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Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

NCT05767034 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2026-03-09

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

Conditions

  • Polymyalgia Rheumatica

Interventions

DRUG

Secukinumab 300 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

DRUG

Secukinumab 150 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

OTHER

Placebo to secukinumab

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2025-09-10
Completion
2026-02-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Mexico
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT05767034 on ClinicalTrials.gov