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

NCT04149587 | Completed

• 1 other identifier: BHS-CAN-DERM-002
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 11

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26

  PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 100 responders were defined as participants achieving 100% improvement at Week 26.

  Week 26

Secondary Outcomes (12)

• Percentage of Participants Achieving Static Physicians Global Assessment (sPGA) Score 0/1

  Weeks 1, 2, 4, 16, and 26

• Change From Baseline in Mean sPGA * Body Surface Area (BSA) Score at Weeks 1, 2, 4, 16, and 26

  Baseline, Weeks 1, 2, 4, 16, and 26

• Percentage of Participants Achieving PASI 75 and PASI 90

  Weeks 1, 2, 4, 16, and 26

• Percentage of Participants Achieving PASI 100 at Weeks 1, 2, 4, and 16

  Weeks 1, 2, 4, and 16

• Change From Baseline in Psoriasis Symptoms Inventory (PSI) Score at Weeks 1, 2, 4, 16, and 26

  Baseline, Weeks 1, 2, 4, 16, and 26

Study Arms (1)

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.

Drug: Brodalumab

Interventions

Brodalumab DRUG

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

Also known as: SILIQ®

Brodalumab 210 mg Q2W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (11)

Bausch Site 009

Nanaimo, British Columbia, Canada

Location

Bausch Site 002

Montréal, Manitoba, Canada

Location

Bausch Site 001

Winnipeg, Manitoba, Canada

Location

Bausch Site 007

Markham, Ontario, Canada

Location

Bausch Site 008

Mississauga, Ontario, Canada

Location

Bausch Site 014

North Bay, Ontario, Canada

Location

Bausch Site 005

Ottawa, Ontario, Canada

Location

Bausch Site 012

Toronto, Ontario, Canada

Location

Bausch Site 010

Waterloo, Ontario, Canada

Location

Bausch Site 011

Drummondville, Quebec, Canada

Location

Bausch Site 003

Surrey, Quebec, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anya Loncaric

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: September 30, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

CA (11)