A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 8, 2015

Primary Completion Date

January 16, 2018

Study Completion Date

August 13, 2018

Conditions
Primary Sjögren's Syndrome
Interventions
BIOLOGICAL

AMG 557/MEDI5872

Participants will receive a fixed SC dose of 210 mg MEDI5872 (AMG 557/MEDI5872) QW for 3 weeks (Days 1 to 15) and then Q2W for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, all participants from double-blind period will receive a fixed SC dose of 210 mg MEDI5872 from Day 99 to Day 183 (QW from Days 99 to 113 for participants from Placebo arm and on Days 99 and 113 for participants from MEDI5872 210 mg arm; and Q2W from Days 127 to 183 for participants from both arms).

OTHER

Placebo

The SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, an additional dose of blinded placebo will be administered on Day 106 for participants who will receive MEDI5872 210mg in double-blinded period.

Trial Locations (13)

15213

Research Site, Pittsburgh

29609

Research Site, Brest

59037

Research Site, Lille

67098

Research Site, Strasbourg

75651

Research Site, Paris

75679

Research Site, Paris

94143

Research Site, San Francisco

94275

Research Site, Le Kremlin-Bicêtre

20892-1190

Research Site, Bethesda

Unknown

Research Site, Stockholm

EC1M 6BQ

Research Site, London

NE2 4HH

Research Site, Newcastle upon Tyne

SN3 6BB

Research Site, Swindon

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

MedImmune LLC

INDUSTRY