Zasocitinib for Psoriatic Arthritis

Recruiting at 122 trial locations

Overseen By Tamar Brionez

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 52 weeks

600 Participants Needed

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 based on their previous experience with specific treatments. The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults over 18 with active Psoriatic Arthritis (PsA) who have had symptoms for at least 3 months and meet specific criteria, including having a certain number of tender and swollen joints, as well as psoriasis skin or nail lesions. Participants may have had an inadequate response to NSAIDs, conventional synthetic DMARDs, or up to two biologic DMARDs.

Inclusion Criteria

I have been diagnosed with Psoriatic Arthritis according to CASPAR criteria.

I have active arthritis with at least 3 tender and 3 swollen joints.

I am 18 years or older and can sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either zasocitinib or placebo for up to 52 weeks, with placebo participants switching to zasocitinib after 16 weeks

52 weeks

Weekly visits for the first 16 weeks, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Zasocitinib

Trial Overview The trial is testing Zasocitinib's effectiveness in treating PsA compared to a placebo. It aims to see how well it works based on participants' previous treatments. The study will last up to 60 weeks with patients randomly assigned either the drug or placebo.

Participant Groups

Group I: Zasocitinib Dose B Experimental Treatment 1 Intervention

Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

Group II: Zasocitinib Dose A Experimental Treatment 1 Intervention

Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

Group III: Placebo + Zasoctinib Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier