Recruiting

Tildrakizumab

Sponsor:

Chronicle Academy

Code:

NCT07370766

Conditions

Psoriasis (PsO)

Moderate to Severe Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07370766

Start date

Nov 25, 2025

Status verified date

Jan, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Cohort

all participants

Primary outcome measure

  • 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 [ Time Frame: 16 weeks ]

Central Contacts and Locations

Locations

Burlington Skin and Wellness

Recruiting

Burlington, Ontario, Canada, L7L 3E5

Contacts

Principal Investigator:

Daniel Wong, MD, FRCPC

Locke Dermatology

Recruiting

Hamilton, Ontario, Canada, L8P 4B4

Contacts

Principal Investigator:

Mohannad Abu-Hilal, MD, MRCP UK

Panorama Dermatology Clinic

Recruiting

Kanata, Ontario, Canada, K2T 0N7

Contacts

Principal Investigator:

Feras Al Ghazawi, MD

Centricity Research London Victoria Multispecialty

Recruiting

London, Ontario, Canada, N6A 2C2

Contacts

Principal Investigator:

Jeffery Cowger, MD

Factor Dermatology

Recruiting

Ottawa, Ontario, Canada, K2A 3Z3

Contacts

Principal Investigator:

Sophia Colantonio, BSc, MPH, MD, FRCPC, FAAD, DAB

Saskatoon Dermatology Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7T0G3

Contacts

Principal Investigator:

Kyle Cullingham, BA, BSc, MSc, MD, FRCPC

More Information

Sponsor

Chronicle Academy

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chronicle Academy on 2026-01-27.