Trial · NCT04149587
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
NCT04149587, Completed, Bausch Health Americas, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen. Trials, record NCT04149587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04149587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
- NCT number
- NCT04149587
- Status
- Completed
- Enrollment
- 252 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriasis
- Interventions
- Brodalumab
- First posted
- 2019-11-04
- Last updated
- 2022-07-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26 | 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. |
| Secondary | Percentage of Participants Achieving Static Physicians Global Assessment (sPGA) Score 0/1 | 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. |
| Secondary | 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 | 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). |
| Secondary | Percentage of Participants Achieving PASI 75 and PASI 90 | 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. |
| Secondary | Percentage of Participants Achieving PASI 100 at Weeks 1, 2, 4, and 16 | 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. |
| Secondary | 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 | 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. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 1, 2, 4, 16, and 26 | 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. |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Weeks 1, 2, 4, 16, and 26 | 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. |
| Secondary | Change From Baseline in EuroQoL-5 Dimensional (EQ-5D) With Psoriasis Bolt-on (EQ-PSO) Score at Weeks 1, 2, 4, 16, and 26 | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline (Week 0) up to end of treatment (Week 26) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04149587
GET https://conductscience.org/api/trials/v1/NCT04149587/registered