Clinical trial NCT04149587: A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Official title: A Canadian Phase IV, Multicenter, Single-Arm Study To Evaluate the Effectiveness of Treatment With Brodalumab (SILIQ) in Psoriasis Patients With Inadequate Response to Their Current Biologic Agent Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who did not respond adequately to treatment with their current biological regimen as per the investigator clinical judgement

Brief summary: This multicenter, prospective, observational, single-arm, 26-week study will evaluate the effectiveness, safety and tolerability of brodalumab subcutaneous injection in participants with psoriasis with inadequate response to their current biologic agent regimen.


Eligibility criteria: Inclusion Criteria:

* Participant has enrolled in the brodalumab patient support program (PSP).
* Participant has provided informed consent, using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF).
* Confirmed diagnosis with moderate to severe plaque psoriasis.
* On stable treatment with a biologic for a minimum of 12 weeks, and not having achieved adequate therapeutic response, as per the investigator's judgment, for example BSA of greater than or equal to (≥) 1% and physicians global assessment (PGA) of ≥3.
* Participant must be able to understand and communicate with the investigator, as well as complete the study questionnaires, in one of the available and validated languages.
* Participants participating in other observational studies or registries are permitted to enroll in this study at the same time.

Exclusion Criteria:

* Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 drug half-lives (whichever is longer) prior to receiving the first dose of brodalumab (Day 1).
* Participant has a history of any psychiatric disorder or substance abuse that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* Participant has previous history of suicidal ideation and/or behavior or report suicidal ideation and/or behavior during the study.
* Presence of any other serious and/or uncontrolled medical condition that, in the opinion of the investigator, prohibits the participant from participating in the study.
* Participant has a body mass index (BMI) greater than (\>) 40 kilograms/square meter (kg/m\^2) during the screening phase or during the study.
* Any contraindication as per the product monograph: Brodalumab injection is contraindicated in participants with clinically significant hypersensitivity to brodalumab or to any of the excipients or component of the container. Brodalumab is contraindicated in participants with Crohn's disease.

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of Participants Achieving Static Physicians Global Assessment (sPGA) Score 0/1
timeFrame: Weeks 1, 2, 4, 16, and 26
measure: Change From Baseline in Mean sPGA * Body Surface Area (BSA) Score at Weeks 1, 2, 4, 16, and 26
timeFrame: Baseline, Weeks 1, 2, 4, 16, and 26
measure: Percentage of Participants Achieving PASI 75 and PASI 90
timeFrame: Weeks 1, 2, 4, 16, and 26
measure: Percentage of Participants Achieving PASI 100 at Weeks 1, 2, 4, and 16
timeFrame: Weeks 1, 2, 4, and 16
measure: Change From Baseline in Psoriasis Symptoms Inventory (PSI) Score at Weeks 1, 2, 4, 16, and 26
timeFrame: Baseline, Weeks 1, 2, 4, 16, and 26
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 1, 2, 4, 16, and 26
timeFrame: Baseline, Weeks 1, 2, 4, 16, and 26
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Weeks 1, 2, 4, 16, and 26
timeFrame: Baseline, Weeks 1, 2, 4, 16, and 26
measure: Change From Baseline in EuroQoL-5 Dimensional (EQ-5D) With Psoriasis Bolt-on (EQ-PSO) Score at Weeks 1, 2, 4, 16, and 26
timeFrame: Baseline, Weeks 1, 2, 4, 16, and 26
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline (Week 0) up to end of treatment (Week 26)
measure: Time to Onset of Action
timeFrame: Baseline up to Week 26
measure: Number of Participants Adhering to the Treatment
timeFrame: Baseline up to Week 26
measure: Percentage of Participants Achieving PASI 75, PASI 90, and PASI 100 at Week 16 and 26 According to the Last Biologic Agent That the Participant was Receiving Before Initiating Treatment With Brodalumab
timeFrame: Week 16 and 26
Other outcomes:
Locations:
city: Nanaimo
country: Canada
facility: Bausch Site 009
state: British Columbia
city: Montréal
country: Canada
facility: Bausch Site 002
state: Manitoba
city: Winnipeg
country: Canada
facility: Bausch Site 001
state: Manitoba
city: Markham
country: Canada
facility: Bausch Site 007
state: Ontario
city: Mississauga
country: Canada
facility: Bausch Site 008
state: Ontario
city: North Bay
country: Canada
facility: Bausch Site 014
state: Ontario
city: Ottawa
country: Canada
facility: Bausch Site 005
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site 012
state: Ontario
city: Waterloo
country: Canada
facility: Bausch Site 010
state: Ontario
city: Drummondville
country: Canada
facility: Bausch Site 011
state: Quebec
city: Surrey
country: Canada
facility: Bausch Site 003
state: Quebec
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Anya Loncaric
role: STUDY_DIRECTOR
References: