Clinical Trial

Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

Study acronym: PALLADIUM
Active, Not Recruiting Phase 4
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Summary
The purpose of this study is to determine if rapid drug desensitization (RDD) to Palynziq will improve drug tolerability and treatment persistence in adult patients on commercial Palynziq experiencing hypersensitivity reactions (HSRs) leading to treatment interruption or reduction of dose or dosing frequency. See Section 10.8 for full list of HSR preferred terms. Study details include: * Study duration: Up to 30 weeks (up to 6 weeks for Screening, then RDD, and 24 weeks of follow-up) * RDD duration: 1 day * Palynziq dosing/follow-up duration: 24 weeks * Palynziq dosing frequency: Individualized
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-13; most recent amendment 2026-03-30.
Status change: Recruiting → Active, Not Recruiting 2026-03-30
Trial Details
NCT Number NCT06780332
Lead Sponsor BioMarin Pharmaceutical
Conditions Phenylketonuria, PKU
Enrollment 9 participants
Start Date 2025-02-07
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-03