Select Ongoing Trials Currently Enrolling Patients with Psoriatic Arthritis

The following clinical trials represent a selection of key studies currently recruiting patients with psoriatic arthritis for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help rheumatology practice managers and providers direct eligible patients to one of these clinical trials.

1 Guselkumab in Patients with Active Psoriatic Arthritis Axial Disease

The purpose of this randomized, multicenter, double-blind, placebo- controlled, phase 4 clinical trial is to evaluate the efficacy and safety of guselkumab (Tremfya), an immunoglobulin G1-γ monoclonal antibody that blocks the interleukin-23–mediated signaling pathway, in patients with active psoriatic arthritis (PsA). Patients aged ≥18 years who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at screening, have magnetic resonance imaging confirmed PsA axial disease, have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4, and who have active plaque psoriasis with ≥1 plaques of ≥2 cm in diameter and/or nail changes consistent with psoriasis may be eligible if other criteria are met. Eligible patients will be randomized to receive guselkumab and matching placebo subcutaneously, guselkumab subcutaneously, or matching placebo followed by cross-over to guselkumab subcutaneously, for up to 48 weeks (placebo-controlled period from weeks 0-24 and an active-controlled treatment phase from weeks 24-28).

The primary outcome measure is change from baseline in BASDAI score at week 24. Secondary outcome measures include changes in baselines in Ankylosing Spondylitis Disease Activity Score (DAS) C-Reactive Protein, Disease Activity Index for Psoriatic Arthritis (DAPSA), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Spondyloarthritis Research Consortium of Canada for magnetic resonance imaging sacroiliac joints scores at week 24; the number of participants with adverse events (AEs), reasonably related AEs, serious AEs, and AEs leading to discontinuation; and the number of participants with laboratory abnormalities by maximum toxicity. The study plans to enroll 405 participants throughout the United States and worldwide. For more information, contact Janssen Research & Development Clinical Trials at 1-844-434-4210 or JNJ.CT@sylogent.com. The NLM identifier is NCT04929210.

2 Deucravacitinib versus Placebo in DMARD-Naïve Patients with Active PsA

The purpose of this randomized, double-blind, placebo-controlled, phase 3 clinical trial is to evaluate the efficacy and safety of deucravacitinib (BMS-986165), a selective tyrosine kinase 2 inhibitor, versus placebo in patients with active PsA who are naïve to biologic disease- modifying antirheumatic drugs (DMARDs). Patients aged ≥18 years who meet the CASPAR criteria at screening, have active plaque psoriatic skin lesions or documented medical history of plaque psoriasis at screening, have active arthritis shown by ≥3 swollen joints and ≥3 tender joints at screening and day 1, have a high-sensitivity C-reactive protein (≥3 mg/L) at screening, and who have ≥1 PsA-related hand and/or foot joint erosions on x-ray may be eligible if other criteria are met. Eligible patients will be randomized to receive deucravacitinib or placebo specified dose on specified days.

The primary outcome measure is the proportion of participants meeting the American College of Rheumatology (ACR) improvement of 20% (ACR20) response at week 16. Secondary outcome measures include changes from baseline in DAS 28 with C-reactive protein and HAQ-DI scores, the proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response, the proportion of participants having enthesitis and dactylitis resolution, the proportion of patients having minimal disease activity (MDA), and the incidence of AEs and serious AEs. The study plans to enroll 650 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly and include the NCT number and site number on the first line of the e-mail. If there is no contact information, please e-mail Clinical.Trials@bms.com. The NLM identifier is NCT04908202.

3 Efficacy, Safety, and Tolerability of IV Secukinumab in Active PsA Despite NSAID, DMARD, or anti-TNF Therapy

The purpose of this double-blind, placebo-controlled, parallel-group, randomized, phase 3 clinical trial is to compare the efficacy of intravenous (IV) secukinumab (Cosentyx) with placebo for 16 weeks, and to assess the safety and tolerability of IV secukinumab for up to 52 weeks in patients with active PsA regardless of current or previous nonsteroidal anti-inflammatory drug (NSAID), DMARD, and/or anti-tumor necrosis factor (TNF) therapy. Patients aged ≥18 years with PsA classified by CASPAR criteria with symptoms for ≥6 months of moderate to severe PsA, who have a diagnosis or documented history of active plaque psoriasis, who have received NSAIDs for ≥4 weeks prior to randomization with inadequate control of symptoms or who have stopped due to intolerance to NSAIDs, who are on a stable dose of corticosteroids ≤10 mg daily for at least 2 weeks before randomization, and who are stable for at least 4 weeks before randomization on methotrexate may be eligible if other criteria are met. Eligible patients will be randomized 1:1 to receive secukinumab 6 mg/kg IV at baseline, followed by secukinumab 3 mg/kg IV every 4 weeks starting at week 4; or placebo IV at baseline and at weeks 4, 8, and 12, followed by secukinumab 3 mg/kg IV every 4 weeks starting at week 16.

