TAK-279 for Plaque Psoriasis

Recruiting at 134 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

693 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TAK-279 to see if it can help people with moderate to severe plaque psoriasis. The goal is to find out if TAK-279 can reduce the skin problems better than other available treatments.

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.

What data supports the effectiveness of the drug TAK-279 for treating plaque psoriasis?

Research on similar drugs, like deucravacitinib, a TYK2 inhibitor, shows that these types of drugs can effectively treat moderate to severe plaque psoriasis by targeting specific immune pathways, which helps reduce symptoms and improve quality of life. ^{1 2 3 4 5}

What safety data exists for TAK-279 (Zasocitinib) in humans?

TAK-279, also known as Zasocitinib, is a TYK2 inhibitor being studied for its safety in treating conditions like psoriasis. While specific safety data for TAK-279 is not detailed, similar TYK2 inhibitors have shown a low risk of off-target effects, suggesting a favorable safety profile in clinical trials for psoriasis. ^{1 3 5 6 7}

What makes the drug TAK-279 unique for treating plaque psoriasis?

TAK-279 is a small molecule TYK2 inhibitor, which is a novel approach for treating plaque psoriasis by targeting a specific pathway involved in the immune response, potentially offering a different mechanism of action compared to existing treatments like Apremilast. ^{8 9 10 11 12}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. [2021]

2. United States 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. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib in the treatment of psoriasis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tyrosine kinase 2 inhibitor deucravacitinib in the treatment of plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

TYK 2 inhibitors for the treatment of dermatologic conditions: the evolution of JAK inhibitors. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dermatological adverse events from BRAF inhibitors: a growing problem. [2021]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Appearance of New Vemurafenib-associated Melanocytic Nevi on Normal-appearing Skin: Case Series and a Review of Changing or New Pigmented Lesions in Patients with Metastatic Malignant Melanoma After Initiating Treatment with Vemurafenib. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Role of the MEK inhibitor trametinib in the treatment of metastatic melanoma. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Activity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trial. [2021]