Psoriasis (PsO)PRO/PsONCT07370766
Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada
An observational study of Psoriasis (PsO) and Moderate to Severe Psoriasis, run by Chronicle Academy at 7 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO), Moderate to Severe Psoriasis
- How many people
- 80 participants
- Where
- 7 sitesCanada
- Study dates
- 25 Nov 2025to 30 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
Benchmark Dermatology
Burlington, Ontario, L7L 3E5
Daniel Wong, MD, FRCPC, (905) 849-5057, dwong2014@gmail.com
Daniel Wong, MD, FRCPC
- Recruiting
Locke Dermatology
Hamilton, Ontario, L8P 4B4
Huma Khurrum, (905) 364-8468, Locke.derm_research@yahoo.com
Mohannad Abu-Hilal, MD, MRCP UK
- Recruiting
Panorama Dermatology Clinic
Kanata, Ontario, K2T 0N7
Isra A., (613) 407-7546, panoramaderm@gmail.com
Feras Al Ghazawi, MD
- Recruiting
Factor Dermatology
Ottawa, Ontario, K2A 3Z3
Marlee Sanderson, (613) 691-1646, marleemsanderson@gmail.com
Sophia Colantonio, BSc, MPH, MD, FRCPC, FAAD, DAB
- Recruiting
Vital Medical Centre
Ottawa, Ontario
Maham Sajid, (613) 248-1010, maham@darclinicalresearch.com
Brooke Butler, brooke@darclinicalresearch.com
- Recruiting
Elevate Dermatology
Pickering, Ontario
Sophie Lee, (905) 418-0808, sophie@elevatedermatology.ca
Kim Blakely, MD, PhD
- Recruiting
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T0G3
Zarin Nawar, (306) 373-0040, research@saskatoondermatology.ca
Kyle Cullingham, BA, BSc, MSc, MD, FRCPC
About this study
Official title: 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 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
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | all participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Evaluated using DLQI questionnaire; DLQI-Relevant adjusted for non-relevant answers
Measured: 52 weeks
Evaluate efficacy of tildrakizumab using Psoriasis Area Severity Index (PASI) in patients with Fitzpatrick skin types III and above
Absolute and percent change from baseline to Week 16 and 52. Number and percent of patients achieving PASI 75, PASI 90, PASI 100 at Week 16 and 52
Measured: Week 16, Week 52
Evaluate efficacy of tildrakizumab using Body Surface Area (BSA) in patients with Fitzpatrick skin types III and above
Absolute and percent change from baseline to Week 16 and 52
Measured: Week 16, Week 52
Evaluate efficacy of tildrakizumab using static Physician Global Assessment (sPGA) in patients with Fitzpatrick skin types III and above
Absolute and percent change from baseline to Week 16 and 52. Number and percent of participants achieving score 0 or 1 with at least a 2-grade reduction from baseline at Week 16 and 52
Measured: Week 16, Week 52
Impact of tildrakizumab treatment on quality of life
Measured using Skindex-16 patient questionnaire. It consists of 16 items that assess three key domains affected by skin disease: symptoms, emotional impact, and functioning. Patients are asked to rate how often they experienced various impacts from their skin condition over the last seven days, using a seven-point response scale (0-6) that ranges from: 0 (never bothered) to 6 (always bothered). Absolute and percent change from baseline to Week 16 and 52 are calculated.
Measured: Week 16, Week 52
Impact of tildrakizumab treatment on sleep
Measured using Medical Outcomes Study Sleep Scale (MOS-Sleep) patient questionnaire. Absolute and percent change from baseline to Week 16 and 52. Consisting of 12 items, MOS-Sleep measures subjective experiences of sleep across several different domains. Question 1 is a numerical scale 1-5, where 5 indicates most difficulty to fall asleep; question 2 asks average number of hours slept per night in last 4 weeks; questions 3-12 are numerical scale 1-6, where 1 is "all of the time" and 6 is "none of the time".
Measured: Week 16, Week 52
Impact of tildrakizumab treatment on discomfort
Measured using Worst Itch Numerical Rating Scale (WI-NRS). Participants will use the NRS to rate their itch and skin pain, separately, on a scale ranging from 0 to 10, where: 0 indicates no skin pain or no itch, and 10 indicates the worst imaginable pain or itch. A 24-hour recall period will be applied.
Absolute and percent change from baseline to Week 16 and 52 are calculated.
Measured: Week 16, Week 52
Impact of tildrakizumab on skin pain
Measured using Skin Pain Numerical Rating Scale (SP-NRS) . Participants will use the NRS to rate their itch and skin pain, separately, on a scale ranging from 0 to 10, where: 0 indicates no skin pain or no itch, and 10 indicates the worst imaginable pain or itch. A 24-hour recall period will be applied.
Absolute and percent change from baseline to Week 16 and Week 52 are calculated.
Measured: Week 16, Week 52
Evaluate the correlation between clinical improvement (PASI, BSA, sPGA) and QoL outcomes, identifying how improvements in disease severity align with enhancements in QoL measures.
Change from baseline to Week 16 and 52 on PASI, BSA, sPGA vs. Change from baseline at Week 16 and 52 on DLQI, DLQI-R, Skindex-16, and MOS-Sleep
Measured: Week 16, Week 52
Evaluate the safety of tildrakizumab over the course of the study
Number and percent of treatment emergent Adverse Events and Serious Adverse Events over time. Number of events of unusual failure in efficacy over course of study.
Measured: Baseline to Week 52
Assess patient adherence and satisfaction with tildrakizumab treatment
Treatment satisfaction questionnaire for medication (TSQM-9) score at Week 16 and 52. The TSQM-9 measures satisfaction across four key domains: a) Effectiveness: How well the treatment controls symptoms b) Side Effects: The patient's experience of side effects, if any, c) Convenience: How easy it is to use the treatment, d) Global Satisfaction: The overall satisfaction with the medication. Participants will rate individual items using a 7-point Likert scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied." Number and type of participant withdrawals. Number of missed tildrakizumab treatments (self-report)
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start25 Nov 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chronicle Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370766
- Sponsor's protocol ID
- PRO/PsO-01
- Acronym
- PRO/PsO
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No