limited to methotrexate ≤25 mg/week, sulfasalazine ≤3 g/day, hydroxychloroquine ≤400 mg/day, and leflunomide ≤20mg/day) or at least 4 weeks of NSDAIDs for psoriatic arthritis;
- Patient eligible for Guselkumab (both monotherapy or combination therapy with methotrexate) treatment according to international recommendations, national and regional regulatory authorities, and EMA datasheet;
- VAS pain major than 15 mm at the enrolment;
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- DAPSA major than 14 at the enrolment;
- Have at least 1 of the PsA subsets: oligoarticular or polyarticular PsA subset, distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, spondylitis with peripheral arthritis;
- Peripheral tender joints ≥ 1
- Peripheral swollen joints ≥ 1
- C-reactive protein ≥ 0.3 mg/dL
- Involvement (namely, swollen joint) of wrists or knees;
- Subjects naïve to bDMARDs or previously treated with up to 2 anti-tumor necrosis factor (TNFα) agents, discontinued for lack of benefit to an anti-TNFα therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and/or at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; Intolerance to an anti-TNFα biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars); If no intolerance or lack of benefit, the reason for discontinuation must be documented;
- If currently using non-biologic DMARDs (limited to methotrexate [MTX], sulfasalazine [SSZ], hydroxychloroquine [HCQ], or leflunomide [LEF]), subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before the first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using a MTX, SSZ, or HCQ, must have not received for at least 4 weeks before the first administration of study agent. If currently not using LEF, must not have received for at least 12 weeks before the first administration of study agent. If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. If receiving SSZ, the dose must be ≤ 3g/day. If receiving HCQ, the dose must be ≤400 mg/day. If receiving LEF, the dose must be ≤20 mg/day.
- If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before the first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before the first administration of study agent;
- Are willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications, and acupuncture within 2 weeks before the first study agent administration and through Week 52;
- Signed informed consent.
Who cannot join
- Diagnosis of fibromyalgia according to ACR 2016 criteria;
- Subjects with inflammatory diseases that might confound the evaluations of benefit of Guselkumab therapy, including but not limited to RA, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease;
- Patients who received more than 2 anti-TNFα agents; - Has received an anti-TNF agent within the following timeframes: Infliximab (or its biosimilars) or golimumab (intravenous) within 8 weeks before the first administration Guselkumab; Golimumab (subcutaneous), adalimumab (or its biosimilars) or certolizumab pegol within 6 weeks before the first administration of study agent; Etanercept (or its biosimilars) within 4 weeks before the first administration of study agent;
- Has previously been treated with Guselkumab; - Diagnosis of psychiatric disorder according to DSM-V; - Pregnancy or lactation;
- Systemic or intra-articular glucocorticoids in the last 3 months;
- Has previously received any biologic treatment (other than anti-TNFα agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment;
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- Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor, as well as apremilast;
- Has previously received any systemic immunosuppressants (e.g., azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent;
- Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent;
- Is currently receiving 2 or more allowed non-biologic DMARDs at baseline;
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), genitourinary, or metabolic disturbances;
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (e.g., unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening;
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study agent administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first Guselkumab administration);
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative diseases, such as lymphadenopathy or splenomegaly;
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., bronchiectasis), recurrent urinary tract infection (e.g., recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (e.g., mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers;
- Has a transplanted organ (with exception of a corneal transplant \>3 months before the first administration of the study agent);
- Has a history of an infected joint prosthesis, or has ever received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced;
- Has or has had a serious infection (e.g., sepsis, pneumonia, or pyelonephritis) or has been hospitalized or received IV antibiotics for an infection within 2 months before screening;
- Has or has had a herpes zoster infection within 2 months before screening;
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 12 weeks after receiving the last administration of the study agent;
- Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of the study agent;
- Has had a BCG vaccination within 12 months of screening;
- Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies, or antibody fragments;
- Subject has known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients;
- Has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening;
- Has a chest radiograph within 3 months prior to the first administration of the study agent that shows an abnormality suggestive of a malignancy, significant cardiovascular or pulmonary disease, or current active infection, including TB;
- Has ever had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, pneumocystosis, aspergillosis);
- Is infected with human immunodeficiency virus (HIV, a confirmed positive serology for HIV antibody);
- Tests positive for hepatitis B virus (HBV) infection at screening; - Is seropositive for antibodies to hepatitis C virus (HCV) at screening, unless the subject had 2 negative HCV ribonucleic acid (RNA) test results at least 6 months apart prior to screening and has a third negative HCV RNA test result at screening;
- Has had major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before the screening, or will not have fully recovered from such surgery, or has such major surgery planned during the time the subject is expected to participate in the study; NOTE: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Immunorheumatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
Luca Navarini, MD, +3906225411779, l.navarini@policlinicocampus.it
Francesca Scintu, Biologist, +3906225411779, f.scintu@policlinicocampus.it
About this study
Official title: Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study
Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain sensitization. Although chronic pain is the most common symptom of PsA, few is known about the mechanisms driving it. From this point of view, the interactions between immune cells and nociceptors in the context of inflammation-related pain are emerging as a hot topic. Many studies suggested that IL-23/IL-17 pathway may play a pivotal role in this regard. This is consistent with data currently available regarding Guselkumab in PsA. Indeed, according to DISCOVER 1 and DISCOVER 2, two randomized phase III trials, patients receiving Guselkumab achieved, among others, minimal disease activity state, significant improvement in the SF-36 physical component score, and visual analog scale of pain. This study proposal aims to evaluate the potential role of Guselkumab in modulating pain perception in PsA patients from a molecular, cellular, and electrophysiological point of view.
