TAK-279 for Psoriasis

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of the drug administration up to week 56 (part a) and week 160 (part b)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to study the side effects and tolerance of TAK-279 in people with moderate-to-severe plaque psoriasis. Participants will be given TAK-279 and will continue treatment based on

Who is the study for?

This trial is for adults over 18 with chronic plaque psoriasis for at least 6 months, covering more than 10% of their body. They must be stable, without significant changes in their condition recently and be candidates for phototherapy or systemic therapy. Participants need to understand the study procedures and agree to follow them.

What is being tested?

The trial tests TAK-279's safety and effectiveness in those with moderate-to-severe plaque psoriasis. It involves up to 217 weeks of treatment including a screening period, an initial treatment phase (Part A), an optional extended phase (Part B), and a follow-up.

What are the potential side effects?

While specific side effects are not listed here, participants will monitor how well they tolerate TAK-279 throughout the study duration, focusing on any adverse reactions that may arise from its use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of the drug administration up to week 56 (part a) and week 160 (part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of the drug administration up to week 56 (part a) and week 160 (part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of the drug administration up to week 56 (part a) and week 160 (part b) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)

Secondary study objectives

Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score

Part A and B: Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a >=2-point Decrease from Baseline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279Experimental Treatment1 Intervention

Part A: Participants will receive TAK-279, oral tablet once daily (QD) for up to 52 weeks. Part B: Participants who completed the treatment period of parent studies (TAK-279-3001 \[NCT06088043\] or TAK-279-3002 \[NCT06108544\]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-279

2023

Completed Phase 1

~390

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