Zasocitinib for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the safety and effectiveness of zasocitinib for treating psoriatic arthritis, a chronic condition causing joint pain and skin issues. Participants from earlier studies will continue taking zasocitinib in this long-term study to assess its performance over two years. Those who completed a previous 1-year treatment study for psoriatic arthritis might be eligible to join. Participants will receive one of two daily doses of zasocitinib. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that zasocitinib is likely to be safe for humans?
Previous studies have shown zasocitinib to be safe. Research indicates that both 30 mg and 15 mg doses effectively treated psoriatic arthritis without introducing new safety concerns. These studies also found that the safety results for zasocitinib in patients with psoriatic conditions matched those in earlier trials with psoriasis patients and healthy volunteers.
Additionally, another study reported that patients taking up to 30 mg daily found the treatment easy to tolerate. While some participants experienced mild side effects, no serious safety issues were linked to the drug. These findings suggest that zasocitinib is generally well-tolerated and considered safe for treating conditions like psoriatic arthritis.12345Why do researchers think this study treatment might be promising?
Zasocitinib is unique because it targets specific enzymes called Janus kinases (JAKs), which play a role in the inflammation process associated with psoriatic arthritis. Unlike traditional treatments, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) that broadly reduce inflammation, Zasocitinib offers a more targeted approach, potentially leading to fewer side effects. Researchers are excited about Zasocitinib due to its novel mechanism of action and its potential to provide relief more effectively while minimizing the impact on the immune system compared to conventional 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). One study found that taking 30 mg or 15 mg doses of zasocitinib reduced symptoms in people with active PsA, with no new safety issues identified. In this trial, participants will receive either Zasocitinib Dose A or Dose B. Another study on psoriasis, a related skin condition, reported that about 70% of patients achieved clear or almost clear skin. Higher doses of zasocitinib led to noticeable improvements in skin condition by week 12. These results suggest that zasocitinib could provide significant benefits for people with PsA.12467
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This trial is for adults with psoriatic arthritis who have finished a previous 1-year study of zasocitinib without major issues and are considered by their doctor to benefit from continued treatment. Participants must be at least 18 years old (19 in South Korea).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zasocitinib (lower or higher dose) once a day for up to 104 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Zasocitinib
Trial Overview
The study tests the long-term safety and effectiveness of daily zasocitinib (at different doses) in people with psoriatic arthritis over about two years. Everyone in this extension study receives zasocitinib.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.
Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
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
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.
Takeda's Zasocitinib Delivered Rapid and Durable Skin ...
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies ...
POS0107 ZASOCITINIB (TAK-279), A HIGHLY SELECTIVE ...
Higher doses of zasocitinib (15 and 30 mg) achieved higher rates of MDA and robust efficacy across all skin endpoints compared with placebo by Week 12.
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who ...
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 ...
Highly selective tyrosine kinase 2 inhibition with zasocitinib ...
Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b ...
Highly selective tyrosine kinase 2 inhibition with zasocitinib ...
Safety results were consistent with data previously reported in patients with plaque psoriasis and healthy volunteers [16,38]. The lack of safety events ...
7.
the-rheumatologist.org
the-rheumatologist.org/article/zasocitinib-in-phase-3-trials-for-psoriatic-arthritis/Zasocitinib in Phase 3 Trials for Psoriatic Arthritis
In a phase 2b trial in patients with psoriasis or PsA, zasocitinib had a favorable safety and tolerability profile at doses of up to 30 mg once daily.1 Patients ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.