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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04203693
Other study ID # NIS Study M-14745-43
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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®.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
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