NCT01364389

A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica

A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess Safety and Long Term Efficacy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1. Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.

Conditions

• Polymyalgia Rheumatica
• Inflammatory Diseases

Interventions

Type	Name	Description
DRUG	AIN457	3 mg/kg
DRUG	ACZ885	3 mg/kg
DRUG	Prednisone	20 mg
DRUG	Placebo	Matching placebo to AIN457, ACZ885 and prednisone

Timeline

• Start date: 2011-02-14
• Primary completion: 2013-01-29
• Completion: 2013-01-29
• First posted: 2011-06-02
• Last updated: 2021-09-17
• Results posted: 2015-03-04

Locations

6 sites across 4 countries: United States, Germany, Italy, United Kingdom