A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen

Bausch Health

Status: Completed

Conditions: Psoriasis

Treatments: Drug: Brodalumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04149587

BHS-CAN-DERM-002

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

252 participants in 1 patient group

Brodalumab 210 mg Q2W

Description:

Participants will receive brodalumab 210 milligrams (mg) administered as 1 subcutaneous injection at Day 1 and at Weeks 1 and 2 followed by 210 mg every 2 weeks (Q2W) thereafter until Week 26.

Treatment:

Drug: Brodalumab