A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-279 — DRUG
  TAK-279 oral tablet

Study Details

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.

Key Dates

Start date

Sep 4, 2024

Status verified

May 2026

Primary completion

Aug 5, 2029

Completion

Aug 5, 2029

Study Design

Enrollment

2,099 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279
  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 \[NCT06088043\], TAK-279-3002 \[NCT06108544\], or TAK-279-PsO-3004 \[NCT06973291\]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.

Primary Outcome Measure

Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) [ Time Frame: From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B) ]

Locations (74)

Find similar trials in Birmingham, AL

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