Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

Part of paid clinical trials in Chevy Chase, Maryland.

Sponsor
BioMarin Pharmaceutical
Study ID
NCT06780332
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RDD to Palynziq — DRUG
    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.

Study Details

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

Key Dates

First listed
Jan 17, 2025
Start date
Feb 7, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RDD
    Participants undergoing RDD to Palynziq

Primary Outcome Measure

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). [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Uncommon CuresChevy ChaseMaryland20815-

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Uncommon Cures· Chevy Chase, MD

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