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)
NCT ID: NCT04229836
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
178 participants
INTERVENTIONAL
2019-12-17
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tildrakizumab
Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).
Tildrakizumab 100 mg Solution for Injection
Participants will be treated with tildrakizumab 100 mg.
Interventions
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Tildrakizumab 100 mg Solution for Injection
Participants will be treated with tildrakizumab 100 mg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Almirall, SAS
Locations
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Investigator Site 9
Ancona, , Italy
Investigator Site 11
Arezzo, , Italy
Investigator Site 7
Cagliari, , Italy
Investigator Site 15
Catania, , Italy
Investigator Site 14
Erice, , Italy
Investigator Site 4
Genova, , Italy
Investigator Site 6
L’Aquila, , Italy
Investigator Site 12
Milan, , Italy
Investigator Site 2
Modena, , Italy
Investigator Site 13
Napoli, , Italy
Investigator Site 10
Novara, , Italy
Investigator Site 16
Parma, , Italy
Investigator Site 18
Perugia, , Italy
Investigator Site 19
Reggio Calabria, , Italy
Investigator Site 17
Roma, , Italy
Investigator Site 3
Roma, , Italy
Investigator Site 5
Roma, , Italy
Investigator Site 1
Rozzano (MI), , Italy
Investigator Site 8
Torino, , Italy
Investigator Site 14
A Coruña, , Spain
Investigator Site 18
Albacete, , Spain
Investigator Site 12
Alicante, , Spain
Investigator Site 20
Barcelona, , Spain
Investigator Site 2
Barcelona, , Spain
Investigator Site 3
Barcelona, , Spain
Investigator Site 4
Barcelona, , Spain
Investigator Site 16
Granada, , Spain
Investigator Site 22
Granada, , Spain
Investigator Site 1
Las Palmas, , Spain
Investigator Site 19
Madrid, , Spain
Investigator Site 21
Madrid, , Spain
Investigator Site 6
Madrid, , Spain
Investigator Site 7
Madrid, , Spain
Investigator Site 8
Madrid, , Spain
Investigator Site 9
Madrid, , Spain
Investigator Site 13
Pontevedra, , Spain
Investigator Site 11
Valencia, , Spain
Investigator Site 17
Valencia, , Spain
Investigator Site 15
Zaragoza, , Spain
Countries
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Other Identifiers
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M-14745-42
Identifier Type: -
Identifier Source: org_study_id
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