Panzyga for Preventing Infections in Autoimmune Conditions
This study is testing if Panzyga, an intravenous (IV) solution, can help prevent serious infections in people with autoimmune or rheumatic conditions (like rheumatoid arthritis or lupus) who also have hypogammaglobulinemia (a weak immune system). Participants will receive either Panzyga or a placebo (a salt water solution) through an IV. The main goal is to see how many major infections occur in each group over 48 weeks. You may be able to join if you are at least 18 years old, have an autoimmune or rheumatic condition, and are receiving B-cell depletion therapy. The study is currently recruiting 360 participants.
- Study design
- This is a Phase 3, randomized, double-blind, placebo-controlled study involving 360 participants across multiple locations.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for the occurrence of major infections for 48 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Occurrence of Major Infections in Participants48 weeks
Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and/or viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.