MedTrace Logo

Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

NCT02024646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2020-08-20

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

210 mg brodalumab

210 mg brodalumab administered via subcutaneous injection.

DRUG

140 mg brodalumab

140 mg brodalumab administered via subcutaneous injection.

DRUG

Placebo

Placebo administered via subcutaneous injection until week 24.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02024646 on ClinicalTrials.gov