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Brodalumab in Palmoplantar Psoriasis

NCT04622033 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-11-16

No results posted yet for this study

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.

Conditions

  • Palmoplantar Psoriasis

Interventions

BIOLOGICAL

Brodalumab

brodalumab 210mg at week 0, 1, 2 and then every 2 weeks up to 24 weeks.

Sponsors & Collaborators

  • First OC Dermatology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-11-30
Completion
2022-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622033 on ClinicalTrials.gov