Conditions: Pemphigus
Keywords: Ofatumumab Pemphigus Vulgaris Long-Term Extension Study
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: t the Baseline (Bln) and wk 4 visits, Subjects will receive 40mg ofatumumab sc (Oft) (as two 20mg sc inj) and as 1 Oft 20mg sc inj every 4 wks from wk 8 through wk 56. Subjects will return to clinic 4 wks after the last dose for a follow-up (f/u) visit (wk 60). Antihistamine 10 mg and Acetaminophen/paracetamol (A/P) 1 grams(g) will be given 1-2 hours(h) before and 4 h after each dose of Oft. A/P 1 g will be supplied for self administration if needed. Prednisone/Prednisolone dose will continue to be tapered during core study period (CSP) by 1 dose level every 2 wks to \<= 10 mg/day from Bln through wk 60. Upon completion of the CSP, subjects will enter Individualized f/u Period, where subjects will monitored every 12 wks for a minimum of 1 yr and for up to 2 yr, until CD19+ B-LC or IgG recover to lower limit of normal (LLN) or to the subject's Bln value from Study OPV116910 (if \<LLN) or if study withdrawal criteria are met or for a maximum of 2 yr after the last dose of Oft.

Interventions: intervention 1: Ofatumumab intervention 2: Acetaminophen/paracetamol intervention 3: Antihistamine (cetirizine or equivalent) intervention 4: Prednisone/Prednisolone
Intervention descriptions: intervention 1: 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 intervention 2: Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration intervention 3: Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration intervention 4: 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

Protocol document: