TAK-279-3001

Recruitment Complete

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

Clinicaltrials.gov

EU CTIS

#2023-505841-22-00

jRCT

#jRCT2031230583

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 61 weeks.

Interventional Phase 3 clinical trial.

What medical conditions were being studied?

Plaque Psoriasis

What was the clinical trial testing?

Placebo, TAK-279, Apremilast

How many participants were enrolled?

693

Were placebos part of the clinical trial?

Yes

When was the clinical trial conducted?

Nov 2023 - Apr 2026

How long was participation in the clinical trial?

Participants will stay in the study for up to 56 weeks and will receive treatment for up to 52 weeks (1 year).

Sexes

All

Age

18+ Years

Healthy volunteers?

Must be men and women of 18 years and older.

Must have a diagnosis of moderate-to-severe plaque psoriasis which hasn’t changed for at least 6 months.

Must be a candidate for light therapy (phototherapy) or therapy that treats the whole body (systemic therapy).

Cannot have a type of psoriasis that is not plaque psoriasis

Cannot have previously taken TAK-279, deucravacitinib (a similar medicine), or apremilast

Cannot have had a recent infection or have a history of certain infections

Primary outcome measures

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 [Time Frame: Baseline, Week 16]

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 [Time Frame: Baseline, Week 16]

Secondary outcome measures

Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline, Week 16]

Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Week 16]

Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Week 16]

Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score >=2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Week 16]

Percentage of Participants with a Baseline Psoriasis Symptoms and Signs Diary (PSSD) >=1 who Achieve Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Week 16]

Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants with Nail Involvement at Baseline Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Change from Baseline in the EuroQoL 5-Dimension 5-level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Baseline and Week 16]

Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo [Time Frame: Week 16]

Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Baseline and Week 16]

Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline and Week 24]

Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Baseline and Week 16]

Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants with a Baseline DLQI Score >=2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast [Time Frame: Week 16]

Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline and Week 24]

Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Percentage of Participants with a Baseline DLQI Score >=2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast [Time Frame: Week 24]

Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 16 and 24]

Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast [Time Frame: Baseline, Weeks 24, 40 and 52]

Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast [Time Frame: Weeks 24, 40 and 52]

Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast [Time Frame: Weeks 24, 40 and 52]

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) [Time Frame: Up to Week 56]

Number of Participants with Clinically Significant Vital Signs [Time Frame: Up to Week 56]

Number of Participants with Clinically Significant Laboratory Values [Time Frame: Up to Week 56]

Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings [Time Frame: Up to Week 56]

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

About this clinical trial

At a glance