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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06780332
The ClinicalTrials.gov registry entry for NCT06780332 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 12 other Phenylketonuria trials with a reported enrollment target (90% lower). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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