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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04149587
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Bausch Health Americas, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Anya Loncaric
Principal Investigator Affiliation Bausch Health Americas, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

: Brodalumab 210 mg Q2W

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.

Interventions

Drug: - Brodalumab

Brodalumab will be administered per dose and schedule specified in the arm.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bausch Site 009, Nanaimo, British Columbia, Canada

Status

Recruiting

Address

Bausch Site 009

Nanaimo, British Columbia,

Bausch Site 002, Montréal, Manitoba, Canada

Status

Recruiting

Address

Bausch Site 002

Montréal, Manitoba,

Bausch Site 001, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Bausch Site 001

Winnipeg, Manitoba,

Bausch Site 007, Markham, Ontario, Canada

Status

Recruiting

Address

Bausch Site 007

Markham, Ontario,

Bausch Site 008, Mississauga, Ontario, Canada

Status

Recruiting

Address

Bausch Site 008

Mississauga, Ontario,

Bausch Site 014, North Bay, Ontario, Canada

Status

Recruiting

Address

Bausch Site 014

North Bay, Ontario,

Bausch Site 005, Ottawa, Ontario, Canada

Status

Recruiting

Address

Bausch Site 005

Ottawa, Ontario,

Bausch Site 012, Toronto, Ontario, Canada

Status

Recruiting

Address

Bausch Site 012

Toronto, Ontario,

Bausch Site 010, Waterloo, Ontario, Canada

Status

Recruiting

Address

Bausch Site 010

Waterloo, Ontario,

Bausch Site 011, Drummondville, Quebec, Canada

Status

Recruiting

Address

Bausch Site 011

Drummondville, Quebec,

Bausch Site 003, Surrey, Quebec, Canada

Status

Recruiting

Address

Bausch Site 003

Surrey, Quebec,

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