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

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ClinicalTrials.gov Identifier: NCT04149587
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date October 31, 2019
First Posted Date November 4, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date September 30, 2019
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2019)
Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 31, 2019)
  • Percentage of Participants Achieving Static Physicians Global Assessment (sPGA) Score 0/1 [ Time Frame: Weeks 1, 2, 4, 16, and 26 ]
    The sPGA scale (0 [clear] to 4 [severe]) will be completed by the investigator or qualified designee and is designed to evaluate the assessor's global assessment of the participant's psoriasis. 0 (clear) = No signs of psoriasis; postinflammatory hyperpigmentation may be present, 1 (almost clear) = No thickening; normal to pink coloration; no to minimal focal scaling, 2 (mild) = Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling, 3 (moderate) = Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling, 4 (severe) = Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
  • Change From Baseline in Mean sPGA * Body Surface Area (BSA) Score at Weeks 1, 2, 4, 16, and 26 [ Time Frame: Baseline, Weeks 1, 2, 4, 16, and 26 ]
    The area of body surface affected by psoriasis will be estimated by the investigator as a percentage of the participant's total BSA wherein the area of the participant's palm will be considered as 1% of total BSA. sPGA of disease severity is measured by the investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease).
  • Percentage of Participants Achieving PASI 75 and PASI 90 [ Time Frame: Weeks 1, 2, 4, 16, and 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 75 responders were defined as participants achieving ≥75% improvement at specified timepoints. PASI 90 responders were defined as participants achieving ≥90% improvement at specified timepoints.
  • Percentage of Participants Achieving PASI 100 at Weeks 1, 2, 4, and 16 [ Time Frame: Weeks 1, 2, 4, and 16 ]
    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 specified timepoints.
  • Change From Baseline in Psoriasis Symptoms Inventory (PSI) Score at Weeks 1, 2, 4, 16, and 26 [ Time Frame: Baseline, Weeks 1, 2, 4, 16, and 26 ]
    The PSI is a psoriasis-specific patient-reported outcome that measures the severity of psoriasis signs and symptoms based on an 8-item scale. 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 (not at all, mild, moderate, severe, or very severe) for a total score of 32, with higher scores indicating more severe disease.
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 1, 2, 4, 16, and 26 [ Time Frame: Baseline, Weeks 1, 2, 4, 16, and 26 ]
    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult participants with skin conditions. The 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.
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Weeks 1, 2, 4, 16, and 26 [ Time Frame: Baseline, Weeks 1, 2, 4, 16, and 26 ]
    The HADS is a self-reported questionnaire that assesses anxiety and depression. The scale includes two subscales, specifically depression and anxiety. Each subscale has 7 items, for a total of 14 items with a total score ranging from 0 to 21 for each scale. Participants report the relative frequency of symptoms over the past week using a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a greater likelihood of depression or anxiety.
  • Change From Baseline in EuroQoL-5 Dimensional (EQ-5D) With Psoriasis Bolt-on (EQ-PSO) Score at Weeks 1, 2, 4, 16, and 26 [ Time Frame: Baseline, Weeks 1, 2, 4, 16, and 26 ]
    The EQ-PSO is a psoriasis-specific adaptation of the EQ-5D, a standardized measure of health status that can be used to provide a simple, generic measure of health outcome. The EQ-5D comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which is assessed by the respondent according to 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems.). The EQ-PSO includes two additional, psoriasis-specific dimensions: skin irritation and self-confidence.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline (Week 0) up to end of treatment (Week 26) ]
  • Time to Onset of Action [ Time Frame: Baseline up to Week 26 ]
  • Number of Participants Adhering to the Treatment [ Time Frame: Baseline up to Week 26 ]
  • 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 [ Time Frame: Week 16 and 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 75 responders were defined as participants achieving ≥75% improvement at specified timepoints. PASI 90 responders were defined as participants achieving ≥90% improvement at specified timepoints. PASI 100 responders were defined as participants achieving 100% improvement at specified timepoints.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Psoriasis
Intervention Drug: Brodalumab
Brodalumab will be administered per dose and schedule specified in the arm.
Other Name: SILIQ®
Study Groups/Cohorts 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.
Intervention: Drug: Brodalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 31, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clinical Trial Manager 1 514-904-4863 Alexandre.Brkovic@bauschhealth.com
Contact: Susan Harris Susan.Harris@bauschhealth.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04149587
Other Study ID Numbers BHS-CAN-DERM-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor Bausch Health Americas, Inc.
Collaborators Not Provided
Investigators
Study Director: Anya Loncaric Bausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date October 2020