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NCT06780332 · ClinicalTrials.gov registry record · Phase 4
Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq
A Phase 4 study of Phenylketonuria and PKU, sponsored by BioMarin Pharmaceutical.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06780332: Recruiting Phase 4 study of Phenylketonuria and PKU, sponsored by BioMarin Pharmaceutical.
NCT06780332 is a Phase 4 study of Phenylketonuria and PKU that is actively recruiting participants, run by BioMarin Pharmaceutical. The registered enrollment target is 10 participants, below the 98-participant average among 12 other Phenylketonuria trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06780332, a Phase 4 study of Phenylketonuria and PKU, is actively recruiting participants, sponsored by BioMarin Pharmaceutical.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Tolerance, defined as the ability to restart Palynziq at the dose at which the reactive HSR occurred (reactive dose) and escalate as appropriate within 24 weeks following the RDD, without requiring treatment interruption or reduction of dose or dosing frequency due to HSRs and reduction in occurrence of HSRs Grade 2 or above within 24 weeks following RDD
Conditions Studied
Interventions
- DRUG RDD to Palynziq
Study Locations (1)
Maryland
- Uncommon Cures - Chevy Chase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-01 |
| Est. Completion | 2025-11 |
| Phase | Phase 4 |
What NCT06780332 shows while recruiting
NCT06780332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 98-participant average among 12 other Phenylketonuria trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Phenylketonuria appearing as the primary indexed condition, and to 1 intervention - of which RDD to Palynziq is the first listed.
NCT06780332 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06780332 about?
NCT06780332 is a clinical study titled "Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq". 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 ...
What is the current status of trial NCT06780332?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2025-01. Estimated completion is 2025-11.
What conditions does trial NCT06780332 study?
This clinical trial studies the following conditions: Phenylketonuria, PKU.
What interventions are being tested in trial NCT06780332?
The interventions under investigation include: RDD to Palynziq (DRUG).
Who is sponsoring clinical trial NCT06780332?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06780332 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06780332's enrollment target sits among peer trials
10 12th of 12 higher than 1 of 12 other Phenylketonuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phenylketonuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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