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Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

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ClinicalTrials.gov Identifier: NCT03403036
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Lebwohl, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Brodalumab
Enrollment 39
Recruitment Details 41 patients screened with 39 meeting all eligibility requirements. Patients with moderate-to-severe psoriasis were recruited from 3 sites.
Pre-assignment Details  
Arm/Group Title Brodalumab
Hide Arm/Group Description Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Period Title: Overall Study
Started 39
Completed 34
Not Completed 5
Reason Not Completed
Lack of Efficacy             5
Arm/Group Title Brodalumab
Hide Arm/Group Description Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
50.74  (2.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
14
  35.9%
Male
25
  64.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Baseline PASI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 39 participants
20.36  (2.24)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) - combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). Higher score indicates more severe psoriasis.
Baseline sPGA   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 39 participants
3.41  (0.08)
[1]
Measure Description: static Physician’s Global Assessment (sPGA) is a 6-point numerical scale ranging from 0 (clear) to 5 (very severe) to assess psoriasis severity at a given time point .
Number of participants who failed Secukinumab  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
16
  41.0%
Number of participants who failed Ixekizumab  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
19
  48.7%
Number of participants who failed both Secukinumab and Ixekizumab  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
4
  10.3%
Number of previously failed biologics   [1] 
Mean (Standard Deviation)
Unit of measure:  Biologic medications
Number Analyzed 39 participants
2.23  (0.29)
[1]
Measure Description: The average number of total failed biologic agents per patient
1.Primary Outcome
Title Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1
Hide Description

Number of patients achieving a score of “0-clear” or “1-almost clear” in the sPGA score after 16 weeks of treatment to measure efficacy.

Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brodalumab
Hide Arm/Group Description:
Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
24
  70.6%
2.Secondary Outcome
Title Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement
Hide Description PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Number of participants with 75%, 90%, and 100% reduction in the PASI score, respectively, PASI-75, PASI-90, and PASI-100 who completed the trial at week 16.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brodalumab
Hide Arm/Group Description:
Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
PASI-75
26
  76.5%
PASI-90
17
  50.0%
PASI-100
11
  32.4%
3.Secondary Outcome
Title Number of Adverse Events
Hide Description Number of adverse events as a measure of safety
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brodalumab
Hide Arm/Group Description:
Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: events
6
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brodalumab
Hide Arm/Group Description Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
All-Cause Mortality
Brodalumab
Affected / at Risk (%)
Total   0/39 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Brodalumab
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brodalumab
Affected / at Risk (%) # Events
Total   6/39 (15.38%)    
Endocrine disorders   
Pre-Diabetes   1/39 (2.56%)  1
Eye disorders   
Corneal Ulcer   1/39 (2.56%)  1
Immune system disorders   
Allergic Sinusitis   1/39 (2.56%)  1
Infections and infestations   
Tooth Abscess   1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders   
Sciatica   1/39 (2.56%)  1
Skin and subcutaneous tissue disorders   
Folliculitis   1/39 (2.56%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Lebwohl
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
EMail: mark.lebwohl@mountsinai.org
Layout table for additonal information
Responsible Party: Mark Lebwohl, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03403036     History of Changes
Other Study ID Numbers: GCO 17-1581
First Submitted: January 11, 2018
First Posted: January 18, 2018
Results First Submitted: June 18, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019