Back to resultsEfficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (TRANSITION)
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dimethyl fumarate (DMF) standard scheme
Dimethyl fumarate (DMF) simplified scheme
Tildrakizumab
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Dimethyl fumarate, Tildrakizumab, Moderate-to-severe plaque psoriasis, Chronic Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Provide signed written and dated informed consent given before any study related activity is performed
- Participants with at least 6 months history of chronic plaque psoriasis
- Participants diagnosed with moderate-to-severe plaque psoriasis at the Screening Visit
- Candidate for systemic treatment for plaque psoriasis at the Screening Visit
Exclusion Criteria:
- Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
- Other forms of psoriasis than chronic plaque-type
- Participants with drug-induced psoriasis at the Screening Visit
- Participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis
- Participants with history of hypersensitivity or allergy to the study drugs
- Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
- Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the Screening visit
- Active infectious disease at the Screening Visit
- Participants positive test for human immunodeficiency virus or any other immunosuppressive disease
- Previous exposure to fumarate-based drug or a biologic systemic treatment
- Live vaccination within 4 weeks prior to the Baseline Visit
- Participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
- Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
Sites / Locations
- Investigator Site 3
- Investigator Site 1
- Investigator Site 2
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Non-Germany: Dimethyl fumarate standard scheme
Germany: Dimethyl fumarate standard scheme
Germany: Dimethyl fumarate simplified scheme
Arm Description
Part 1: Participants will receive Dimethyl fumarate (DMF) standard scheme from baseline to Week 16. Part 2: Participants achieving a Psoriasis Area and Severity Index (PASI) 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Part 1: Participants will receive DMF standard scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Part 1: Participants will receive DMF simplified scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Outcomes
Primary Outcome Measures
Part 2: Percentage of Participants Achieving a Psoriasis Area Severity Index 75 (PASI 75) after Tildrakizumab Treatment at Week 40
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). PASI 75 response, is defined as having an improvement (reduction) of greater than or equal to (>=) 75% in PASI score compared to the baseline score.
Secondary Outcome Measures
Part 1 and Part 2: Percentage of Participants Achieving PASI 50, PASI 75, PASI 90 and PASI 100 (Only for Part 2) Responses
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). PASI 50, 75, 90 response, is defined as having an improvement (reduction) of greater than or equal to (>=) 50%, 75%, 90% and 100% respectively in PASI score compared to the baseline score.
Part 1 and Part 2: Percentage of Participants Achieving an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 5, 3 and 1
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Percentage of participants who will achieve an absolute PASI score <= 5, 3 and 1 at Week 8 and Week 16 will be reported.
Part 1 and Part 2: Absolute Psoriasis Area Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Part 1 and Part 2: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Absolute Body Surface Area (BSA) Score
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).
Part 1 and Part 2: Change from Baseline in Absolute Body Surface Area (BSA) Score
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Part 1 and Part 2: Percentage of Participants Achieving Scalp Physician Global Assessment (scPGA) Score of 0 or 1
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.
Part 1 and Part 2: Percentage of Participants Achieving Palmoplantar Physician's Global Assessment (PPPGA) Score of 0 or 1
The PPPGA score is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed.
Part 1 and Part 2: Absolute Physician Global Assessment (PGA) Score
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Part 1 and Part 2: Absolute Scalp Physician Global Assessment (scPGA) Score
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.
Part 1 and Part 2: Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
The PPPGA score is used to assess the average severity of severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed.
Part 1 and Part 2: Change from Baseline in Absolute Physician Global Assessment (PGA) Score
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
The PPPGA score is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Percentage of Participants Achieving Dermatology Quality of Life Index (DLQI) Score of 0 or 1
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Part 1 and Part 2: Absolute Dermatology Quality of Life Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Part 1 and Part 2: Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Absolute Skindex-16 Score
Skindex is the dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100.
Part 1 and Part 2: Change from Baseline in Absolute Skindex-16 Score
Skindex is the best dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Absolute Pruritus-Visual Analogue Scale (VAS) Score
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm).
Part 1 and Part 2: Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 1 and Part 2: Absolute Medical Outcomes Study (MOS) Score
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name.
Part 1 and Part 2: Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Part 2: Percent Change from Baseline in Absolute Psoriasis Area Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Physician Global Assessment (PGA) Score
PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
The scPGA scores is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
PPPGA Scores is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Skindex-16 Score
Skindex is the dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm). Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Percent Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An Adverse event (AE) is defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE can therefore be any unfavourable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward will be counted as TEAE.
Percentage of Participants Withdrawing from Trial
Number of Participants with Treatment Compliance
Percentage of Participants Using Topical Corticosteroids (TCS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263610
Brief Title
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
Acronym
TRANSITION
Official Title
An Open-Label, Randomised, Phase IV Study, to Assess the Efficacy and Safety of Tildrakizumab in Patients With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (TRANSITION)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16. The study consists of two parts. Part 1 will include the first 16 weeks of the Treatment Period and Part 2 will include the last 24 weeks of the Treatment Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Dimethyl fumarate, Tildrakizumab, Moderate-to-severe plaque psoriasis, Chronic Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Germany: Dimethyl fumarate standard scheme
Arm Type
Experimental
Arm Description
Part 1: Participants will receive Dimethyl fumarate (DMF) standard scheme from baseline to Week 16.
Part 2: Participants achieving a Psoriasis Area and Severity Index (PASI) 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Arm Title
Germany: Dimethyl fumarate standard scheme
Arm Type
Experimental
Arm Description
Part 1: Participants will receive DMF standard scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Arm Title
Germany: Dimethyl fumarate simplified scheme
Arm Type
Experimental
Arm Description
Part 1: Participants will receive DMF simplified scheme from Baseline to Week 16.
Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate (DMF) standard scheme
Other Intervention Name(s)
Skilarence®
Intervention Description
Participants will receive DMF gastro-resistant tablet orally from baseline to Week 16, at a dose of 30 milligrams (mg) once daily, twice daily, thrice daily in Week 1, Week 2, Week 3 respectively, 120 mg only once in Week 4. Participants will increase DMF dose by 120 mg tablet per week for the subsequent 5 weeks. Participants achieving Psoriasis area and severity Index (PASI) 50-75 (partial responder) or 75 (responder) will continue the DMF treatment until Week 40. The maximum daily dose taken by a participant will be 720 mg.
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate (DMF) simplified scheme
Other Intervention Name(s)
Skilarence®
Intervention Description
Participants will receive DMF gastro-resistant tablet orally at a dose of 60, 120, 180, 240, 360 mg daily in Week 1, Week 2, Week 3, Week 4, Week 5 respectively, and 480 mg daily from Week 6 to Week 8. If a PASI is greater than or equal to (>=) 30% at Week 8, no dose increase will be done and if PASI is less than (<) 30% at Week 8, participants will receive 600 mg daily in Week 9 and 720 mg from the Week 10 onwards.
Intervention Type
Drug
Intervention Name(s)
Tildrakizumab
Other Intervention Name(s)
Ilumetri®
Intervention Description
Participants who achieve PASI less than (<) 50 (non-responders) at Week 16 will receive Tildrakizumab subcutaneous injection at a dose of either 100 or 200 mg [(as per the Summary of Product Characteristics (SmPC)] at Weeks 16, 20 and 32 up to Week 40.
Primary Outcome Measure Information:
Title
Part 2: Percentage of Participants Achieving a Psoriasis Area Severity Index 75 (PASI 75) after Tildrakizumab Treatment at Week 40
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). PASI 75 response, is defined as having an improvement (reduction) of greater than or equal to (>=) 75% in PASI score compared to the baseline score.
Time Frame
Week 40
Secondary Outcome Measure Information:
Title
Part 1 and Part 2: Percentage of Participants Achieving PASI 50, PASI 75, PASI 90 and PASI 100 (Only for Part 2) Responses
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). PASI 50, 75, 90 response, is defined as having an improvement (reduction) of greater than or equal to (>=) 50%, 75%, 90% and 100% respectively in PASI score compared to the baseline score.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Percentage of Participants Achieving an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 5, 3 and 1
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Percentage of participants who will achieve an absolute PASI score <= 5, 3 and 1 at Week 8 and Week 16 will be reported.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Psoriasis Area Severity Index (PASI) Score
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Body Surface Area (BSA) Score
Description
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Body Surface Area (BSA) Score
Description
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1
Description
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Percentage of Participants Achieving Scalp Physician Global Assessment (scPGA) Score of 0 or 1
Description
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Percentage of Participants Achieving Palmoplantar Physician's Global Assessment (PPPGA) Score of 0 or 1
Description
The PPPGA score is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Physician Global Assessment (PGA) Score
Description
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Scalp Physician Global Assessment (scPGA) Score
Description
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
Description
The PPPGA score is used to assess the average severity of severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed.
