Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that is actively recruiting participants, run by BioMarin Pharmaceutical. The registered enrollment target is 12 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07477691
The ClinicalTrials.gov registry entry for NCT07477691 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methotrexate is the first listed.
NCT07477691 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.