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

NCT07220915 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-10-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

Panzyga, 10% Intravenous Solution

Panzyga is a 10% Ig formulation for intravenous (IV) administration

OTHER

Placebo

4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220915 on ClinicalTrials.gov