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Physician Global Assessment (PGA) Score
Description
The PGA score is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
Description
The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
Description
The PPPGA score is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Percentage of Participants Achieving Dermatology Quality of Life Index (DLQI) Score of 0 or 1
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
Title
Part 1 and Part 2: Absolute Dermatology Quality of Life Index (DLQI) Score
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40
Title
Part 1 and Part 2: Absolute Skindex-16 Score
Description
Skindex is the dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100.
Time Frame
Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Skindex-16 Score
Description
Skindex is the best dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40
Title
Part 1 and Part 2: Absolute Pruritus-Visual Analogue Scale (VAS) Score
Description
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm).
Time Frame
Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
Description
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm). Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, DMF: Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 1 and Part 2: Absolute Medical Outcomes Study (MOS) Score
Description
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name.
Time Frame
Part 1: Week 16; Part 2: Week 40
Title
Part 1 and Part 2: Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
Description
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name. Baseline value is defined as values collected at Week 1 of Part 1 of the study. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Part 1: Baseline, Week 16; Part 2: Baseline, Week 40
Title
Part 2: Percent Change from Baseline in Absolute Psoriasis Area Severity Index (PASI) Score
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Physician Global Assessment (PGA) Score
Description
PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
Description
The scPGA scores is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
Description
PPPGA Scores is used to assess the average severity of psoriasis lesions on hands and/or feet. The PPPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe psoriasis lesions on hands and/or feet. Only in participants with palmar or plantar involvement the PPPGA assessment will be performed. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
Baseline, Weeks 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Skindex-16 Score
Description
Skindex is the dermatological instruments to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
Baseline, Weeks 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
Description
The pruritus-VAS is used to assess the pruritus by ticking the scale, which describes pruritus the best. The pruritus-VAS is a single-item continuous scale comprised of a 10 centimeter (cm) [(100 millimeter (mm)] horizontal/vertical line anchored by two verbal descriptors, one for each symptom extreme. For pruritus intensity, the scale is anchored by "no pruritus" (score of 0) and "worst imaginable pruritus" (score of 100 mm). Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
Title
Part 2: Percent Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
Description
The MOS score questionnaire consists of 12 items leading to 6 subscales or domains: sleep disturbance, sleep adequacy, daytime sleepiness, 'supposed or known' snoring, being awakened by shortness of breath or by a headache, and quantity of sleep. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS score reflects more of the attribute indicated by the subscale name. Baseline value is defined as values collected at Week 1 of Part 1 of the study.
Time Frame
Baseline, Week 40
Title
Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Description
An Adverse event (AE) is defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE can therefore be any unfavourable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward will be counted as TEAE.
Time Frame
From start of study drug administration up to Week 49
Title
Percentage of Participants Withdrawing from Trial
Time Frame
From start of study drug administration up to Week 49
Title
Number of Participants with Treatment Compliance
Time Frame
From start of study drug administration up to Week 49
Title
Percentage of Participants Using Topical Corticosteroids (TCS)
Time Frame
Part 1: Baseline up to Week 14; Part 2: Week 20 to Week 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide signed written and dated informed consent given before any study related activity is performed
Participants with at least 6 months history of chronic plaque psoriasis
Participants diagnosed with moderate-to-severe plaque psoriasis at the Screening Visit
Candidate for systemic treatment for plaque psoriasis at the Screening Visit
Exclusion Criteria:
Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
Other forms of psoriasis than chronic plaque-type
Participants with drug-induced psoriasis at the Screening Visit
Participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis
Participants with history of hypersensitivity or allergy to the study drugs
Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the Screening visit
Active infectious disease at the Screening Visit
Participants positive test for human immunodeficiency virus or any other immunosuppressive disease
Previous exposure to fumarate-based drug or a biologic systemic treatment
Live vaccination within 4 weeks prior to the Baseline Visit
Participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Almirall, SAS
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 3
City
Augsburg
Country
Germany
Facility Name
Investigator Site 1
City
Bristol
Country
United Kingdom
Facility Name
Investigator Site 2
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
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