TAK-279 for Plaque Psoriasis

No longer recruiting at 169 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Disqualifiers: Other psoriasis, Recent infection, others

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: 1

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, TAK-279 (a small molecule TYK2 inhibitor), in reducing skin plaques for individuals with moderate-to-severe plaque psoriasis. Participants will randomly receive TAK-279, an already-approved treatment called apremilast, or a placebo (a pill with no active medicine). The goal is to determine if TAK-279 is more effective than the placebo in improving skin condition. This trial suits individuals who have had plaque psoriasis for at least six months and require treatments like phototherapy or systemic therapy. 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.

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 coordinators or your doctor.

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

Research has shown that TAK-279, also known as zasocitinib, is generally well-tolerated by people with moderate to severe plaque psoriasis. Studies have found it effective and safe, with no major safety concerns reported in previous trials. This suggests that TAK-279 could be a reliable treatment option for plaque psoriasis.

For apremilast, which is already approved for use, common side effects include diarrhea, nausea, and headaches, affecting more than 5% of users. While these side effects can be unpleasant, they are usually manageable. The existing approval and safety data from long-term studies provide reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TAK-279 for plaque psoriasis because it offers a new mechanism of action compared to standard treatments like biologics and oral systemic drugs. While most treatments target specific proteins involved in inflammation, TAK-279 is designed to inhibit a different pathway, potentially leading to improved skin clearance and fewer side effects. This novel approach could provide faster and more effective relief for patients who haven't responded well to existing therapies.

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

This trial will compare TAK-279 with Apremilast and a placebo for treating plaque psoriasis. Research has shown that TAK-279 looks promising, with many patients experiencing a 75% improvement in their skin, suggesting it could greatly reduce psoriasis plaques. Early trials also found it helps improve skin conditions related to psoriasis in just a few weeks.

Apremilast, another treatment option in this trial, is already an approved treatment for plaque psoriasis. Studies have shown it improves quality of life by reducing itching and skin discomfort. After 16 weeks, many patients taking Apremilast noticed their skin became much clearer. Both treatments offer hope for those dealing with moderate-to-severe plaque psoriasis. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for people who have had plaque psoriasis for at least 6 months and it's moderate to severe. They should be candidates for light therapy or systemic treatment but can't join if they've had other types of psoriasis, recent infections, or previous exposure to TAK-279 or the active comparator.

Inclusion Criteria

I have had plaque psoriasis for at least 6 months.

My condition is moderate to severe.

I am eligible for light or systemic treatment.

Exclusion Criteria

I have had a recent infection.

Other protocol defined inclusion/exclusion criteria apply

I have a type of psoriasis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive TAK-279, placebo, or apremilast for up to 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Apremilast
• Placebo
• TAK-279

Trial Overview The study tests how well a new medication, TAK-279, works in reducing skin plaques compared to an inactive substance (placebo) and an approved drug called Apremilast. Participants will randomly receive one of these treatments over a period of up to 56 weeks.

How Is the Trial Designed?

Group I: TAK-279 Experimental Treatment 1 Intervention

Group II: Apremilast Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Apremilast is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

Approved in European Union as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

Approved in Canada as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

Approved in Japan as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

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

Published Research Related to This Trial

In a phase IIa study involving 212 patients with moderate-to-severe plaque psoriasis, the oral TYK2/Jak1 inhibitor PF-06700841 showed significant improvements in psoriasis severity, with the 30 mg once daily dose achieving the greatest reduction in PASI score at week 12.

The treatment was generally well tolerated, with no cases of herpes zoster or major cardiac events reported, although some patients experienced adverse events leading to discontinuation of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. Forman, SB., Pariser, DM., Poulin, Y., et al.[2021]

Deucravacitinib, a new oral drug that selectively inhibits TYK2, showed significant efficacy in treating moderate-to-severe psoriasis, with over 50% of patients achieving PASI75 at week 16 in two phase 3 trials involving 1688 participants.

