Zasocitinib vs Deucravacitinib for Plaque Psoriasis

Recruiting at 126 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must not be taking: Biologics, TNF inhibitors, JAK inhibitors, others

Disqualifiers: Nonplaque psoriasis, Active TB, HIV, 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: Unknown

Duration: 16 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether zasocitinib, a potential new drug, is more effective than the existing treatment, deucravacitinib, for managing moderate-to-severe plaque psoriasis, a skin condition marked by red, scaly patches. Participants will take tablets and capsules daily for 16 weeks to assess their effectiveness. This study suits individuals with chronic plaque psoriasis for over six months who require extensive treatment, such as light therapy or systemic medication. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) for treatments like biologics, topical medications, and some systemic treatments. It's best to discuss your current medications with the trial team to see if any need to be paused.

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

Research has shown that both zasocitinib and deucravacitinib are safe for treating plaque psoriasis.

For zasocitinib, studies found it well-tolerated by patients. Many experienced significant skin improvements, and side effects were generally mild. Specifically, safety data revealed that one-third of patients achieved complete symptom relief without major safety concerns.

Deucravacitinib also maintains a strong safety record over several years. Studies identified no new safety issues, and it remained effective throughout treatment. Patients consistently improved, with few serious side effects reported.

Both treatments have undergone previous studies, providing strong evidence for their safety in treating psoriasis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for plaque psoriasis because they offer potentially new ways to manage the condition. Unlike most current treatments, which often involve topical creams or biologics targeting specific proteins like TNF-alpha, interleukin-17, or interleukin-23, Zasocitinib and Deucravacitinib operate through a different mechanism. Zasocitinib is a Janus kinase (JAK) inhibitor that blocks specific pathways in the immune system, possibly resulting in reduced inflammation and skin cell overproduction. Deucravacitinib, on the other hand, is a tyrosine kinase 2 (TYK2) inhibitor, offering a targeted approach that may have fewer side effects than broader immunosuppressive treatments. These innovative mechanisms could mean more effective symptom control and improved quality of life for patients with plaque psoriasis.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

This trial will compare Zasocitinib and Deucravacitinib for treating plaque psoriasis. Research has shown that Zasocitinib, one of the treatments participants may receive, holds promise for moderate-to-severe plaque psoriasis. Studies found that up to 68% of patients experienced a 75% improvement in their symptoms, with some achieving complete clearance.

Deucravacitinib, another treatment option in this trial, has also proven effective for plaque psoriasis. Specifically, about 67% of patients maintained a 75% improvement in their symptoms over five years. Both treatments target specific proteins that cause inflammation, helping to reduce psoriasis symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults with moderate-to-severe plaque psoriasis for at least 6 months, having a PASI score of 12 or more and an sPGA score of 3 or higher. They should have stable psoriasis without significant changes for the past 6 months and must cover at least 10% of their body surface area. Candidates should be suitable for phototherapy or systemic therapy.

Inclusion Criteria

I have been diagnosed with chronic plaque psoriasis for at least 6 months.

My psoriasis has been stable without major changes for at least 6 months.

My psoriasis covers 10% or more of my body.

Exclusion Criteria

Participant has abnormal laboratory values, significant laboratory abnormalities, or intolerance to venipuncture.

Participant has history of significant drug allergy or known/suspected allergy to specific medications.

Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive either zasocitinib or deucravacitinib, or their respective placebos, daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib
• Zasocitinib

Trial Overview The trial is testing if Zasocitinib is more effective than Deucravacitinib in treating plaque psoriasis. Participants will take either drug or a matching placebo daily for 16 weeks to compare improvements in their condition.

How Is the Trial Designed?

Group I: Zasocitinib or Placebo Experimental Treatment 2 Interventions

Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.

Group II: Deucravacitinib or Placebo Active Control 2 Interventions

Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.

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/40045918/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1l1vNBYu_ed6RIBx4yjiYJ-tnJX2DEnfLu2bT3RUcVLTGoG9AU&fc=None&ff=20250329043238&v=2.18.0.post9+e462414

Deucravacitinib in plaque psoriasis: Four-year safety and ... Deucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2827130

Safety and Efficacy of Deucravacitinib in Moderate to ... Overall, of the 513 patients continuously treated with deucravacitinib, most maintained clinical response rates through 3 years. Meaning The ...

3. news.bms.com news.bms.com/news/details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

New Five-Year Sotyktu (deucravacitinib) Data Show ... Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5), ...

4. academic.oup.com academic.oup.com/bjd/article/190/5/668/7558435

Deucravacitinib in plaque psoriasis: 2-year safety and efficacy ... Deucravacitinib has been shown to improve psoriatic patches and symptoms (such as itching) through 1 year in two global clinical trials in ...

5. jaad.org jaad.org/article/S0190-9622(24)01196-4/fulltext

A subanalysis of the phase 3 clinical trial data Deucravacitinib was effective in patients with scalp involvement in psoriasis regardless of overall baseline disease severity.

6. psoriasis-hub.com psoriasis-hub.com/medical-information/deucravacitinib-in-moderate-to-severe-plaque-psoriasis-5-year-results-from-the-poetyk-pso-1-pso-2-and-lte-trials

Deucravacitinib in moderate-to-severe plaque psoriasis: 5- ... Deucravacitinib demonstrated a consistent safety profile with no new safety signals and sustained clinical efficacy over 5 years. AE, adverse ...

7. skin.dermsquared.com skin.dermsquared.com/skin/article/view/3309

Deucravacitinib in Moderate to Severe Plaque Psoriasis Conclusion: Deucravacitinib demonstrated a consistent safety profile through 5 years with no emergence of any new safety signals. Clinical ...