CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
Brodalumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03403036
NCT03403036Phase 4Completed

A Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

Icahn School of Medicine at Mount Sinai·interventional·Posted Jan 18, 2018·Updated Mar 10, 2021

In Brief

A Phase 4 clinical trial evaluating Brodalumab for Psoriasis. Completed, enrolled 39 participants across 2 sites.

Detailed Summary

This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label study. Patients will receive 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks. The primary efficacy endpoint will be the proportion of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment. After completion of the 16-week trial, patients may desire to continue treatment with brodalumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 18, 2018
Enrollment StartOct 31, 2017
Primary CompletionAug 18, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.5 years ago

Interventions

Brodalumabdrug

Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.