An observational study in Psoriasis (PsO) and Moderate to Severe Psoriasis, sponsored by Chronicle Academy. Recruiting at 7 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Chronicle Academy · Observational
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 80 is below the median of 199 across 407 observational studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Chronicle Academy as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all participants
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
Time frame: 16 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Baseline to Week 52
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for May 2027, 18 months after the start.
Of 92 non-industry observational studies under Psoriasis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 119. This study's planned 18 months is below that.
Counting every sponsor, half of 173 studies reached it within 37 months; a quarter within 23 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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