- Conditions
- Psoriasis Arthritis
- Being tested
- Guselkumab
- Keywords
- Guselkumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Guselkumab
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Other | Patients with Psoriatic Arthritis undergoing Guselkumab treatment Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain-related genes mRNA
Change in synovial transcriptomic profiling of pain-related genes (as described by Perkins JR et al, Pain 2013; Bratus-Neuenschwander A et al, Genes 2018) in PsA patients before and after six months of treatments with Guselkumab.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start18 Jun 2024
- Primary completion27 Nov 2025 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974474
- Sponsor's protocol ID
- CNTO1959PSA4016
- Acronym
- GUPAIN
- Status last verified
- May 2024
- First submitted
- 25 Sep 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06974474
- Acronym / sponsor ID
- GUPAIN / CNTO1959PSA4016
- Conditions
- Psoriasis Arthritis
- Keywords
- Guselkumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 27 Nov 2025 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain sensitization. Although chronic pain is the most common symptom of PsA, few is known about the mechanisms driving it. From this point of view, the interactions between immune cells and nociceptors in the context of inflammation-related pain are emerging as a hot topic. Many studies suggested that IL-23/IL-17 pathway may play a pivotal role in this regard. This is consistent with data currently available regarding Guselkumab in PsA. Indeed, according to DISCOVER 1 and DISCOVER 2, two randomized phase III trials, patients receiving Guselkumab achieved, among others, minimal disease activity state, significant improvement in the SF-36 physical component score, and visual analog scale of pain. This study proposal aims to evaluate the potential role of Guselkumab in modulating pain perception in PsA patients from a molecular, cellular, and electrophysiological point of view.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | Other | Drug: GuselkumabPatients with Psoriatic Arthritis undergoing Guselkumab treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A man or a woman at least 18 and no more than 80 years of age;
- Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months the enrolment and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening;
- Inadequate response or intolerance of standard treatment (namely, methotrexate and/or TNF inhibitors);
- At least 3 months of non-biologic DMARDs (limited to methotrexate ≤25 mg/week, sulfasalazine ≤3 g/day, hydroxychloroquine ≤400 mg/day, and leflunomide ≤20mg/day) or at least 4 weeks of NSDAIDs for psoriatic arthritis;
- Patient eligible for Guselkumab (both monotherapy or combination therapy with methotrexate) treatment according to international recommendations, national and regional regulatory authorities, and EMA datasheet;
Key exclusion criteria (30 listed)
- Diagnosis of fibromyalgia according to ACR 2016 criteria;
- Subjects with inflammatory diseases that might confound the evaluations of benefit of Guselkumab therapy, including but not limited to RA, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease;
- Patients who received more than 2 anti-TNFα agents; - Has received an anti-TNF agent within the following timeframes: Infliximab (or its biosimilars) or golimumab (intravenous) within 8 weeks before the first administration Guselkumab; Golimumab (subcutaneous), adalimumab (or its biosimilars) or certolizumab pegol within 6 weeks before the first administration of study agent; Etanercept (or its biosimilars) within 4 weeks before the first administration of study agent;
- Has previously been treated with Guselkumab; - Diagnosis of psychiatric disorder according to DSM-V; - Pregnancy or lactation;
- Systemic or intra-articular glucocorticoids in the last 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabGuselkumab | Drug | Psoriatic Arthritis |
Primary outcome
pain-related genes mRNA
Time frame: 6 months
Change in synovial transcriptomic profiling of pain-related genes (as described by Perkins JR et al, Pain 2013; Bratus-Neuenschwander A et al, Genes 2018) in PsA patients before and after six months of treatments with Guselkumab.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guselkumab in people with Psoriasis Arthritis, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Navarini, MD (+3906225411779, l.navarini@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain-related genes mRNA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.