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Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

NCT04209205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2025-05-16

Study results available
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Summary

The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.

Conditions

Interventions

DRUG

AIN457 6 mg/kg i.v.

AIN457 6 mg/kg delivered by i.v. infusion

DRUG

Placebo

Matching placebo to AIN457 i.v. infusion

DRUG

AIN457 3 mg/kg

AIN457 3 mg/kg delivered by i.v. infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2022-05-17
Completion
2022-05-17
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Greece
  • Guatemala
  • India
  • Malaysia
  • Philippines
  • Poland
  • Russia
  • South Africa
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04209205 on ClinicalTrials.gov