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New treatment option for Phenylketonuria
Official title Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
ClinicalTrials.gov ID: NCT07477691
What this study is testing
What is Pegvaliase?
Pegvaliase is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for phenylketonuria.
Also referred to as Palynziq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults between 18 and 65 years old
- Have a confirmed diagnosis of phenylketonuria (PKU)
- Are in generally good health based on medical evaluation
- Are willing and medically eligible to receive Palynziq and methotrexate (MTX) Cohort A: Have never taken Palynziq before and are willing to start it...
- Agree to use required contraception if they or their partner could become pregnant
You likely can't join if
- Pregnant, breastfeeding, planning to become pregnant, planning to father a child, or not using effective birth control if applicable
- Have a known severe allergy or hypersensitivity reaction to methotrexate (MTX), Palynziq, or other PEG-containing medications
- Have a serious active infection or a history of severe or recurrent infections
- Have significant medical conditions that may affect safety or participation (such as serious heart, lung, liver, kidney, immune, neurological...
- Have a history of substance or alcohol abuse within the past 12 months
- Have had an organ transplant or are taking chronic immunosuppressive medications
See the full eligibility criteria
- Adults between 18 and 65 years old
- Have a confirmed diagnosis of phenylketonuria (PKU)
- Are in generally good health based on medical evaluation
- Are willing and medically eligible to receive Palynziq and methotrexate (MTX) Cohort A: Have never taken Palynziq before and are willing to start it during the study Cohort B: Have blood \> 600 μmol/L after taking...
- Agree to use required contraception if they or their partner could become pregnant
- Are willing to carry two epinephrine devices at all times during Palynziq treatment
- Pregnant, breastfeeding, planning to become pregnant, planning to father a child, or not using effective birth control if applicable
- Have a known severe allergy or hypersensitivity reaction to methotrexate (MTX), Palynziq, or other PEG-containing medications
- Have a serious active infection or a history of severe or recurrent infections
- Have significant medical conditions that may affect safety or participation (such as serious heart, lung, liver, kidney, immune, neurological, psychiatric, or cancer-related conditions)
- Have a history of substance or alcohol abuse within the past 12 months
- Have had an organ transplant or are taking chronic immunosuppressive medications
- Are currently taking medications that are not allowed in the study, including other PKU treatments besides Palynziq
- Are using, or plan to use, injectable PEG-containing medications other than Palynziq during the study
- Have major surgery planned during the study participation period
- Are currently participating in another clinical study involving Palynziq
- In the opinion of the study doctor, are not a suitable candidate for the study or may have difficulty complying with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Minneapolis, Minnesota, United States
- Rochester, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; Minneapolis, Minnesota, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.