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

Plaque psoriasis for at least 6 months

Moderate to severe disease

Must not have

Prior exposure to TAK-279 or active comparator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 24, 40 and 52

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 goal is to find out if TAK-279 can reduce the skin problems better than other available treatments.

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 or the active comparator.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions similar to those seen with other medications for psoriasis such as stomach issues, headaches, potential liver changes, and increased risk of infection. The exact side effects of TAK-279 are being studied.

Eligibility Criteria

Inclusion Criteria

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

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I have had plaque psoriasis for at least 6 months.

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My condition is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 24, 40 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 24, 40 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24, 40 and 52 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 (PASI-75 Response) 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

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