RecruitingPhase 3NCT07220915

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

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")


Sponsor

Octapharma

Enrollment

360 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Panzyga, 10% Intravenous Solution and Placebo for people with autoimmune conditions, hypogammaglobulinemia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(6)

Perseverance Research Center, Phoenix Neurological Associates

Scottsdale, Arizona, United States

UMHAT Sveti Georgi EAD

Plovdiv, Bulgaria

P. Stradins Clinical University Hospital

Riga, Latvia

Riga East Clinical University Hospital

Riga, Latvia

Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos

Kaunas, Lithuania

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, Poland

View Full Details on ClinicalTrials.gov

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NCT07220915


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