Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

NCT04203693 | Completed Results FDA Drug

• 1 other identifier: NIS Study M-14745-43
• Study Type: observational
• Target: 331
• Locations: 6 countries
• Sites: 41

Brief Summary

The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.

Conditions

Plaque Psoriasis

Keywords

Ilumetri®; Tildrakizumab; Moderate to severe plaque psoriasis

Outcome Measures

Primary Outcomes (32)

• Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 48

  The PASI was calculated by assessing four body regions: head (10 percent \[%\] of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

  At Week 48

• Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 96

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

  At Week 96

• Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 48

  PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 48

• Cohort 1: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 96

  PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 96

• Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) Scores at Week 48

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

  At Week 48

• Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 96

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

  At Week 96

• Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 48

  PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

  At Week 48

• Cohort 1: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 96

  PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

  At Week 96

• Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

  At Week 48

• Cohort 1: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

  At Week 96

• Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 48

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 48 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

  Baseline (Day 0 of reSURFACE Studies), Week 48 (Current study)

• Cohort 1: Change From Baseline of reSURFACE Study in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 96

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline value of reSURFACE Studies was used to calculate change at Week 96 of current study. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

  Baseline (Day 0 of reSURFACE Studies), Week 96 (Current Study)

• Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

  At Week 48

• Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

  At Week 96

• Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 48

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 48 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

  Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 48 (Current Study)

• Cohort 1: Change From Baseline (reSURFACE Studies for General and Current Study for Nail and Scalp) in Physician's Global Assessment (PGA) Score at Week 96

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline value of reSURFACE Studies was used to calculate change for "General" at Week 96 of current study. For "Nail" and "Scalp", Baseline value of current study was used to calculate change. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration (also if participant participated in tildrakizumab \[reSURFACE\] clinical trials).

  Baseline (Day 0 of reSURFACE Studies for General and current study for Nail and Scalp), Week 96 (Current study)

• Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 52

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

  At Week 52

• Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) Scroe at Week 100

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes.

  At Week 100

• Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 52

• Cohort 2: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 100

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, the area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, the severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of all 3 severity parameters was then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). The range of the PASI was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 100

• Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 52

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

  At Week 52

• Cohort 2: Correlation Between Absolute Psoriasis Area and Severity Index (PASI) Scores and Dermatology Life Quality Index Adjusted for Not Relevant Responses (DLQI-R) at Week 100

  The PASI was calculated by assessing four body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). The range of the PASI scale was from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis), where higher score indicates severe outcomes. The DLQI questionnaire consisted of 10 questions. Each question was scored from 0 to 3, giving a total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), where higher score indicates severe impact on quality of life. The DLQI-R was a newly introduced variation of the regular DLQI that adjusted the total score for the number of not relevant responses and a valid scoring system for avoiding the bias of these not relevant responses of the questionnaire. Pearson correlation was performed for correlation analysis.

  At Week 100

• Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 52

  PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who have achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

  At Week 52

• Cohort 2: Percentage of Participants Who Maintained Psoriasis Area and Severity Index (PASI) 75, 90, and 100 Responses at Week 100

  PASI 75 and 90 defined as percentage of participants who achieved \>=75% and \>=90% reductions, respectively in their PASI score from baseline. PASI 100 defined as percentage of participants who achieved a complete resolution of all disease. PASI was calculated by assessing 4 body regions: head (10% of skin), arms (20%), trunk (30%), and legs (40%). For each region, area of skin affected was estimated and graded on a scale from 0 to 6, where 0 indicated no involved area and 6 indicated 90-100% of involved area. Within each area, severity was estimated by 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters measured on a scale of 0 to 4. Sum of all 3 severity parameters was then calculated for each section of skin, multiplied by area score for that area and multiplied by weight of respective sections (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs). PASI range was from 0 (no psoriasis) to 72 (most severe case).

  At Week 100

• Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

  At Week 52

• Cohort 2: Percentage of Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage.

  At Week 100

• Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 52

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 52

• Cohort 2: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Psoriasis at Week 100

  The BSA measures the total area of the body affected by psoriasis assessed by the study physician in terms of percentage. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 100

• Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

  At Week 52

• Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes.

  At Week 100

• Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 52

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 52

• Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail and Scalp) Scores at Week 100

  The PGA is a 5-point measure of psoriasis. The PGA of psoriasis of the whole body (general), scalp and nail were made on a 5-point scale ranged from 0 to 4, where 0 = none (clear); 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. The higher score indicates severe outcomes. Baseline defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab administration.

  Baseline (current study), Week 100

Secondary Outcomes (23)

• Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2

  Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100

• Change From Baseline in Absolute Dermatology Life Quality Index (DLQI) Score at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2

  Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100

• Absolute Dermatology Life Quality Index Score Adjusted for Not Relevant Responses (DLQI-R) at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2

  Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100

• Change From Baseline in Dermatology Life Quality Index Score Adjusted for Not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2

  Cohort 1: Baseline (current study), Week 48 and Week 96; Cohort 2: Baseline (current study), Week 52 and Week 100

• Itch and Pain Visual Analogue Scales (VAS) Scores at Week 96 for Cohort 1 and Week 100 for Cohort 2

  Cohort 1: At Week 96; Cohort 2: At Week 100

Study Arms (2)

Cohort 1: Tildrakizumab Treated Participants

Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies

Drug: Tildrakizumab

Cohort 2: Newly Tildrakizumab Prescribed Participants

Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study)

Drug: Tildrakizumab

Interventions

Tildrakizumab DRUG

The study physicians will choose the treatment independently of the enrolment in the study according to routine care.

Cohort 1: Tildrakizumab Treated Participants; Cohort 2: Newly Tildrakizumab Prescribed Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with moderate-to-severe chronic plaque psoriasis.

You may qualify if:

• Written informed consent form.
• Age \>= 18years.
• Moderate to severe chronic plaque psoriasis diagnosis.
• Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).

You may not qualify if:

• Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (41)

Investigator Site 1

Baden, Austria

Location

Investigator Site 2

Vienna, Austria

Location

Investigator Site 1

Brussels, Belgium

Location

Investigator Site 2

Charleroi, Belgium

Location

Investigator Site 3

Genk, Belgium

Location

Investigator Site 4

Ghent, Belgium

Location

Investigator Site 5

Herstal, Belgium

Location

Investigator Site 6

Jette, Belgium

Location

Investigator Site 7

Lede, Belgium

Location

Investigator Site 8

Leuven, Belgium

Location

Investigator Site 9

Mons, Belgium

Location

Investigational Site 1

Nice, France

Location

Investigator Site 2

Poitiers, France

Location

Investigational Site 1

Augsburg, Germany

Location

Investigational Site 2

Berlin, Germany

Location

Investigational Site 3

Bochum, Germany

Location

Investigational Site 10

Cologne, Germany

Location

Investigational Site 4

Erlangen, Germany

Location

Investigational Site 5

Greifswald, Germany

Location

Investigational Site 7

Halle, Germany

Location

Investigational Site 6

Hamburg, Germany

Location

Investigational Site 8

Kiel, Germany

Location

Investigational Site 9

Kiel, Germany

Location

Investigational Site 11

Lübeck, Germany

Location

Investigational Site 13

Merzig, Germany

Location

Investigational Site 12

München, Germany

Location

Investigational Site 14

Oberursel, Germany

Location

Investigational Site 15

Quedlinburg, Germany

Location

Investigational Site 1

Arezzo, Italy

Location

Investigational Site 2

Brescia, Italy

Location

Investigational Site 3

Catania, Italy

Location

Investigational Site 4

Florence, Italy

Location

Investigational Site 5

Genova, Italy

Location

Investigational Site 6

Lecce, Italy

Location

Investigational Site 7

Modena, Italy

Location

Investigational Site 10

Roma, Italy

Location

Investigational Site 11

Roma, Italy

Location

Investigational Site 8

Roma, Italy

Location

Investigational Site 9

Roma, Italy

Location

Investigational Site 12

Rozzano, Italy

Location

Investigational site 1

Breda, Netherlands

Location

MeSH Terms

Interventions

tildrakizumab

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A

gco@almirall.com

+34932913000

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 18, 2019
• Study Start: October 30, 2019
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Locations

IT (12); NL (1); DE (15); AU (2); BE (9); FR (2)