TAK-279 for Plaque Psoriasis

Recruiting at 218 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

1108 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 study will compare TAK-279 to an existing treatment called apremilast, which is approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. The goal is to find out if TAK-279 can better reduce the skin problems associated with this condition.

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.

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 (also known as NDI-034858 or Zasocitinib) in humans?

While specific safety data for TAK-279 is not provided, similar TYK2 inhibitors like deucravacitinib and brepocitinib have been studied for safety in treating psoriasis. These studies suggest that selective TYK2 inhibitors generally have a low risk of off-target effects, meaning they are less likely to cause unwanted side effects compared to less selective treatments. ^{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.

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

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

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

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 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, 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. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib in the treatment of psoriasis. [2023]

2. 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]

3. 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]

4. 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]

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

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

11. 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]

12. Australia pubmed.ncbi.nlm.nih.gov

Acneiform eruptions: a common cutaneous toxicity of the MEK inhibitor trametinib. [2016]