Active — Not RecruitingPhase 4

Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

United States9 participantsStarted 2025-02-07

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓.Participants must be 18 years of age or older inclusive, at the time of signing the informed consent.

Exclusion criteria

✕. Participant may not have any kind of disorders that, in the opinion of the investigator, may compromise the ability of the participant to give written informed consent and/or comply with any aspect of the study, and/or where any aspect of participation would be medically inadvisable for the underlying disorder.
✕. Participant must not be pregnant on the day of the RDD.
✕. Participants with uncontrolled asthma, active upper respiratory infection or other active infections, or cardiovascular disease. Asthma control will be assessed using the Asthma Control Test at screening.
✕.Participants receiving beta blockers.

What they're measuring

To determine if RDD to Palynziq improves drug tolerability and treatment persistence in adults with PKU experiencing HSRs leading to treatment interruption or reduction of dose or dosing frequency (reactive HSR).

Timeframe: 24 weeks

Trial details

NCT IDNCT06780332

SponsorBioMarin Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

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