Immune Modulation During Palynziq® Treatment in Adults (IMPALA) (NCT07477691)
A Phase 4 Study of Immune Modulation During Palynziq® Treatment in Adults With Phenylketonuria (PKU)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCLA Dept. of Human Genetics — Los Angeles, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- UCLA Dept. of Human Genetics — Los Angeles, California
- Children's Hospital Colorado — Aurora, Colorado
- University Of South Florida Medical Center — Tampa, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Indiana University School of Medicine — Indianapolis, Indiana
- University of Minnesota Medical School — Minneapolis, Minnesota
- University of Rochester Medical Center (URMC) — Rochester, New York
- Oregon Health & Science University (OHSU) - PARENT — Portland, Oregon
- University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh — Philadelphia, Pennsylvania
- UT Southwestern Medical Center — Dallas, Texas
- University of Utah Hospital — Salt Lake City, Utah
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 983-4587
Email: medinfo@bmrn.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Phenylketonuria
- A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria — Aurora, Colorado
- Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq — Chevy Chase, Maryland
- A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With Phenylketonuria — San Francisco, California
- A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria — Indianapolis, Indiana
- A Study of JNT-517 in Participants With Phenylketonuria (PKU) — Los Angeles, California
Explore by condition: All Phenylketonuria clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.