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Clinical Trial Summary

This is a Phase 4 single center, single-arm, open-label study that will evaluate the efficacy and safety of brodalumab in psoriasis patients as well as the impact on quality of life in addition to clinical photography. Efficacy will be evaluated by a study treatment assessor. The study includes a 30-day screening period with study visits at Week 0, 2, 4, 8, 12, 16, and 24. Study drug dosing will consist of patients self-injecting according to on-label FDA approved dosing of brodalumab 210mg at week 0, 1, 2 and then every 2 weeks thereafter for moderate to severe psoriasis patients after adequate injection training is given at study center site. Subjects will be instructed at Week 0 (pre-injection) by the site staff on how to self-inject via the dosing syringe. Study drug will be dispensed through the delineated REMS approved pharmacy. Baseline assessment will be performed at week 0 and efficacy assessments will be performed at week 4, 8, 12, 16 and 24, then every 2 weeks thereafter for palmoplantar psoriasis using approved dosing schedule for moderate to severe psoriasis. Patients will self inject after adequate injection training is given at the study center site.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04622033
Study type Interventional
Source First OC Dermatology
Contact Bao Bui, MD
Phone 7145312966
Email baobui.derm@gmail.com
Status Not yet recruiting
Phase Phase 4
Start date December 1, 2020
Completion date May 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06042920 - A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis Phase 4
Completed NCT04720105 - Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis Phase 4
Completed NCT01197976 - Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis Phase 2
Completed NCT00629772 - Safety and Efficacy of Infliximab in Palmoplantar Psoriasis Phase 3