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

Part of paid clinical trials in Avondale, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05767034
Phase
PHASE3
Status
Completed

Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 300 mg — DRUG
    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
  • Secukinumab 150 mg — DRUG
    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
  • Placebo to secukinumab — OTHER
    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Study Details

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.

Key Dates

Start date
Mar 22, 2023
Status verified
Mar 2026
Primary completion
Sep 10, 2025
Completion
Feb 16, 2026

Study Design

Enrollment
381 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 300 mg
    randomized in 1:1:1 ratio every 4 weeks
  • Experimental: Secukinumab 150 mg
    randomized in 1:1:1 ratio every 4 weeks
  • Placebo Comparator: Placebo to secukinumab
    randomized in 1:1:1 ratio every 4 weeks

Primary Outcome Measure

Proportion of participants achieving sustained remission [ Time Frame: at Week 52 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology Associates PLLCAvondaleArizona85392-
Sun Valley Arthritis Center LtdPeoriaArizona85381-
AZ Arthritis and Rheumtlgy Rsh PLLCPhoenixArizona85032-
Precn Comprehensive Clnl Rsch SolnsSan LeandroCalifornia94578-
Providence Saint Johns Health CtrSanta MonicaCalifornia90404-
Center for Rheumatology ResearchWest HillsCalifornia91307-
Millennium Clinical TrialsWestlake VillageCalifornia91361-
Rheumatology Associates of South FloridaBoca RatonFlorida33486-
UF Health Cancer CenterGainesvilleFlorida32610-
Sarasota Arthritis Res CtrSarasotaFlorida34239-
West Broward Rheumatology Associates IncTamaracFlorida33321-
Southeastern Rheumatology AllianceGainesvilleGeorgia30501-
Klein and AssociatesHagerstownMaryland21740-
Massachusetts General HospitalBostonMassachusetts02114-
Clinical Research Inst of MISaint Clair ShoresMichigan48081-
Kansas City Physician PartnersKansas CityMissouri64111-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Paramount Med Rsrch and Consult LLCMiddleburg HeightsOhio44130-
DM Clinical ResearchHoustonTexas77070-
Prolato Clinical Research CenterHoustonTexas77054-
Accurate Clinical Research IncSan AntonioTexas78229-
Advanced Rheumatology of HoustonSpringTexas77382-

Related coverage on Hipa.ai

Find similar trials in Avondale, AZ

By research site
Arizona Arthritis and Rheumatology Associates PLLC· Avondale, AZSun Valley Arthritis Center Ltd· Peoria, AZAZ Arthritis and Rheumtlgy Rsh PLLC· Phoenix, AZPrecn Comprehensive Clnl Rsch Solns· San Leandro, CAProvidence Saint Johns Health Ctr· Santa Monica, CACenter for Rheumatology Research· West Hills, CA

Related Studies