Clinical Trial: Immune Modulation During Palynziq(R) Treatment in Adults (IMPALA)

U.S., March 18 -- ClinicalTrials.gov registry received information related to the study (NCT07477691) titled 'Immune Modulation During Palynziq(R) Treatment in Adults (IMPALA)' on March 13.

Brief 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.

Study Start Date: March 31

Study Type: INTERVENTIONAL

Condition: Phenylketonuria

Intervention: BIOLOGICAL: Pegvaliase

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

DRUG: Methotrexate

Oral methotrexate 15 mg administered once weekly during th...