Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03403036|
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Brodalumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies|
|Actual Study Start Date :||October 31, 2017|
|Actual Primary Completion Date :||August 18, 2018|
|Actual Study Completion Date :||August 18, 2018|
Brodalumab (210 mg) via subcutaneous injection using prefilled syringes
Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
- Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1 [ Time Frame: 16 weeks ]
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.
- Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement [ Time Frame: 16 weeks ]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.
- Number of Adverse Events [ Time Frame: 16 weeks ]Number of adverse events as a measure of safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403036
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 70030|
|Principal Investigator:||Mark Lebwohl, MD||Icahn School of Medicine at Mount Sinai|