Zasocitinib for Psoriatic Arthritis

Recruiting at 130 trial locations

Overseen By Tamar Brionez

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Disqualifiers: Rheumatoid arthritis, Lupus, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment called zasocitinib for individuals with psoriatic arthritis, a condition causing joint pain and skin issues in those with psoriasis. Participants will receive either zasocitinib in two different doses or start with a placebo before switching to zasocitinib. The trial suits individuals who have experienced psoriatic arthritis symptoms for at least three months and have not found success with other treatments. The study will last up to 60 weeks, allowing researchers to monitor the effects over time. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, participants with similar conditions generally tolerated zasocitinib well. Most experienced mild to moderate side effects, such as headaches and mild stomach upset, while only a few had more serious reactions. This suggests that zasocitinib is safe for most people, though it may not be suitable for everyone. The current study, being in a later stage, indicates that zasocitinib has passed earlier safety checks. Researchers are confident in its safety based on previous studies.

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Zasocitinib is unique because it targets the Janus kinase (JAK) pathway, which plays a critical role in the inflammation process associated with psoriatic arthritis. Most treatments for this condition, like TNF inhibitors and IL-17 inhibitors, focus on suppressing different parts of the immune response. Unlike these standard treatments, Zasocitinib’s mechanism directly inhibits JAK enzymes, offering a potentially more precise way to reduce inflammation and joint damage. Researchers are excited about its potential to provide effective relief with a daily oral tablet, which could offer a more convenient option compared to injectable therapies.

What evidence suggests that zasocitinib might be an effective treatment for psoriatic arthritis?

Research has shown that zasocitinib may help treat psoriatic arthritis (PsA). In earlier studies, taking 30 mg or 15 mg of zasocitinib reduced key symptoms in people with active PsA. Specifically, 26.1% of those with skin problems had completely clear skin after 12 weeks on the 30 mg dose. Another study found that 67% of patients taking the 30 mg dose and 68% taking the 15 mg dose experienced significant improvement in their condition. In this trial, participants will receive either Zasocitinib Dose A, Dose B, or a placebo followed by one of the doses, to evaluate its effectiveness in managing PsA symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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

For the past two months, have your psoriasis plaques stayed about the same in size, location, and appearance?

Does your plaques cover at least 10% of your body? Examples include 1 arm, half your leg, your chest, your abdomen, your upper back, your lower back, or your entire head.

Over the past month, have most of your plaques been thick, red, and scaly enough to itch, hurt, or bother your daily activities?

Exclusion Criteria

Have you ever been told you have another inflammatory arthritis (for example rheumatoid arthritis, lupus, gout, or ankylosing spondylitis)?

Do you use more than 10 mg of prednisone (or an equivalent steroid) daily?

Have you taken any biologic or JAK-inhibitor medicines (such as Humira, Cosentyx, Stelara, Rinvoq) in the last 8 weeks?

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40615297/

Highly selective tyrosine kinase 2 inhibition with zasocitinib ... Conclusions: Here, 30 mg and 15 mg zasocitinib demonstrated efficacy across core domains in patients with active PsA with no new safety signals.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003496725010416

Highly selective tyrosine kinase 2 inhibition with zasocitinib ... At week 12, 26.1% of patients with skin involvement treated with 30 mg of zasocitinib experienced complete skin clearance (PASI 100), and 32.8% achieved clear ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06671483

NCT06671483 | A Study of Zasocitinib in Adults With ... 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 ...

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2822710

Tyrosine Kinase 2 Inhibition With Zasocitinib in Psoriasis Treatment-emergent adverse events were reported for 53% to 62% of zasocitinib-treated and 44% of placebo-treated patients, with no dose ...

5. psoriasis-hub.com psoriasis-hub.com/medical-information/zasocitinib-tak-279-in-psoriasis-results-from-a-phase-iib-trial

Zasocitinib (TAK-279) in psoriasis: Results from a phase IIb ... At 12 weeks, 67% of patients on 30 mg zasocitinib, 68% on 15 mg, 44% on 5 mg, and 18% on 2 mg achieved the primary endpoint of a ≥75% ...