The primary outcome measure is the proportion of participants achieving ACR50 response criteria by week 16. Secondary outcome measures include the proportion of participants achieving ACR20 criteria, MDA, and PASI 90 response; changes in baseline for Psoriatic Arthritis Disease Activity Score, HAQ-DI, the Short Form 36 (SF36)-Physical Component Summary, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and the Modified Nail Psoriasis Severity Index at week 16; and the incidence of clinically significant laboratory values and serious AEs in participants receiving IV secukinumab or IV placebo. The study plans to enroll 380 participants throughout the United States and worldwide. For more information, contact Novartis Pharmaceuticals at 1-888-669-6682, or Novartis.email@novartis.com. The NLM identifier is NCT04209205.

4 Efficacy, Safety, and Tolerability of Apremilast in Early Oligoarticular PsA Despite Initial Stable Treatment with NSAIDs or DMARDs

The purpose of this multicenter, double-blind, placebo-controlled, parallel-group, randomized phase 4 clinical trial is to evaluate the efficacy, safety, and tolerability of apremilast (Otezla) for the treatment of patients with early oligoarticular PsA despite initial stable treatment with either NSAIDs and/or ≥1 conventional synthetic DMARDs. Patients aged ≥18 years who have been diagnosed with PsA for ≥3 months but less than 5 years duration, who have swollen joint count >1 and tender joint count ≤4, who are receiving stable doses of protocol allowed PsA medications, and who are in general good health as judged by the investigator may be eligible if other criteria are met. Eligible patients will be randomized to receive either apremilast 30 mg orally twice daily for up to 48 weeks with or without stable doses of NSAIDs, glucocorticoids, and 1 conventional synthetic DMARD; or placebo twice daily for up to 24 weeks with or without stable doses of background therapy, followed by apremilast until week 48.

The primary outcome measure is the proportion of participants who achieve a clinical state of MDA per MDA-Joints by week 16. Secondary outcome measures include the proportion of patients with clinical DAPSA remission or low disease activity, swollen joint count and tender joint count ≤1, improvement in Psoriatic Arthritis Disease Activity Score, improvement in Patient Global Assessment of Disease Activity and Pain; and the type, frequency, severity, and relationship of AEs to the investigational product, and the number of participants discontinuing the investigational product due to any AE. The study plans to enroll 330 participants throughout the United States and worldwide. For more information, contact the Amgen Call Center at 1-866-572-6436, or medinfo@amgen.com. The NLM identifier is NCT03747939.

5 Tildrakizumab-asmn versus Placebo in Active PsA Previously Treated with TNF Inhibitors

The purpose of this multicenter, double-blind, placebo-controlled, randomized phase 3 clinical trial is to demonstrate the efficacy and safety of tildrakizumab-asmn (Ilumya) compared with placebo in patients with active PsA who have been previously treated with TNF inhibitors for the treatment of PsA or psoriasis. Patients aged ≥18 years with active PsA, with rheumatoid factor–negative and anticyclic citrullinated peptide antibody–negative tests, and who have had previous exposure to TNF inhibitors may be eligible if other criteria are met. Eligible patients will be randomized to receive either tildrakizumab or placebo 1 mL subcutaneously.

The primary outcome measure is the proportion of participants who achieve ACR20 from baseline. Secondary outcome measures include the proportion of participants achieving ACR50, ACR70, and PASI 75 among participants with body surface area ≥3% at baseline; and changes from baseline van der Heijde modified total sharp score, ACR Response Criteria Components Score, BASDAI, Leeds Enthesitis Index, and Leeds Dactylitis Index. Other outcome measures include the proportion of participants achieving a DAS C-reactive protein <3.2, changes from baseline in FACIT-Fatigue, and changes from baseline in metabolic biomarker levels. The study plans to enroll 472 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly or the Head of Clinical Development at clinical.trials@sparcmail.com. The NLM identifier is NCT04314544.

