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RecruitingPhase 4NCT07477691

Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

A Phase 4 Study of Immune Modulation During Palynziq® Treatment in Adults With Phenylketonuria (PKU)

Sponsor

BioMarin Pharmaceutical

Enrollment

12 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

Phenylketonuria

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methotrexate and a biological treatment called Pegvaliase for people with phenylketonuria. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPegvaliase

Pegvaliase (Palynziq) administered by subcutaneous injection. Dosing follows U.S. Prescribing Information and investigator judgement.

DRUGMethotrexate

Oral methotrexate 15 mg administered once weekly during the Tolerability Period and the Combination Treatment Period.

Locations(12)

UCLA Dept. of Human Genetics

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University Of South Florida Medical Center

Tampa, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Minnesota Medical School

Minneapolis, Minnesota, United States

University of Rochester Medical Center (URMC)

Rochester, New York, United States

Oregon Health & Science University (OHSU) - PARENT

Portland, Oregon, United States

University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

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NCT07477691

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