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)

NCT04229836 | Completed Phase 4

• 1 other identifier: M-14745-42
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 39

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).

Conditions

Plaque Psoriasis

Keywords

Tildrakizumab; Moderate-to-Severe Chronic Plaque Psoriasis; Quality of Life (QoL)

Outcome Measures

Primary Outcomes (4)

• Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24

  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).

  Week 24

• Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24

  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). Change from baseline will be calculated by subtracting post-dose value baseline value.

  Baseline (Day 1) and Week 24

• Absolute Dermatology Life Quality Index (DLQI) Score at Week 24

  DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.

  Week 24

• Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score at Week 24

  DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.

  Baseline (Day 1) and Week 24

Secondary Outcomes (31)

• Percentage of Participants Achieving Absolute Dermatology Life Quality Index (DLQI) Scores Between 0-1 at Week 24

  Week 24

• Percentage of Participants Achieving Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score Between 0-1 at Week 24.

  Week 24

• Absolute Dermatology Life Quality Index (DLQI) Score

  Baseline (Day 1), Week 4, 16, 24

• Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score

  Baseline (Day 1), Week 4, 16, 24

• Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score

  Baseline (Day 1), Week 4, 16, 24

Study Arms (1)

Tildrakizumab

EXPERIMENTAL

Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).

Drug: Tildrakizumab 100 mg Solution for Injection

Interventions

Tildrakizumab 100 mg Solution for Injection DRUG

Participants will be treated with tildrakizumab 100 mg.

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (39)

Investigator Site 9

Ancona, Italy

Location

Investigator Site 11

Arezzo, Italy

Location

Investigator Site 7

Cagliari, Italy

Location

Investigator Site 15

Catania, Italy

Location

Investigator Site 14

Erice, Italy

Location

Investigator Site 4

Genova, Italy

Location

Investigator Site 6

L’Aquila, Italy

Location

Investigator Site 12

Milan, Italy

Location

Investigator Site 2

Modena, Italy

Location

Investigator Site 13

Napoli, Italy

Location

Investigator Site 10

Novara, Italy

Location

Investigator Site 16

Parma, Italy

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Investigator Site 18

Perugia, Italy

Location

Investigator Site 19

Reggio Calabria, Italy

Location

Investigator Site 17

Roma, Italy

Location

Investigator Site 3

Roma, Italy

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Investigator Site 5

Roma, Italy

Location

Investigator Site 1

Rozzano (MI), Italy

Location

Investigator Site 8

Torino, Italy

Location

Investigator Site 14

A Coruña, Spain

Location

Investigator Site 18

Albacete, Spain

Location

Investigator Site 12

Alicante, Spain

Location

Investigator Site 20

Barcelona, Spain

Location

Investigator Site 2

Barcelona, Spain

Location

Investigator Site 3

Barcelona, Spain

Location

Investigator Site 4

Barcelona, Spain

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Investigator Site 16

Granada, Spain

Location

Investigator Site 22

Granada, Spain

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Investigator Site 1

Las Palmas, Spain

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Investigator Site 19

Madrid, Spain

Location

Investigator Site 21

Madrid, Spain

Location

Investigator Site 6

Madrid, Spain

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Investigator Site 7

Madrid, Spain

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Investigator Site 8

Madrid, Spain

Location

Investigator Site 9

Madrid, Spain

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Investigator Site 13

Pontevedra, Spain

Location

Investigator Site 11

Valencia, Spain

Location

Investigator Site 17

Valencia, Spain

Location

Investigator Site 15

Zaragoza, Spain

Location

MeSH Terms

Interventions

tildrakizumab; Solutions; Injections

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Study Director

  Almirall, SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: December 17, 2019
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

IT (19); ES (20)