A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy ("PROTECT")
Octapharma
Summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients who meet all of the following criteria will be eligible to participate in the study: 1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune c…
Interventions
- DrugPanzyga, 10% Intravenous Solution
Panzyga is a 10% Ig formulation for intravenous (IV) administration
- OtherPlacebo
4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion
Location
- Perseverance Research Center, Phoenix Neurological AssociatesScottsdale, Arizona