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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	Not Recruiting
Health condition(s) or Problem(s) studied	Plaque Psoriasis
Date of first enrollment	06/11/2023
Target sample size	693
Countries of recruitment	United States,Japan,Australia,Japan,Canada,Japan,China,Japan,Germany,Japan,Italy,Japan,Korea,Japan,Poland,Japan,Taiwan,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)	NCT06088043,2023-505841-22

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