Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

December 23, 2015

Primary Completion Date

March 23, 2016

Study Completion Date

March 23, 2016

Conditions
Pemphigus
Interventions
DRUG

Ofatumumab

Ofatumumab (human monoclonal antibody) will be provided as a liquid concentrate in a prefilled glass syringe with staked needle, stopper, and plunger containing 0.4 millilitre (mL) (20 mg) drug product of 50 mg/mL concentration

DRUG

Acetaminophen/paracetamol

Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration

DRUG

Antihistamine (cetirizine or equivalent)

Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration

DRUG

Prednisone/Prednisolone

Prednisone/Prednisolone will be supplied from the dose range 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 25, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180, 200, 220 and 240 mg for oral administration

Trial Locations (2)

48103

GSK Investigational Site, Ann Arbor

90045

GSK Investigational Site, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY