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

Plaque Psoriasis Clinical Trial

— SAIL  

Official title:

Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04203693
• Other study ID #: NIS Study M-14745-43
• Status: Active, not recruiting
• Start date: October 30, 2019
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 331
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
• Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Austria	Investigator Site 1	Wien
Germany	Investigational site 5	Augsburg
Germany	Investigational site 10	Berlin
Germany	Investigational site 11	Berlin
Germany	Investigational site 13	Berlin
Germany	Investigational site 8	Erlangen
Germany	Investigational site 9	Greifswald
Germany	Investigational site 1	Hamburg
Germany	Investigational site 2	Hamburg
Germany	Investigational site 7	Kiel
Germany	Investigational site 3	Lübeck
Germany	Investigational site 6	München
Germany	Investigational site 12	Oberursel
Germany	Investigational site 4	Quedlinburg
Italy	Investigational site 6	Catania
Italy	Investigational site 7	Genova
Italy	Investigational site 3	Modena
Italy	Investigational site 4	Parma
Italy	Investigational site 1	Roma
Italy	Investigational site 2	Roma
Italy	Investigational site 5	Roma
Netherlands	Investigational site 1	Breda

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 48
Primary	Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 96
Primary	Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.	Baseline (Day 0) and Week 48
Primary	Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.	Baseline (Day 0) and Week 96
Primary	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 48	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Week 48
Primary	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	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Week 96
Primary	Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 48	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 48
Primary	Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 96	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 96
Primary	Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Week 48
Primary	Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Week 96
Primary	Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 48	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Baseline (Day 0) and Week 48
Primary	Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 96	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Baseline (Day 0) and Week 96
Primary	Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Week 48
Primary	Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Week 96
Primary	Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 48	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe).	Baseline (Day 0) and Week 48
Primary	Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 96	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body. PGA of psoriasis in general, at nail and scalp will be graded from 0 (none/clear) to 4 (severe).	Baseline (Day 0) and Week 96
Primary	Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 52
Primary	Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 100
Primary	Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.	Baseline (Week 0) and Week 52
Primary	Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.	Baseline (Week 0) and Week 100
Primary	Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 52	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Week 52
Primary	Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 100	PASI is used to assess the lesion severity and affected area due to psoriasis. Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Week 100
Primary	Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 52	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 52
Primary	Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 100	PASI is a combined assessment of lesion severity and affected area into a single score.	Week 100
Primary	Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Week 52
Primary	Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Week 100
Primary	Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 52	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Baseline and Week 52
Primary	Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 100	BSA is a numerical score used to measure the total area of the body affected by psoriasis.	Baseline and Week 100
Primary	Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 52	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Week 52
Primary	Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 100	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Week 100
Primary	Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 52	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Baseline (Day 0) and Week 52
Primary	Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 100	PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and scale averaged over the entire body.	Baseline (Day 0) and Week 100
Secondary	Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2	Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
Secondary	Change from Baseline in Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2	Dermatology Life Quality Index (DLQI) questionnaire is the most commonly used tool to assess the effect of skin diseases on a subject's quality of life. Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) is a newly introduced variation of the regular DLQI that adjusts the total score for the number of not relevant responses.	Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100
Secondary	Itch and Pain Visual Analogue Scales (VAS) Scores	Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS).	Baseline (Day 0) to Week 96/100
Secondary	Change from Baseline in Itch and Pain Visual Analogue Scales Scores	Itch and pain of the skin will be assessed by the participant on visual analogue scales (VAS).	Baseline (Day 0) to Week 96/100
Secondary	Number of participants who Used Concomitant Medications From Baseline at Week 48 and 96 for Cohort 1 and Week 52 and 100 for Cohort 2	Concomitant topical, photo- or systemic anti-psoriatic and non-psoriasis therapy will be assessed.	Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100
Secondary	Change from Baseline in Body Weight at End of study (EOS)/End of treatment (ET)	Change in the body weight measurement will be assessed.	Baseline (Day 0) and Week 96/100 (EOS)/ET
Secondary	Change from Baseline in Waist and hip Circumference at EOS/ET	Change in waist and hip circumference will be assessed.	Baseline (Day 0) and Week 96/100 (EOS)/ET
Secondary	Change from Baseline in Body Mass Index (BMI) at EOS/ET	Change in BMI will be assessed.	Baseline (Day 0) and Week 96/100 (EOS)/ET
Secondary	Change from Baseline in Blood Pressure at EOS/ET	Change in Blood Pressure will be assessed.	Baseline (Day 0) and Week 96/100 (EOS)/ET
Secondary	Change from Baseline in Food Intake up to EOS/ET	Participants will be asked to complete a simple questionnaire regarding their food intake.	Baseline (Day 0) to Week 96/100 (EOS)/ET
Secondary	Change from Baseline in Physical Activity up to EOS/ET	Participants will be asked to complete a simple questionnaire regarding their physical activity.	Baseline (Day 0) to Week 96/100 (EOS)/ET
Secondary	Change from baseline in Lipid Profiles up to EOS	Serum lipid will be assessed, if available	Baseline (Day 0) to Week 96/100 (EOS)
Secondary	Number of Participants Withdraw From the Study Overtime	Participants who discontinue treatment prior to the regular end of the observation period.	Baseline (Day 0) to Week 96/100 (EOS)
Secondary	Number of Participants who Underwent Dose Change up to EOS/ET	The number of participants who underwent dose change (100 mg or 200 mg).	Baseline (Day 0) to Week 96/100 (EOS)/ET
Secondary	Drug Survival up to EOS/ET	Drug survival is defined as the time from initiation of therapy to discontinuation.	Baseline (Day 0) to Week 96/100 (EOS)/ET
Secondary	Number of Participant's With Adherence to Treatment up to EOS/ET	Number of Participant's who adhere to the treatment will be assessed.	Baseline (Day 0) to Week 96/100 (EOS)/ET