The drug was well tolerated with no serious infections or significant side effects reported, indicating a favorable safety profile that could make it a promising option for patients requiring systemic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in the treatment of psoriasis. Estevinho, T., Lé, AM., Torres, T.[2023]

In a study of 77 East Asian patients with advanced BRAF V600-mutant cutaneous melanoma, the combination of dabrafenib and trametinib showed a high objective response rate of 61%, indicating significant efficacy in treating this patient population.

The treatment was generally well-tolerated, with the most common adverse event being pyrexia (fever) occurring in 56% of patients, and serious adverse events were reported in 38%, suggesting that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label, phase IIa study of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. Si, L., Zhang, X., Shin, SJ., et al.[2020]

Deucravacitinib, an oral TYK2 inhibitor, demonstrated significant efficacy in treating moderate to severe plaque psoriasis, with 65.1% of patients achieving a PASI 75 response at week 16 across 6 clinical trials involving 2248 subjects.

The safety profile of deucravacitinib is favorable, with mild adverse events like nasopharyngitis being common, and serious adverse events occurring in only 1.35% to 9.5% of patients, making it a potentially less burdensome treatment option compared to injectable therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. Truong, TM., Pathak, GN., Singal, A., et al.[2023]

In two phase III studies involving 1861 patients with moderate to severe plaque psoriasis, tofacitinib significantly improved health-related quality of life, with a higher percentage of patients achieving a Dermatology Life Quality Index score of 1 or less compared to placebo at week 16, and these improvements were maintained through week 52.

Tofacitinib also led to rapid relief from itch, with improvements noticeable just one day after starting treatment, and a greater proportion of patients reported satisfaction with the treatment compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib improves pruritus and health-related quality of life up to 52 weeks: Results from 2 randomized phase III trials in patients with moderate to severe plaque psoriasis. Feldman, SR., Thaçi, D., Gooderham, M., et al.[2017]

Citations

1. otezlapro.com otezlapro.com/plaque-psoriasis/efficacy/

otezla® (apremilast) efficacy in plaque psoriasis Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of adult patients with moderate to severe plaque psoriasis treated with Otezla and in 5% ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40317400/

Efficacy and Safety of Apremilast Over 52 Weeks in ... A previous study showed that apremilast greatly improved quality of life, reduced itchiness, and decreased skin discomfort and pain as early as 16 weeks after ...

3. otezlapro.com otezlapro.com/plaque-psoriasis/efficacy/real-world/

Real-World PsO Data | Otezla® (apremilast) HCP Primary Endpoint: 22% of patients taking Otezla 30 mg BID (n=297) achieved an sPGA score of 0 (clear) or 1 (almost clear) and a ≥2-point reduction from baseline ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4517531/

Apremilast (Otezla): A New Oral Treatment for Adults With ... The 52-week results of the PALACE 1 trial demonstrated that in those patients who continued treatment with apremilast, treatment efficacy was maintained; ACR20 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03701763

NCT03701763 | Efficacy and Safety Study of Apremilast ... Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial.

6. otezlapro.com otezlapro.com/plaque-psoriasis/safety/

PsO Safety Profile | Otezla® (apremilast) HCP Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache.

7. otezlapro.com otezlapro.com/resource-center/video-hub/safety-data-videos/

Clinical Trial Safety Data - Video Resources - Otezla Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache.

8. otezla.com otezla.com/plaque-psoriasis/safety

Safety Information | Otezla® (apremilast) for PsO Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10266699/

Apremilast Long-Term Safety Up to 5 Years from 15 Pooled ... We analyzed longer-term safety and tolerability of apremilast 30 mg twice daily across three indications for up to 5 years, focusing on adverse events of ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/205437s014lbl.pdf

OTEZLA® (apremilast) tablets, for oral use - accessdata.fda.gov The safety of OTEZLA was assessed in 1426 subjects in three randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque ...