Clinical trial NCT04229836: Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
Official title: An International, Multicentre, Open- Label, Interventional Phase IV Clinical Study to Investigate the Efficacy and Safety of Tildrakizumab 100 mg in Patients With Moderate- Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Tildrakizumab
Moderate-to-Severe Chronic Plaque Psoriasis
Quality of Life (QoL)
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 178
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 main aim of the study is to evaluate the efficacy, safety and impact on the health-related quality of life (HRQoL) in participants with moderate-to-severe chronic plaque psoriasis who are treated with tildrakizumab 100 milligrams (mg).


Eligibility criteria: Inclusion Criteria:

* Provide signed written and dated informed consent given before any study related activity is performed
* Participants with a diagnosis of moderate to severe plaque psoriasis
* Participants eligible for systemic biologic treatment as assessed by the investigator or having had a primary/secondary failure to treatment with one or more anti-Tumor Necrosis Factor (TNF) biologic agents for psoriasis

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®
* Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
* Other forms of psoriasis than chronic plaque-type
* Current severe and/or uncontrolled psoriatic arthritis (PsA), or participants with PsA that is currently receiving systemic treatment
* Drug-induced psoriasis at the Screening Visit
* Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
* Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit
* Active infection disease or history of recurrent infection
* Active or latent tuberculosis (TB) at Screening visit
* Positive test for human immunodeficiency virus or any other immunosuppressive disease
* Participants with exposure to psoriasis systemic investigational drugs in the previous year
* Live vaccination within 4 weeks prior to the Baseline Visit
* Participants who intend to use any concomitant medication with immunomodulating or systemic corticosteroids

Primary outcomes:
measure: Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
timeFrame: Week 24
measure: Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
timeFrame: Week 24
measure: Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
timeFrame: Baseline (Day 1) and Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving Absolute Dermatology Life Quality Index (DLQI) Scores Between 0-1 at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score Between 0-1 at Week 24.
timeFrame: Week 24
measure: Absolute Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Score of 5, 3, and 1
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Physician Global Assessment (PGA) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Physician Global Assessment (PGA) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1 with At Least a 2-Grade Reduction from Baseline
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Body Surface Area (BSA) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Body Surface Area (BSA) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Pruritus-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Pruritus-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Pain-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Pain-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Scaling-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Change from Baseline in the Absolute Scaling-Numerical Rating Scale (NRS) Score
timeFrame: Baseline (Day 1), Week 4, 16, 24
measure: Absolute Skindex-16 Questionnaire Score at Week 24
timeFrame: Week 24
measure: Change from Baseline in the Absolute Skindex-16 Questionnaire Score at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change from Baseline in the Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
timeFrame: Week 24
measure: Change from Baseline in the Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving a Score Greater Than or Equal to (>=) 1 in the Absolute Patient Benefit Index (PBI) Score at Week 24.
timeFrame: Week 24
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Day 1) up to Week 28
measure: Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
timeFrame: Week 24
measure: Change from Baseline in the Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
timeFrame: Baseline (Day 1) and Week 24
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Investigator Site 9
city: Arezzo
country: Italy
facility: Investigator Site 11
city: Cagliari
country: Italy
facility: Investigator Site 7
city: Catania
country: Italy
facility: Investigator Site 15
city: Erice
country: Italy
facility: Investigator Site 14
city: Genova
country: Italy
facility: Investigator Site 4
city: L'Aquila
country: Italy
facility: Investigator Site 6
city: Milano
country: Italy
facility: Investigator Site 12
city: Modena
country: Italy
facility: Investigator Site 2
city: Napoli
country: Italy
facility: Investigator Site 13
city: Novara
country: Italy
facility: Investigator Site 10
city: Parma
country: Italy
facility: Investigator Site 16
city: Perugia
country: Italy
facility: Investigator Site 18
city: Reggio Calabria
country: Italy
facility: Investigator Site 19
city: Roma
country: Italy
facility: Investigator Site 17
city: Roma
country: Italy
facility: Investigator Site 3
city: Roma
country: Italy
facility: Investigator Site 5
city: Rozzano (MI)
country: Italy
facility: Investigator Site 1
city: Torino
country: Italy
facility: Investigator Site 8
city: A Coruña
country: Spain
facility: Investigator Site 14
city: Albacete
country: Spain
facility: Investigator Site 18
city: Alicante
country: Spain
facility: Investigator Site 12
city: Barcelona
country: Spain
facility: Investigator Site 20
city: Barcelona
country: Spain
facility: Investigator Site 2
city: Barcelona
country: Spain
facility: Investigator Site 3
city: Barcelona
country: Spain
facility: Investigator Site 4
city: Granada
country: Spain
facility: Investigator Site 16
city: Granada
country: Spain
facility: Investigator Site 22
city: Las Palmas
country: Spain
facility: Investigator Site 1
city: Madrid
country: Spain
facility: Investigator Site 19
city: Madrid
country: Spain
facility: Investigator Site 21
city: Madrid
country: Spain
facility: Investigator Site 6
city: Madrid
country: Spain
facility: Investigator Site 7
city: Madrid
country: Spain
facility: Investigator Site 8
city: Madrid
country: Spain
facility: Investigator Site 9
city: Pontevedra
country: Spain
facility: Investigator Site 13
city: Valencia
country: Spain
facility: Investigator Site 11
city: Valencia
country: Spain
facility: Investigator Site 17
city: Zaragoza
country: Spain
facility: Investigator Site 15
Study officials:
affiliation: Almirall, SAS
name: Study Director
role: STUDY_DIRECTOR
References: