Clinical trial NCT04339595: Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis
Official title: A Phase IV Interventional Study to Assess the Disease-Modifying Effect of Long-Term Treatment With Tildrakizumab in Adult Patients With Moderate-To-Severe Plaque Psoriasis (MODIFY)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Human Antibody
Interleukin (IL) -23p19
Tildrakizumab
Moderate-To-Severe Plaque Psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the psoriasis disease control over time in participants who had received Tildrakizumab for at least the last 5 years and have discontinued it and to describe blood and skin inflammatory biomarkers and its correlation disease relapse.


Eligibility criteria: Inclusion Criteria:

* Participants provide signed written informed consent prior to perform any study-related activity
* Participants has completed the long-term extension of the reSURFACE 2 study

Exclusion Criteria:

* Participants unable to comply with the requirements of the study
* Participants who in the opinion of the investigator should not participate in the study

Primary outcomes:
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Baseline
timeFrame: Baseline
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 12
timeFrame: Week 12
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 24
timeFrame: Week 24
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 36
timeFrame: Week 36
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 48
timeFrame: Week 48
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 60
timeFrame: Week 60
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 72
timeFrame: Week 72
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 84
timeFrame: Week 84
measure: Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 96/End of Study (EOS)
timeFrame: Week 96/End of study (EOS)
measure: Number of Participants with Presence of Skin Inflammatory Biomarkers at Baseline
timeFrame: Baseline
measure: Number of Participants with Presence of Skin Inflammatory Biomarkers at Week 48 or End of Study (EOS)
timeFrame: up to Week 48
measure: Percentage of Participants Who Experienced Psoriasis Relapse
timeFrame: Baseline up to Week 96/ End of study (EOS)
Secondary outcomes:
measure: Time to Psoriasis Relapse
timeFrame: Baseline up to Week 96(EOS)
measure: Absolute Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Body Surface Area (BSA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Body Surface Area (BSA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Dermatology Quality of Life Index (DLQI) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Physician's Global Assessment (PGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Physician Global Assessment (PGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Nail Physician Global Assessment (nPGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Nail Physician Global Assessment (nPGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Scalp Physician Global Assessment (scPGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Absolute Pain-Numeric Rating Scale (Pain-NRS) and Pruritus-Numeric Rating Scale (Pruritus-NRS) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Change from Baseline in Absolute Pain- and Pruritus-Numeric Rating Scale (NRS) Scores
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 96/ End of study (EOS)
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination
timeFrame: Baseline up to Week 96/ End of study (EOS)
measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
timeFrame: Baseline up to Week 96/ End of study (EOS)
measure: Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters
timeFrame: Baseline up to Week 96/ End of study (EOS)
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Site 0001
city: Wroclaw
country: Poland
facility: Site 0002
city: Łódź
country: Poland
facility: Site 0003
Study officials:
affiliation: Almirall, SAS
name: Study Director
role: STUDY_DIRECTOR
References: