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...