Zasocitinib for Psoriatic Arthritis
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Takeda
Disqualifiers: Rheumatoid arthritis, Lupus, Fibromyalgia, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to certain medications, which might imply that some current treatments could be continued. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the drug Zasocitinib for treating psoriatic arthritis?
Tofacitinib, a similar drug to Zasocitinib, has been shown to effectively manage psoriatic arthritis by improving symptoms like joint pain and skin issues, and it works well for patients who haven't responded to other treatments. This suggests that Zasocitinib might also be effective for psoriatic arthritis.
12345What safety data exists for Zasocitinib in humans?
There is no specific safety data available for Zasocitinib, but similar drugs like tofacitinib, which are also Janus kinase inhibitors, have been studied for safety in conditions like psoriatic arthritis and rheumatoid arthritis. These studies have shown some safety concerns, especially in older patients with additional heart risk factors, but generally indicate an acceptable safety profile for these types of medications.
678910Eligibility Criteria
Adults with active psoriatic arthritis who haven't used biologic medicines can join this trial. They must have symptoms for at least 3 months, meet specific arthritis criteria, and show signs of active joint inflammation. Those who didn't respond well to NSAIDs or conventional drugs are eligible.Inclusion Criteria
I didn't improve after taking NSAIDs or csDMARDs.
I have been diagnosed with Psoriatic Arthritis according to CASPAR criteria.
I have had symptoms of Psoriatic Arthritis for at least 3 months.
+3 more
Exclusion Criteria
Participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
I do not have conditions like rheumatoid arthritis or lupus that could affect the treatment's evaluation.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either zasocitinib, active comparator, or placebo for up to 52 weeks
52 weeks
Initial Evaluation
Evaluation of primary and secondary outcomes, including ACR20, ACR50, and PASI responses at Week 16
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 weeks
Participant Groups
The study tests Zasocitinib's effectiveness in treating psoriatic arthritis compared to an active comparator or placebo over a period of up to 60 weeks. Participants will be randomly assigned to receive one of the treatments.
4Treatment groups
Experimental Treatment
Active Control
Group I: Zasocitinib Dose BExperimental Treatment1 Intervention
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Group II: Zasocitinib Dose AExperimental Treatment1 Intervention
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Group III: Placebo + ZasoctinibExperimental Treatment2 Interventions
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
Group IV: Active Comparator Dose CActive Control1 Intervention
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
First OC Dermatology Research Inc.Fountain Valley, CA
West Broward Rheumatology Associates, Inc.Tamarac, FL
Klein & Associates, M.D., P.A.Hagerstown, MD
West Texas Clinical ResearchLubbock, TX
More Trial Locations
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Who Is Running the Clinical Trial?
TakedaLead Sponsor
References
Effectiveness and safety of generic tofacitinib in spondyloarthritis: A real-world retrospective analysis from India. [2023]Clinical trial evidence demonstrates the efficacy of tofacitinib in ankylosing spondylitis and psoriatic arthritis (PsA). Real-world data from spondyloarthritis (SpA) patients are scarce; there are few reports of its effectiveness and safety from low- to middle-income countries like India, despite its widespread usage.
Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives. [2023]Tofacitinib is an oral Janus kinase inhibitor approved for the treatment of psoriatic arthritis (PsA). It provides an alternative option for patients who have had an inadequate response and tolerance to other disease modifying antirheumatic drugs (DMARDs). It has demonstrated comparable efficacy to biologics, is effective in the management of treatment resistant disease, and is reported to improve enthesitis, dactylitis, and radiographic progression. Tofacitinib is also associated with an increased risk of serious infections, malignancy, and laboratory abnormalities. There is currently a large armamentarium of therapies for psoriatic arthritis, and choosing among treatments can be challenging. Due to this wide selection, a thorough assessment of psoriatic disease phenotype, patient preference, disease presentation, and comorbidities is critical. This review addresses key considerations in patient selection for the treatment of PsA with tofacitinib.
Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies. [2023]To compare achievement of Disease Activity Index in Psoriatic Arthritis (DAPSA) remission (REM)/low disease activity (LDA) with very low disease activity (VLDA)/minimal disease activity (MDA) targets in tofacitinib-treated patients with psoriatic arthritis (PsA).
