Brodalumab in Palmoplantar Psoriasis

Palmoplantar Psoriasis: Evaluating Efficacy and Clinical Photography With Brodalumab in Palmoplantar Psoriasis

NCT04622033•First OC Dermatology

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Consent
•\* Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
•Demographic and Laboratory Assessments
•Adult male or female, at least 18 years old.
•Laboratory values meeting the following criteria prior to the first dose of study drug: Serum aspartate transaminase \< 3 × upper limit of normal (ULN); Serum alanine transaminase 3 2 × ULN; Serum direct bilirubin ≤ 2.0 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome; Total white blood cell count \> 3,000/µL; Absolute neutrophil count \> 1,500/µL; Platelet count \> 100,000/µL; Hemoglobin \> 8 g/dL. (Note: If an exclusionary laboratory result is obtained during the Screening period, one re-test of that particular test is allowed without repeating all other laboratory tests within the 30 day screening window. If the patient has recent laboratory examinations within 3 months, these results can be taken in lieu of screening labs. Subjects who initially do not meet all eligibility criteria for the study may be permitted to repeat the Screening Visit one time following re-consent. )
•Are willing or able to comply with procedures required in this protocol including self-administration of study drug.
•Disease Activity
•Diagnosis of chronic palmoplantar psoriasis by a board certified dermatologist prior to the baseline visit.
•Subject meets the following disease activity criteria: stable palmoplantar psoriasis who are candidates for systemic or phototherapy.
•Contraception
+20 more criteria

Exclusion Criteria

•\- Subject History
•No history of: Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; Active skin disease other than psoriasis that could interfere with the assessment of psoriasis; Chronic infections including human immunodeficiency virus, viral hepatitis (hepatitis B, hepatitis C), and/ or active TB. Subjects with a positive QuantiFERON®-TB /purified protein derivative (tuberculin) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB. If presence of latent TB is established, subjects are not required to be treated with prophylactic anti-TB therapy prior to or during the study, if the subject is considered low risk for reactivation per investigator judgment. Active systemic infection during the last 2 weeks prior to baseline visit (exception: common cold), as assessed by the investigator.
•No history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
•No history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
•No history of underlying medical diseases or problems including but not limited to the following: Subject has been a previous recipient of a solid organ transplant; Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram), or laboratory value at the screening visit outside the given range that, in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data
•No history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
•No major surgery performed within 8 weeks prior to randomization or planned to be performed during the conduct of the trial (e.g., hip replacement, aneurysm removal, stomach ligation) as assessed by the Investigator.
•Concomitant Medications
•No previous exposure to brodalumab.
•No use of any restricted medication as specified in the prohibited medications/therapy section or any drug considered likely to interfere with the safe conduct of the study.
+12 more criteria

Key Dates

Start Date

December 1, 2020

Primary Completion Date

November 30, 2021

Completion Date

May 31, 2022

Last Updated

November 16, 2020

Enrollment

ESTIMATED participants

Conditions

Palmoplantar Psoriasis

Interventions

Brodalumab

BIOLOGICAL

Contacts

Bao Bui, MD

CONTACT

7145312966 baobui.derm@gmail.com

Andrea Nguyen, PA-C

CONTACT

9496799994 andreanguyenpa@gmail.com

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

NCT06042920

Palmoplantar PsoriasisGenital Psoriasis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions