NCT02613910

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

OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and tolerability information in subjects with pemphigus vulgaris receiving ofatumumab SC every 4 weeks (wk).

Conditions

• Pemphigus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-23
• Primary completion: 2016-03-23
• Completion: 2016-03-23
• First posted: 2015-11-25
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study