TAK-279 for Plaque Psoriasis

Recruiting at134 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Takeda

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

Treatment Details

Interventions

• Apremilast (Other)
• Placebo (Other)
• TAK-279 (Other)

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 Canada, Japan for the following indications:

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