Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Octapharma
Study ID
NCT07220915
Phase
PHASE3
Status
Recruiting
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Conditions

  • Autoimmune Conditions
  • Hypogammaglobulinemia
  • Infections
  • Rheumatic Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panzyga, 10% Intravenous Solution — DRUG
    Panzyga is a 10% Ig formulation for intravenous (IV) administration
  • Placebo — OTHER
    4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion

Study Details

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

Key Dates

First listed
Oct 24, 2025
Start date
Jun 10, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Panzyga 10%
    Panzyga is a 10% Ig formulation for intravenous (IV) administration. The product is delivered as a ready-to-use solution in glass bottles. Patients in the Panzyga treatment arm will receive 0.4 g/kg (4 mL/kg) per single infusion every 4 weeks for up to 48 weeks (up to 13 infusions). In the open-label phase patients will receive Panzyga 0.4 g/kg. If 3-4 weeks after the first open-label infusion the IgG trough level falls below 7 g/L, the dose will be increased to 0.6 g/kg. Additionally, the dose may be increased to 0.6 g/kg if a patient experiences one more major infection, or ≥2 other (non-major) infections.
  • Placebo Comparator: Placebo
    4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion every 4 weeks for up to 48 weeks (up to 13 infusions).

Primary Outcome Measure

Occurrence of Major Infections in Participants [ Time Frame: 48 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Perseverance Research Center, Phoenix Neurological AssociatesScottsdaleArizona85253-

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Perseverance Research Center, Phoenix Neurological Associates· Scottsdale, AZ

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