CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 484 enrolled
Drug / intervention
210 mg brodalumab +2 moredrug
Likely dose
210 mg brodalumabfrom 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/NCT02024646
NCT02024646Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

Bausch Health Americas, Inc.·interventional·Posted Dec 31, 2013·Updated Aug 20, 2020

In Brief

A Phase 3 clinical trial evaluating 210 mg brodalumab, 140 mg brodalumab, and 1 other intervention for Psoriatic Arthritis. Completed, enrolled 484 participants across 103 sites in 10 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesCanada, France, Germany, Greece, Hungary, Latvia, Mexico, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 31, 2013
Enrollment StartMar 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago

Interventions

210 mg brodalumabdrug

210 mg brodalumab administered via subcutaneous injection.

140 mg brodalumabdrug

140 mg brodalumab administered via subcutaneous injection.

Placebodrug

Placebo administered via subcutaneous injection until week 24.