Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada

NCT07370766 | Recruiting

• 1 other identifier: PRO/PsO-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multi-centre, non-interventional, open-label, prospective observational study that will be conducted across Canada over 52-week duration. Approximately 80 patients who are initiating tildrakizumab as part of their routine care through the ILUMYA SUPPORT® Program and meet the study's eligibility criteria will be enrolled. Specifically, the study will enroll patients with Fitzpatrick scale skin types III and above. The real-world impact, safety and effectiveness of tildrakizumab on patients with moderate-to-severe plaque psoriasis (PsO) remain largely undocumented in Canada, despite its approval in 2018. Given Canada's diverse population, this study presents an opportunity to evaluate tildrakizumab's quality of life, safety and effectiveness in specific demographic groups, particularly those patients with Fitzpatrick scale skin type III and above. The findings from this study will help optimize care, address unmet needs, and ensure that treatment outcomes are inclusive and reflective of Canada's diverse population.

Conditions

Psoriasis (PsO); Moderate to Severe Psoriasis

Keywords

psoriasis; moderate to severe psoriasis; Fitzpatrick scale; tildrakizumab; patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of tildrakizumab on the Dermatology Life Quality Index (DLQI and DLQI-R) in patients of Fitzpatrick skin type III and above to 16 weeks

  DLQI consists of 10 items designed to assess multiple domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients respond to each item based on their experiences over the past week, using a four-point scale that ranges from: 0 (not at all or not relevant), 1 (a little), 2 (a lot), 3 (very much). Total DLQI score is calculated by summing the scores for all 10 items, resulting in a possible range from 0 to 30, where higher scores indicate greater impairment in QoL due to the skin condition. DLQI-Relevant adjusted for non-relevant answers

  16 weeks

Secondary Outcomes (11)

• Evaluate the impact of tildrakizumab on DLQI and DLQI-R in patients of Fitzpatrick skin type III and above to 52 weeks

  52 weeks

• Evaluate efficacy of tildrakizumab using Psoriasis Area Severity Index (PASI) in patients with Fitzpatrick skin types III and above

  Week 16, Week 52

• Evaluate efficacy of tildrakizumab using Body Surface Area (BSA) in patients with Fitzpatrick skin types III and above

  Week 16, Week 52

• Evaluate efficacy of tildrakizumab using static Physician Global Assessment (sPGA) in patients with Fitzpatrick skin types III and above

  Week 16, Week 52

• Impact of tildrakizumab treatment on quality of life

  Week 16, Week 52

Study Arms (1)

Study Cohort

all participants

Eligibility Criteria

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

Study Population

Patients with moderate-to-severe psoriasis (PsO) planning to initiate treatment with tildrakizumab and meet Fitzpatrick scale skin type III or above. Patients that are either naïve to PsO treatment with a biologic or those who have previously been exposed to a biologic PsO treatment will be eligible for the study.

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of moderate-to-severe chronic plaque-type PsO with Fitzpatrick scale type III or above (BSA \>/=3%).
• Candidate for phototherapy and/or systemic therapy.
• Planning to initiate tildrakizumab as part of routine clinical care through the ILUMYA SUPPORT® Program for the treatment of plaque PsO but has not yet received their first dose.
• a. Decision to treat with tildrakizumab must be made independently of and prior to study recruitment.
• Must be able to read, understand, and communicate in English.
• Must be willing to participate in the study and capable to provide informed consent
• Able to comply with all study procedures and attend all study visits

You may not qualify if:

• Known hypersensitivity to tildrakizumab, its excipients, or components of the container, as outlined in the Product Monograph.
• Concurrently taking any oral medication for treatment of PsO (e.g. methotrexate, cyclosporin, acitretin)
• Diagnosis of only palmoplantar psoriasis
• Concurrent medical condition or significant comorbidities that, in the investigator's opinion, would prevent participation in the study or interfere with study assessments
• Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding.
• Prior (within 30 days) or actively participating in other interventional clinical trial(s).
• Unable or unwilling to comply with study procedures including completing questionnaire.
• Any other condition that, in the opinion of the investigator, could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results

Sponsors & Collaborators

• Chronicle Academy: lead

Study Sites (6)

Burlington Skin and Wellness

Burlington, Ontario, L7L 3E5, Canada

RECRUITING

Locke Dermatology

Hamilton, Ontario, L8P 4B4, Canada

RECRUITING

Panorama Dermatology Clinic

Kanata, Ontario, K2T 0N7, Canada

RECRUITING

Centricity Research London Victoria Multispecialty

London, Ontario, N6A 2C2, Canada

RECRUITING

Factor Dermatology

Ottawa, Ontario, K2A 3Z3, Canada

RECRUITING

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, S7T0G3, Canada

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 27, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)