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JRCT ID: jRCT2031230583

Registered date:22/01/2024

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Plaque Psoriasis
Date of first enrollment	06/11/2023
Target sample size	600
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	-TAK-279 -Placebo -Apremilast

TO Original Data: JRCT

Outcome(s)

Primary Outcome	1.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 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. 2.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 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Secondary Outcome	1.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 2.Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 3.Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 4.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 5.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 6.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 7.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 8.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 9.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 10.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 11.Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo Time Frame: Baseline and Week 16 12.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 13.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 14.Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 15.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 16.Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 17.Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 18.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 19.Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 20.Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 21.Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Baseline and Week 16 22.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 23.Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 24.Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 25.Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 26.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 27.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 28.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 29.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 30.Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Time Frame: Baseline, Weeks 16 and 24 31.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 32.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 33.Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 34.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 35.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 36.Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Time Frame: Baseline, Weeks 16 and 24 37.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 38.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 39.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 40.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 41.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 42.Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Time Frame: Weeks 24, 40 and 52 43.Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Time Frame: Weeks 24, 40 and 52 44.Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) Time Frame: Up to Week 56 45.Number of Participants with Clinically Significant Vital Signs Time Frame: Up to Week 56 46.Number of Participants with Clinically Significant Laboratory Values Time Frame: Up to Week 56 47.Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings Time Frame: Up to Week 56

Primary Outcome

1.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 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. 2.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 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.

Secondary Outcome

1.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 2.Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 3.Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 4.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 5.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 6.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 7.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 8.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 9.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 10.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 11.Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo Time Frame: Baseline and Week 16 12.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 13.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 14.Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo Time Frame: Week 16 15.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 16.Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 17.Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 18.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 19.Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 20.Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 21.Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Baseline and Week 16 22.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 23.Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 24.Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 25.Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast Time Frame: Week 16 26.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 27.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 28.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 29.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 30.Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Time Frame: Baseline, Weeks 16 and 24 31.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 32.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 33.Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast Time Frame: Week 24 34.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 35.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 36.Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Time Frame: Baseline, Weeks 16 and 24 37.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 38.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 39.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 40.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 41.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 42.Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Time Frame: Weeks 24, 40 and 52 43.Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Time Frame: Weeks 24, 40 and 52 44.Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) Time Frame: Up to Week 56 45.Number of Participants with Clinically Significant Vital Signs Time Frame: Up to Week 56 46.Number of Participants with Clinically Significant Laboratory Values Time Frame: Up to Week 56 47.Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings Time Frame: Up to Week 56

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Plaque psoriasis for at least 6 months. 2.Moderate to severe disease. 3.Candidate for phototherapy or systemic therapy. Other protocol defined inclusion criteria apply.
Exclude criteria	1.Other forms of psoriasis. 2.History of recent infection. 3.Prior exposure to TAK-279 or active comparator. Other protocol defined exclusion criteria apply.

Related Information

Primary Sponsor	Shikamura Mitsuhiro
Secondary Sponsor
Source(s) of Monetary Support
Secondary ID(s)	NCT06088043

Contact

Public contact
Name	Contact for Clinical Trial Information
Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone	+81-6-6204-2111
E-mail	smb.Japanclinicalstudydisclosure@takeda.com
Affiliation	Takeda Pharmaceutical Company Limited
Scientific contact
Name	Mitsuhiro Shikamura
Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone	+81-6-6204-2111
E-mail	smb.Japanclinicalstudydisclosure@takeda.com
Affiliation	Takeda Pharmaceutical Company Limited

TO Original Data: JRCT