Tildrakizumab for symptoms and quality of life in Canadians with moderate-to-severe plaque psoriasis (Fitzpatrick III+)

A Real-world, Longitudinal Observational Study of the Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada

This study will test how tildrakizumab affects symptoms, safety, and quality of life in adults in Canada with moderate-to-severe plaque psoriasis who are starting treatment through the ILUMYA SUPPORT® Program and have Fitzpatrick skin types III or higher.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chronicle Academy (Academic / other)
• Drugs / interventions: tildrakizumab, methotrexate
• Locations: 6 sites (Burlington, Ontario and 5 other locations)
• Trial ID: NCT07370766 on ClinicalTrials.gov

What this trial studies

This is a multi-centre, non-interventional, open-label prospective observational study conducted across Canada over 52 weeks. About 80 adults with moderate-to-severe plaque psoriasis (Fitzpatrick III+) who are initiating tildrakizumab as part of routine care will be enrolled. Data collection will focus on patient-reported outcomes, safety events, and real-world effectiveness while patients receive standard clinical care; there is no randomization or study-assigned treatment. The study aims to fill gaps in Canadian real-world evidence, especially for patients with darker skin phototypes.

Who should consider this trial

Good fit: Adults (18+) with moderate-to-severe chronic plaque psoriasis, Fitzpatrick skin type III or above, who are planning to start tildrakizumab through the ILUMYA SUPPORT® Program and can read English and give informed consent are ideal candidates.

Not a fit: Patients who are already receiving other oral systemic psoriasis therapies, have known hypersensitivity to tildrakizumab, are Fitzpatrick I–II, or are not starting tildrakizumab will not be eligible and are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the study could provide evidence that tildrakizumab improves symptoms and quality of life and is safe in the targeted Canadian patient group.

How similar studies have performed: Randomized phase 3 trials and some real-world reports outside Canada have shown tildrakizumab to be effective and well tolerated, but Canadian real-world data—particularly in Fitzpatrick III+ patients—remain limited.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 years or older.
2. Diagnosis of moderate-to-severe chronic plaque-type PsO with Fitzpatrick scale type III or above (BSA \>/=3%).
3. Candidate for phototherapy and/or systemic therapy.
4. 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.
5. Must be able to read, understand, and communicate in English.
6. Must be willing to participate in the study and capable to provide informed consent
7. Able to comply with all study procedures and attend all study visits

Exclusion Criteria:

1. Known hypersensitivity to tildrakizumab, its excipients, or components of the container, as outlined in the Product Monograph.
2. Concurrently taking any oral medication for treatment of PsO (e.g. methotrexate, cyclosporin, acitretin)
3. Diagnosis of only palmoplantar psoriasis
4. Concurrent medical condition or significant comorbidities that, in the investigator's opinion, would prevent participation in the study or interfere with study assessments
5. Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding.
6. Prior (within 30 days) or actively participating in other interventional clinical trial(s).
7. Unable or unwilling to comply with study procedures including completing questionnaire.
8. 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

Where this trial is running

Burlington, Ontario and 5 other locations

• Burlington Skin and Wellness — Burlington, Ontario, Canada (Recruiting)
• Locke Dermatology — Hamilton, Ontario, Canada (Recruiting)
• Panorama Dermatology Clinic — Kanata, Ontario, Canada (Recruiting)
• Centricity Research London Victoria Multispecialty — London, Ontario, Canada (Recruiting)
• Factor Dermatology — Ottawa, Ontario, Canada (Recruiting)
• Saskatoon Dermatology Centre — Saskatoon, Saskatchewan, Canada (Recruiting)

Conditions Psoriasis; Moderate to Severe Psoriasis; psoriasis; moderate to severe psoriasis; Fitzpatrick scale; tildrakizumab; patient reported outcomes