Tofacitinib: A Review in Psoriatic Arthritis. [2020]Tofacitinib (Xeljanz®) is the first Janus kinase (JAK) inhibitor approved at a dosage of 5 mg twice daily (BID) in the EU and the USA for the treatment of active psoriatic arthritis (PsA), where it is indicated in combination with methotrexate for patients who have had an inadequate response or who have been intolerant to a prior therapy with a disease-modifying antirheumatic drug (DMARD). Two well-designed phase III trials (OPAL Broaden and OPAL Beyond) in patients with PsA with or without prior tumour necrosis factor inhibitor (TNFi) therapy showed that tofacitinib 5 mg BID (co-administered with methotrexate or another approved conventional synthetic DMARD) significantly improved the key clinical signs/symptoms and disability associated with PsA after 3 months of treatment, while also improving skin psoriasis, enthesitis, dactylitis, physical function and fatigue. According to interim data, the improvements in clinical signs/symptoms were maintained for up to 30 months in the ongoing long-term extension study OPAL Balance, with minimal radiographic progression seen after 12 months' therapy in the OPAL Broaden study. Tofacitinib 5 mg BID had an acceptable tolerability profile, with low incidences of serious infections, malignancies, cardiovascular events and gastrointestinal perforations over 36 months. Changes in laboratory parameters generally remained stable over 36 months of treatment. Although further studies are required to more definitively establish its efficacy and safety, currently available evidence indicates that tofacitinib expands the treatment options available for the treatment of PsA in patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. [2021]To describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.
Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis. [2023]The safety of tofacitinib in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) has been demonstrated in clinical studies of ≤ 4 and 9.5 years, respectively. Post-marketing surveillance (PMS) data for tofacitinib from spontaneous and voluntary adverse event (AE) reports have been published for RA, but not PsA. To inform the real-world safety profile of tofacitinib in PsA, we evaluated AE reports submitted to the Pfizer safety database (including RA data for context).
Janus Kinase Inhibitors: Safety in Patients With Psoriatic Arthritis. [2022]Janus kinase inhibitors (JAKi; or Jakinibs) have become widely prescribed around the world for a variety of immune-mediated inflammatory diseases, including psoriatic arthritis. A previous noninferiority surveillance study of patients aged > 50 years with rheumatoid arthritis and ≥ 1 additional cardiac risk factor raised a number of safety concerns. This review focuses on available safety data from peer-reviewed publications, as well as the most recent presentations from major conferences highlighting JAKi-associated adverse effects. The safety data for several types of JAKi are reviewed. The latest available safety data for tofacitinib, upadacitinib, filgotinib, deucravacitinib, and brepocitinib is presented. In addition, the findings from the oral surveillance study will be discussed to put safety concerns into context.
Small molecule therapy for managing moderate to severe psoriatic arthritis. [2018]The majority of psoriatic arthritis (PsA) patients experience a good clinical response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologic therapies (bDMARDs). However, treatment failure with these drugs can represent a relevant clinical problem. Moreover, in daily clinical practice, the appropriate identification of patients eligible for these agents can be conditioned by numerous aspects, mainly represented by comorbidities, such as history of malignancies, chronic and recurrent infectious diseases. Areas covered: We searched in the PUBMED database and review published data on the efficacy and safety profile of the small molecules, inhibitor of phosphodiesterase 4, apremilast, and of JAK/STAT pathways, tofacitinib, in PsA. Moreover, we report data on the other JAK inhibitor, baricitinib, and the A(3) adenosine receptors agonist, CF101, emerging by studies conducted in psoriasis patients. Expert opinion: In Psoriatic Arthritis, apremilast appears promising for PsA and recent studies have shown a good efficacy and an acceptable safety profile. Data on tofacitinib in PsA are limited. Studies on the small molecules, baricitinib and CF101 are still incomplete and limited to trials conducted in Rheumatoid Arthritis and in psoriasis. Further studies on small molecules and on their underlining mechanisms are advocated in PsA.
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. [2022]This integrated analysis describes the safety profile of upadacitinib, an oral Janus kinase inhibitor, at 15 and 30 mg once daily for up to 3 years of exposure in patients with active psoriatic arthritis (PsA) who had a prior inadequate response or intolerance to ≥ 1 non-biologic or biologic disease-modifying antirheumatic drug.
Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review. [2022]To systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA).