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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Almirall, S.A.
- Enrollment
- 47
- Locations
- 3
- Primary Endpoint
- Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 48
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tildrakizumab
Intervention: Tildrakizumab (Biological)
Outcomes
Primary Outcomes
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 48
Time Frame: Week 48
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 60
Time Frame: Week 60
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 12
Time Frame: Week 12
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Skin Inflammatory Biomarkers at Week 48 or End of Study (EOS)
Time Frame: up to Week 48
Inflammatory biomarkers will be assessed using a small piece of 4 millimeter (mm) of skin biopsy sample collected at Week 48 or until the date of initiation of any systemic therapy including phototherapy whichever comes first (EOS) (stored in RNAlater solution).
Percentage of Participants Who Experienced Psoriasis Relapse
Time Frame: Baseline up to Week 96/ End of study (EOS)
Psoriasis Area and Severity Index (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). Relapse is defined using the following thresholds: PASI greater than (\>) 3 (participants who had a PASI lesser than or equal to \[\<=\] 3 at baseline); PASI \> 5 (participants who had a PASI \<= 5 at baseline); DLQI \> 5 (participants who had a DLQI \<= 5 at baseline); Initiation of any topical drug/medication for psoriasis; Initiation of any systemic therapy for psoriasis (biologic or non-biologic).
Number of Participants with Presence of Blood Inflammatory Biomarkers at Baseline
Time Frame: Baseline
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 24
Time Frame: Week 24
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 36
Time Frame: Week 36
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 72
Time Frame: Week 72
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 84
Time Frame: Week 84
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 96/End of Study (EOS)
Time Frame: Week 96/End of study (EOS)
Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.
Number of Participants with Presence of Skin Inflammatory Biomarkers at Baseline
Time Frame: Baseline
Inflammatory biomarkers will be assessed using a small piece of 4 millimeter (mm) of skin biopsy sample collected at Baseline (stored in RNAlater solution).
Secondary Outcomes
- Time to Psoriasis Relapse(Baseline up to Week 96(EOS))
- Absolute Psoriasis Area and Severity Index (PASI) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Body Surface Area (BSA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Body Surface Area (BSA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Dermatology Quality of Life Index (DLQI) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Physician's Global Assessment (PGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Physician Global Assessment (PGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Nail Physician Global Assessment (nPGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Nail Physician Global Assessment (nPGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Absolute Scalp Physician Global Assessment (scPGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Number of Participants with Clinically Significant Abnormalities in Physical Examination(Baseline up to Week 96/ End of study (EOS))
- Absolute Pain-Numeric Rating Scale (Pain-NRS) and Pruritus-Numeric Rating Scale (Pruritus-NRS) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters(Baseline up to Week 96/ End of study (EOS))
- Change from Baseline in Absolute Pain- and Pruritus-Numeric Rating Scale (NRS) Scores(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS))
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 96/ End of study (EOS))
- Number of Participants with Clinically Significant Change from Baseline in Vital Signs(Baseline up to Week 96/ End of study (EOS))