Trials / Not Yet Recruiting
Not Yet RecruitingNCT07220915
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")
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2025-10-24
- Last updated
- 2025-10-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07220915. Inclusion in this directory is not an endorsement.