Clinical trial

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Adult Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Name

TAK-279-PsO-3005

Description

The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279. 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 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times.

Trial arms

Trial start

2024-03-19

Estimated PCD

2025-06-30

Trial end

2026-03-27

Status

Recruiting

Phase

Early phase I

Treatment

TAK-279

Specified drug on specified days.

Arms:

TAK-279 for Erythrodermic Psoriasis, TAK-279 for Generalized Pustular Psoriasis

Size

Primary endpoint

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

Baseline, Week 16

Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16

Baseline, Week 16

Eligibility criteria

Inclusion Criteria: 1. A diagnosis of GPP or EP prior to the screening visit. 2. Candidate for phototherapy or systemic therapy. Exclusion Criteria: 1. Other forms of psoriasis. 2. History of recent infection. 3. Prior exposure to TAK-279. Other protocol defined inclusion/exclusion criteria apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-31

1 organization

1 product

2 indications

Organization

Takeda

Product

TAK-279

Indication

Generalized Pustular Psoriasis

Indication

Psoriasis