An observational study in Psoriasis, sponsored by Bausch Health Americas, Inc.. Active, not recruiting at 42 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bausch Health Americas, Inc. · Observational
This is a phase IV, 12-month observational, prospective, open-label, multi-center study that will be conducted across approximately 50 sites in Canada for an estimated study duration of 32 months. All eligible adult participants who are enrolling into the SILIQ Patient Support Program (PSP) and initiating brodalumab as per routine care may be offered participation in the study. If the participant agrees, their verbal consent and details will be entered into the study platform by the enrolling physician so that the participant can access the electronic informed consent form. Participants who meet the eligibility criteria and provide electronic informed consent will be enrolled in the study. The study observation period will be 12 months (±15 days). Data will be collected on approximately 500 participants across academic and community centers.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 394 is above the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants initiating brodalumab as part of routine clinical care and who meet all of the inclusion and none of the exclusion criteria are eligible to participate in the study.
Exclusion Criteria:
Eligible adult participants who are enrolling into the SILIQ (brodalumab) Patient Support Program (PSP) and initiating brodalumab as per routine care.
Biological: Brodalumab
Participants treated with other therapies, with similar characteristics as the subgroup (participants who can be linked to an administrative health services database) of brodalumab treated participants such as age, gender/sex, comorbidities, and prior biologic experience.
Biological: Matched cohort
Brodalumab
Matched cohort
The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Dermatology Life Quality Index (DLQI) measure is self administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories, ranging from 0 (not at all or not relevant) to 3 (very much) assessing the impact of the disease over the last week. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater health-related quality-of-life impairment.
Time frame: baseline, 3 months, 6 months, 12 months
The percentage change from baseline of the Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) component scores at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) is a validated self-reported 6-item questionnaire that allows quantitative assessment of the effects of PsO on work productivity, daily activities, and classroom impairment. Scores are calculated as percentages of hours worked and percentages of productivity at work on workdays for respondents who are employed at the time of questionnaire completion.
Time frame: baseline, 3 months, 6 months, 12 months
The percentage change from baseline of the Health Utility Index (HUI2) at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Health Utility Index (HUI2) is a 15-item questionnaire that allows researchers to classify the health status of patients and consists of seven attributes (sensation, mobility, emotion, cognition, self-care, pain, and fertility). Health state levels for descriptive responses are converted to health utilities scores using single- and multi-attribute utility functions that consist of look-up tables and mathematical formulae. Utility values for HUI2 range from -0.03 to 1.00, where a value of 1.00 indicates perfect health and a score of 0.00 corresponds to death. Negative scores represent health states considered to be worse than death.
Time frame: baseline, 3 months, 6 months, 12 months
The mean Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores at baseline, 3 months, 6 months, and 12 months post-brodalumab initiation.
The self-administered Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire is along 4 dimensions: medication effectiveness, side effects of use, convenience of use, and global/overall satisfaction. The scale for TSQM scores ranges from 0 (extremely dissatisfied) to 100 (extremely satisfied).
Time frame: baseline, 3 months, 6 months, 12 months
The number and percentage of patients on brodalumab at baseline, 3 months, 6 months, and 12 months post-initiation by key patient demographics and clinical characteristics.
Key demographics and clinical characteristics include: prior biologic experience, age, gender, province, disease duration, number of comorbidities.
Time frame: baseline, 3 months, 6 months, 12 months
The number and percentage of patients that initiated brodalumab achieving a Psoriasis Area Severity Index (PASI) response of 75, 90 or 100 at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Psoriasis Area Severity Index (PASI) score (0 to 72) is a calculation of plaque qualities, including induration/infiltration (plaque thickness), erythema, and desquamation (scaling), and the area involved with PsO (48). The investigator or qualified designee will score plaque erythema, scaling and induration (on a scale of 0 to 4) and area of involvement (on a scale of 0 to 6) for 4 body areas: head and neck, upper extremities, trunk, and lower extremities.
Time frame: baseline, 3 months, 6 months, 12 months
The number and percentage of patients that initiated brodalumab achieving an Static Physicians Global Assessment (sPGA) score of 0 or 1 at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Static Physicians Global Assessment (sPGA) scale (0 \[clear\] to 4 \[severe\]) is designed to evaluate the assessor's global assessment of the patient's psoriasis.
Time frame: baseline, 3 months, 6 months, 12 months
The number and percentage of patients that initiated brodalumab achieving a 2 grade or more improvement compared to baseline of the Static Physicians Global Assessment (sPGA) score at 3 months, 6 months, and 12 months post-brodalumab initiation.
The Static Physicians Global Assessment (sPGA) scale (0 \[clear\] to 4 \[severe\]) is designed to evaluate the assessor's global assessment of the patient's psoriasis.
Time frame: baseline, 3 months, 6 months, 12 months
The percentage change from baseline of the Psoriasis Symptom Inventory (PSI) at 3, 6, and 12 months post-brodalumab initiation.
Psoriasis Symptom Inventory (PSI): The severity of itch, redness, scaling, burning, stinging, cracking, flaking, and pain over the last 24 hours is assessed on a scale of 0 to 4 (0 - not at all, 1- mild, 2 - moderate, 3- severe, 4- very severe) for a total score of 32, with higher scores indicating more severe disease
Time frame: baseline, 3 months, 6 months, 12 months
The number and percentage of Adverse Events (AEs) or (Serious Adverse Events) SAEs reported over 12 months post-brodalumab initiation.
Time frame: 12 months
Reasons for discontinuation of brodalumab therapy.
Discontinuation reason is captured on the case report form.
Time frame: 12 months
The number and percentage of patients who initiated brodalumab and remained on treatment after 3 months, 6 months and 12 months post-brodalumab initiation.
Time frame: 12 months
The mean and median time to brodalumab discontinuation.
Time frame: 12 months
The number of patients encountering psoriasis-related physician
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related physician
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering hospital visit
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering hospital visit
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering emergency room (ER) visits
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering emergency room (ER) visits
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering psoriasis-related procedures
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related procedures
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.
Time frame: baseline, 3 months, 6 months, 12 months
The number of psoriasis-related physician encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The associated costs of psoriasis-related physician encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The number of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The associated costs of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The number of emergency room (ER) visit encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The associated costs of emergency room (ER) visit encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The number of psoriasis-related procedures encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
The associated costs of psoriasis-related procedures encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.