6 Deucravacitinib versus Placebo in Patients with PsA Previously Treated with TNF-α Inhibitor or Naïve to Biologic DMARDs

The purpose of this multicenter, randomized phase 3 clinical trial is to evaluate the efficacy and safety of deucravacitinib in the treatment of patients with active PsA who are naïve to biologic DMARDs or who have had previous treatment with a TNF-α inhibitor. Patients aged ≥18 years who have been diagnosed with PsA for ≥3 months and meet CASPAR criteria, who have active plaque psoriatic skin lesions, who have ≥3 swollen joints and ≥3 tender joints at screening and on day 1, and who have a high-sensitivity C-reactive protein ≥3 mg/dL at screening may be eligible if other criteria are met. Eligible patients will be randomized to receive deucravacitinib or placebo plus apremilast (Otezla) specified dose on specified days.

The primary outcome measure is the proportion of participants meeting ACR20 at week 16. Secondary outcome measures include change from baseline DAS 28 C-reactive protein, HAQ-DI, SF36 Physical Component Survey, FACIT-Fatigue, SF36 Mental Component Summary, DAPSA, and Patient-Reported Outcome Measures Information System-Sleep Disturbance; and incidence of AEs and serious AEs. This study plans to enroll 700 participants throughout the United States and worldwide. For more information, contact the sites directly. If there is no contact information, e-mail Clinical.Trials@bsm.com and include the NCT number and site number in the first line of the e-mail. The NLM identifier is NCT04908189.

7 Guselkumab for the Inhibition of Radiographic Progression in Active PsA

The purpose of this multicenter, randomized phase 3b clinical trial is to evaluate the efficacy and safety of guselkumab (Tremfya) in improving the signs and symptoms and inhibiting radiographic progression in participants with active PsA. Patients aged ≥18 years diagnosed with active PsA ≥6 months despite previous non-biologic DMARD, apremilast (Otezla), and/or NSAID therapy, who have ≥3 swollen joints and ≥3 tender joints at screening, have C-reactive protein ≥0.3 mg/dL, ≥2 joints with erosions on baseline radiographs of the hands and feet, and who have ≥1 PsA subsets may be eligible if other criteria are met. Eligible patients will be randomized to receive either guselkumab and placebo subcutaneously, guselkumab monotherapy subcutaneously, or placebo followed by guselkumab subcutaneously.

The primary outcome measure is the percentage of participants who achieve ACR20 response at week 24. Secondary outcome measures include the change from baseline in PsA modified van der Heijde-Sharp Total Score; the number of participants with AEs, serious AEs, reasonably related AEs, AEs leading to discontinuation of study, and AEs temporally associated with an infusion and injection-site reactions; number of participants with change in baseline in clinical laboratory abnormalities and infections; number of participants with maximum Common Terminology Criteria for Adverse Events toxicity grade laboratory values; and the serum guselkumab concentration and number of participants with anti-guselkumab antibodies. This study plans to enroll 950 participants throughout the United States and worldwide. For more information, contact Janssen Research & Development at 1-844-434-4210 or JNJ.CT@sylogent.com. The NLM identifier is NCT04882098.

8 Certolizumab Pegol in Children and Adolescents with Active Polyarticular JIA

The purpose of this multicenter, open-label, phase 3 clinical trial is to assess the pharmacokinetics, safety, and efficacy of certolizumab pegol (Cimzia) in children and adolescents with moderate-to-severe active polyarticular juvenile idiopathic arthritis (JIA). Patients aged 2-17 years who weigh ≥10 kg (22 lbs) at baseline, who have signs and symptoms consistent with a diagnosis of JIA according to the International League of Associations in Rheumatology Classification of Juvenile Idiopathic Arthritis 2001 (polyarthritis rheumatoid factor–positive and –negative, extended oligoarthritis, juvenile PsA, and enthesitis-related arthritis), who have ≥5 joints with active arthritis, and who have had an inadequate response to, or intolerance to, ≥1 DMARDs may be eligible if other criteria are met. Eligible patients will receive 3 loading doses of certolizumab pegol followed by certolizumab pegol subcutaneously as a fixed dose based on weight every 2 weeks or every 4 weeks throughout the study.

The primary outcome measures are certolizumab pegol plasma concentration at weeks 16 and 48, anti-certolizumab pegol antibodies at weeks 16 and 48, incidence of serious treatment-emergent AEs up to 12 weeks after final dose, and incidence of treatment-emergent AEs leading to permanent withdrawal of the study up to 12 weeks after final dose. Secondary outcome measures include pediatric ACR30, ACR50, ACR70, and ACR90 responses at week 16. This study plans to enroll 193 participants throughout the United States and worldwide. For more information, contact UCB Cares at 1-844-599-2273 or UCBCares@ucb.com. The NLM identifier is NCT01550003.

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