What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis include TNF-alpha inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, and oral agents like apremilast and dimethyl fumarate. TNF-alpha inhibitors can lead to an increased risk of infections, injection site reactions, and potential cardiovascular benefits. IL-17 inhibitors may cause inflammatory bowel disease events and increased risk of infections. IL-12/23 inhibitors are associated with serious infections and potential cardiovascular events. Apremilast commonly causes gastrointestinal issues, headaches, and weight loss. Dimethyl fumarate can lead to gastrointestinal symptoms, flushing, and lymphopenia. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of plaque psoriasis, focusing on different mechanisms of action. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, is one such treatment. Ustekinumab, an IL-12/23 inhibitor, has also been approved and shown to be effective in real-world practice. Other biologics, such as TNF-alpha inhibitors (e.g., infliximab) and IL-17 inhibitors (e.g., secukinumab and ixekizumab), have demonstrated efficacy in reducing psoriasis symptoms. These treatments have been validated through rigorous clinical trials and postmarketing surveillance studies, ensuring their safety and effectiveness for patients with moderate-to-severe plaque psoriasis.

What other types of research exist?

Promising, novel alternatives to TAK-279 for plaque psoriasis patients include: 1) Apremilast, an approved treatment for plaque psoriasis. 2) Ustekinumab, targeting interleukin-12 and interleukin-23, with demonstrated efficacy in multiple studies. 3) Secukinumab, targeting interleukin-17A, effective in both plaque psoriasis and psoriatic arthritis. 4) Ixekizumab, another IL-17A inhibitor, effective in refractory cases. 5) Brodalumab, targeting the IL-17 receptor, showing efficacy in recalcitrant cases. These alternatives offer various mechanisms of action and have shown positive outcomes in clinical settings.

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TAK-279 for Plaque Psoriasis

Verified Trial

Phase 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You have been diagnosed with Plaque Psoriasis

Plaque psoriasis for at least 6 months

Timeline

Screening 14 days

Treatment 60 weeks

Follow Up 4 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with medications like TAK-279 and Apremilast may include digestive issues, headaches, potential risk of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 14 days1 visit

Treatment ~ 60 weeks15 visits

Follow Up ~ 4 weeks1 visit

Screening ~ 14 days

Treatment ~ 60 weeks

Follow Up ~4 weeks

This trial's timeline: 14 days for screening, 60 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo

Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo

Secondary study objectives

Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast

Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo

Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo

+48 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309

30%

diarrhea

30%

nausea

25%

headache

15%

abdominal cramping

15%

upset stomach, unspecified

10%

heartburn

viral gastroenteritis

cyst left inner thigh

abscess right hand

right flank pain

irritability

leg cramps

upper respiratory infection

otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Apremilast

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: TAK-279Experimental Treatment1 Intervention

Group II: ApremilastActive Control1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-279

2023

Completed Phase 1

~390

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for plaque psoriasis include TNF-alpha inhibitors, IL-12/23 inhibitors, and small molecule inhibitors like tofacitinib. TNF-alpha inhibitors work by blocking the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, thereby reducing inflammation and plaque formation. IL-12/23 inhibitors target interleukins 12 and 23, which are key cytokines in the inflammatory pathway of psoriasis, helping to reduce the immune response that leads to plaque formation. Small molecule inhibitors like tofacitinib target the Jak/Stat signaling pathway, which is involved in the immune response and inflammation. These treatments are crucial for patients with plaque psoriasis as they help manage the chronic inflammation and reduce the severity of skin lesions, improving quality of life.

Epidermal mTORC1 Signaling Contributes to the Pathogenesis of Psoriasis and Could Serve as a Therapeutic Target.Potential antipsoriatic effect of chondroitin sulfate through inhibition of NF-κB and STAT3 in human keratinocytes.