Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
Public ClinicalTrials.gov record NCT07477691. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Study of Immune Modulation During Palynziq® Treatment in Adults With Phenylketonuria (PKU)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07477691
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2026
- Primary completion
- Sep 29, 2027
- Completion
- Sep 29, 2027
- Last update posted
- Jun 16, 2026
2026 – 2027
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Dept. of Human Genetics | Los Angeles | California | 90095 | Not yet recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Not yet recruiting |
| University Of South Florida Medical Center | Tampa | Florida | 33613 | Not yet recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Not yet recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Not yet recruiting |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | Not yet recruiting |
| University of Rochester Medical Center (URMC) | Rochester | New York | 14642 | Not yet recruiting |
| Oregon Health & Science University (OHSU) - PARENT | Portland | Oregon | 97239 | Not yet recruiting |
| University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| University of Utah Hospital | Salt Lake City | Utah | 84108 | Not yet recruiting |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07477691, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07477691 live on ClinicalTrials.gov.