TAK-279 for Plaque Psoriasis

No longer recruiting at 246 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: Unknown

Duration: 60 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAK-279 (a small molecule TYK2 inhibitor) to evaluate its effectiveness for people with moderate-to-severe plaque psoriasis, a condition causing red, scaly skin patches. Participants will be divided into groups to receive either TAK-279, an existing treatment called apremilast, or a placebo (a harmless pill with no active drug). The goal is to compare how TAK-279 reduces these skin plaques compared to the other options. This trial suits someone who has had plaque psoriasis for at least six months and is considering treatments like phototherapy or systemic therapy. 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 option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop 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?

In earlier studies, TAK-279, also known as zasocitinib, showed promising safety results for treating moderate-to-severe plaque psoriasis. Research suggests that this treatment is generally well-tolerated. Reported side effects were mild and included common issues like headaches and mild stomach problems.

Apremilast, a treatment already approved for psoriasis, has a well-known safety record. The most common side effects include diarrhea, nausea, and headaches. These are usually mild, but some people may experience more severe stomach issues, especially when starting the treatment.

Both treatments appear relatively safe, with TAK-279 having a similar safety profile to existing treatments like apremilast. However, as with any medication, individual experiences may vary, and discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

TAK-279 is unique because it targets plaque psoriasis with a different mechanism of action compared to current treatments, which often focus on reducing inflammation. Unlike those standard options, TAK-279 may work by directly modulating the immune response, potentially offering a more precise approach to managing the condition. Researchers are excited about TAK-279 because it could provide faster relief and longer-lasting results for patients, making it a promising alternative to existing therapies.

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

Research has shown that TAK-279, also known as Zasocitinib, may effectively treat plaque psoriasis. In studies, many patients experienced at least a 75% improvement in their PASI score, a measure of psoriasis severity. This indicates that TAK-279 can significantly reduce skin plaques. Participants in this trial may receive TAK-279 as part of the experimental arm.

Apremilast, an already approved treatment, is another option in this trial and has also proven effective for plaque psoriasis. Specifically, studies found that about 22% of patients had clearer skin after four months, compared to 4% who took a placebo. Both treatments in this trial have demonstrated their ability to help manage the symptoms of 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.

Inclusion Criteria

You have been diagnosed with Plaque Psoriasis

Would you say that your plaque psoriasis affects more than 15 FULL palmprints' worth of your skin? (Add fractional palmprints as needed, e.g. 0.5 on your right arm, 1.5 on your left leg...)

Would you say that your plaque psoriasis affects more than 10 FULL palmprints' worth of your skin?

Exclusion Criteria

You have been diagnosed with Pustular Psoriasis

I have a type of psoriasis.

I have previously been treated with TAK-279 or a similar medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive the study medication (TAK-279, apremilast, or placebo) for up to 60 weeks

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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 existing drug called Apremilast and a placebo. Participants will randomly receive one of these treatments over the course of up to 69 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 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]

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 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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12126424/

Efficacy and Safety of Apremilast Over 52 Weeks in ... Apremilast was safe and effective through week 52 in European patients with chronic plaque psoriasis in at least one high-impact area, limited ...

3. 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.

4. otezla.com otezla.com/plaque-psoriasis/results

Plaque Psoriasis Before and After Results In a study of mild to moderate plaque psoriasis, 22% of people taking Otezla achieved clearer skin after 4 months compared to 4% on placebo. ~6x more people ...

5. amgen.com amgen.com/newsroom/press-releases/2021/04/otezla-apremilast-significantly-improved-measures-of-disease-severity-in-adults-with-mildtomoderate-plaque-psoriasis

OTEZLA® (apremilast) Significantly Improved Measures Of ... The ADVANCE findings demonstrated that oral apremilast significantly improved clinical measures of disease severity, such as Body Surface Area and scalp ...

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 ...