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NCT07477691 · ClinicalTrials.gov registry record · Phase 4
Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
A Phase 4 study, sponsored by BioMarin Pharmaceutical.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT07477691: Recruiting Phase 4 study, sponsored by BioMarin Pharmaceutical.
NCT07477691 is a Phase 4 study that is actively recruiting participants, run by BioMarin Pharmaceutical. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07477691, a Phase 4 study, is actively recruiting participants, sponsored by BioMarin Pharmaceutical.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.
Primary Outcome
To evaluate blood Phe response in adults with PKU co-administered Palynziq with MTX for 6 months
Interventions
- DRUG Methotrexate
- BIOLOGICAL Pegvaliase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-05-29 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 4 |
What NCT07477691 shows while recruiting
NCT07477691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Methotrexate is the first listed.
NCT07477691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07477691 about?
NCT07477691 is a clinical study titled "Immune Modulation During Palynziq® Treatment in Adults (IMPALA)". Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.
What is the current status of trial NCT07477691?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2026-05-29. Estimated completion is 2027-09-30.
What interventions are being tested in trial NCT07477691?
The interventions under investigation include: Methotrexate (DRUG), Pegvaliase (BIOLOGICAL).
Who is sponsoring clinical trial NCT07477691?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07477691's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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