Zasocitinib for Plaque Psoriasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a medication called zasocitinib for treating moderate-to-severe plaque psoriasis in children and teenagers. Initially, the trial will include teenagers, who will receive either zasocitinib or a placebo (a pill with no active medicine) for comparison. Later, younger children will join and receive zasocitinib based on their weight. This trial suits children and teenagers with stable plaque psoriasis for at least six months who need treatment beyond creams or light therapy. Participants must visit the study site several times over approximately four years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to a potentially effective treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take systemic treatments for immune-related diseases, except for NSAIDs, during the trial.
Is there any evidence suggesting that zasocitinib is likely to be safe for children and teenagers?
Previous studies have generally shown that patients tolerate zasocitinib well. Research indicates that its safety aligns with earlier findings, revealing no new or unexpected side effects. This information comes from studies involving patients with plaque psoriasis, a skin condition causing red, scaly patches. Although no treatment is risk-free, available data suggests that zasocitinib is as safe as other similar treatments studied before.123
Why do researchers think this study treatment might be promising for plaque psoriasis?
Zasocitinib is unique because it targets plaque psoriasis through a novel mechanism of action, focusing on specific immune pathways involved in the condition. Unlike traditional treatments like biologics or topical steroids, which often target broader immune responses or symptoms, zasocitinib offers a more targeted approach. This specificity could lead to fewer side effects and improved effectiveness for younger patients, like children and adolescents, who are part of the trial. Researchers are excited because this could mean faster relief and a better safety profile for a group that typically has limited treatment options.
What evidence suggests that zasocitinib might be an effective treatment for plaque psoriasis?
Research has shown that zasocitinib holds promise for treating moderate-to-severe plaque psoriasis. In this trial, participants will receive different doses of zasocitinib based on age and weight. Studies found that over half of the patients achieved clear or almost clear skin after using zasocitinib. By week 16, more than 30% of patients had completely clear skin. The treatment was well-tolerated, with most people experiencing no serious side effects. These results suggest that zasocitinib could effectively manage plaque psoriasis.12456
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This study is for children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis. They must have been diagnosed at least 6 months prior, have stable psoriasis without significant changes recently, and need phototherapy or systemic therapy. Teens must weigh at least 40 kg.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive either zasocitinib or placebo for the first 16 weeks, followed by zasocitinib for the remainder of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Zasocitinib
Trial Overview
The trial tests Zasocitinib's effectiveness and safety in young patients with plaque psoriasis over up to four years. Initially, teens may receive the drug or a placebo for 16 weeks; afterwards, all participants get Zasocitinib. Younger kids start directly on the drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.
Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.
Participants (Adolescent) aged 12 to less than (\<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.
Participants in Cohort 1 (Adolescent aged 12 to \<18 years) and Cohort 2 (Children aged 4 to \<12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.
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
1.
takeda.com
takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-once-daily-pill/Takeda's Zasocitinib Landmark Phase 3 Plaque Psoriasis ...
Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe ...
Zasocitinib Hits Phase 3 End Points in Plaque Psoriasis
Clinically meaningful efficacy was observed, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI ...
Oral Psoriasis Candidate Performs Well in Phase 3 Trials
Zasocitinib was generally well-tolerated. The safety and tolerability profile of zasocitinib in the phase 3 studies remained consistent with ...
4.
dermatologytimes.com
dermatologytimes.com/view/phase-3-data-position-zasocitinib-as-a-potential-new-oral-option-for-psoriasisPhase 3 Data Position Zasocitinib as a Potential New Oral ...
This oral daily therapy achieved PASI-90 in over 50% of patients by week 16, and PASI-100 in around 30% of patients by week 16," said ...
5.
psoriasis-hub.com
psoriasis-hub.com/medical-information/zasocitinib-tak-279-in-psoriasis-results-from-a-phase-iib-trialZasocitinib (TAK-279) in psoriasis: Results from a phase IIb ...
Improved outcomes were seen with higher doses of zasocitinib. Notably, PASI 100, indicating complete skin clearance, was achieved by 33%, 15%, ...
NCT06973291 | A Study Comparing Zasocitinib (TAK-279) ...
The main aim of this study is to assess whether zasocitinib works better than deucravacitinib in treating participants with moderate-to-severe plaque ...
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