Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
← catalyst calendarNCT07477691 · readout in 406 d
Sponsored by BioMarin Pharmaceutical (industry) · BMRN — their whole pipeline →.
Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
12estimated
Sites
12
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-29 | actual | When the study began enrolling |
| Primary completion | 2027-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Phenylketonuria
Interventions
- Biological: Pegvaliase — also filed as Palynziq
- Drug: Methotrexate — also filed as MTX
Primary outcomes
what the primary-completion date above is the date OFChange in blood Phe levels from baseline to Week 25 and Week 49
measured Baseline to Week 25 and Baseline to Week 49
Anti-PEG IgG, IgM, anti-PAL IgG, IgM levels at Weeks 5, 9, 25, and 49
measured Baseline to Week 5, Week 9, Week 25, and Week 49
Permalink · BMRN's whole pipeline · Catalyst calendar · Every registered study · What changed