Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 15, 2018

Primary Completion Date

August 26, 2020

Study Completion Date

August 26, 2021

Conditions
Polymyalgia Rheumatica
Interventions
DRUG

Sirukumab

Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukumab, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug

DRUG

Placebo to match sirukumab

Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug

DRUG

Prednisone /Prednisone placebo

Prednisone will be provided as tablets with dosage level up to 20 mg/day. All subjects will receive 20 mg prednisone at Baseline (Randomization) and follow predefined taper regimen (6 weeks or 52 weeks) based on treatment assignment. Placebo to match prednisone will be provided as tablets

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02899026 - Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica | Biotech Hunter | Biotech Hunter