A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 30, 2019

Primary Completion Date

June 8, 2021

Study Completion Date

June 8, 2021

Conditions
Giant Cell Arteritis
Interventions
DRUG

Secukinumab 300 mg, s.c.

Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.

DRUG

Prednisolone

Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose)

DRUG

Placebo

Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.

Trial Locations (11)

13125

Novartis Investigative Site, Berlin

23538

Novartis Investigative Site, Lübeck

44649

Novartis Investigative Site, Herne

50937

Novartis Investigative Site, Cologne

54292

Novartis Investigative Site, Trier

67063

Novartis Investigative Site, Ludwigshafen

79106

Novartis Investigative Site, Freiburg im Breisgau

82110

Novartis Investigative Site, Germering

91054

Novartis Investigative Site, Erlangen

97080

Novartis Investigative Site, Würzburg

01067

Novartis Investigative Site, Dresden

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY