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Study identifier: NCT07477691 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

Condition: Phenylketonuria  ·  Sponsor: BioMarin Pharmaceutical

PhasePhase 4
Planned participants12
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Specialist  ·  1-800-983-4587  ·  medinfo@bmrn.com

Always discuss trial participation with your own doctor first.

Locations (12)

UCLA Dept. of Human GeneticsLos Angeles, California, United StatesNot Yet Recruiting
Children's Hospital ColoradoAurora, Colorado, United StatesNot Yet Recruiting
University Of South Florida Medical CenterTampa, Florida, United StatesNot Yet Recruiting
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois, United StatesNot Yet Recruiting
Indiana University School of MedicineIndianapolis, Indiana, United StatesNot Yet Recruiting
University of Minnesota Medical SchoolMinneapolis, Minnesota, United StatesNot Yet Recruiting
University of Rochester Medical Center (URMC)Rochester, New York, United StatesNot Yet Recruiting
Oregon Health & Science University (OHSU) - PARENTPortland, Oregon, United StatesNot Yet Recruiting
University of Pittsburgh Medical Center (UPMC) - Children's Hospital of PittsburghPhiladelphia, Pennsylvania, United StatesNot Yet Recruiting
UT Southwestern Medical CenterDallas, Texas, United StatesRecruiting
University of Utah HospitalSalt Lake City, Utah, United StatesNot Yet Recruiting
Children's Hospital of WisconsinMilwaukee, Wisconsin, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07477691