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Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

NCT06780332 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

RDD to Palynziq

Delivery of gradually increasing doses of Palynziq at fixed time intervals over the course of several hours to a cumulative dose equal to the reactive dose. Reactive dose is defined as the dose at which the reactive HSR occurred which led to treatment interruption or reduction of dose or dose frequency.

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · BioMarin Pharmaceutical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT06780332 on ClinicalTrials.gov