Can a One-Day allergy fix keep PKU patients on their meds?

NCT ID NCT06780332

Ongoing Disease control Sponsor: BioMarin Pharmaceutical Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a rapid drug desensitization (RDD) protocol for adults with phenylketonuria (PKU) who have had allergic reactions to Palynziq. Over one day, patients receive gradually increasing doses to retrain their immune system. The goal is to see if they can safely restart their regular dose and continue treatment for 24 weeks without severe allergic reactions. Only 9 participants are enrolled, making this a very early test of the approach.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Palynziq (pegvaliase) via rapid drug desensitization protocol
What this could lead to: If successful, this could allow people with PKU who had allergic reactions to safely continue their medication, maintaining disease control without interruption.
What could go wrong: This is a very small study (9 participants) and only tests a single-day desensitization procedure. It may not work for everyone, and allergic reactions could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PHENYLKETONURIA PKU

Contacts and locations

Locations

Uncommon Cures

Chevy Chase, Maryland, 20815, United States

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