An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

Stopped early · Phase 2

Conditions studied: Parkinson's Disease

In brief

The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.

Key facts

Study ID

NCT05543252

Run by

UCB Biopharma SRL

People needed

428

Starts

2022-08-29

Expected to finish

2025-03-25

Last updated by the study team

2026-04-02

Who can join

Age: 40 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant completed the Treatment Period of PD0053 (NCT04658186). The Baseline Visit for PD0055 (Visit 2) should be no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186). Any delay needs to be justified by the Investigator and approved by the Sponsor
• A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of the IMP and refrain from donating sperm during this period.
• A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of investigational medicinal product (IMP). The study participant must have a negative urine pregnancy test at Screening (Visit 1), which is to be confirmed negative by urine testing prior to the first dose of IMP at PD0055 Baseline Visit. If oral contraception is used, an additional barrier method will be required during the study as an IMP-related gastrointestinal upset or a drug interaction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol.

You may not qualify if…

• Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
• Study participant had previously participated in PD0055
• Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
• Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
• Study participant does not agree to refrain from donating blood or blood products or other body fluids

Where it is running

• Pd0055 40540 — Madrid, Spain
• Pd0055 40542 — Móstoles, Spain
• Pd0055 40352 — Pamplona, Spain
• Pd0055 40541 — San Sebastián, Spain
• Pd0055 40049 — Seville, Spain
• Pd0055 40175 — London, United Kingdom
• Pd0055 40543 — London, United Kingdom
• Pd0055 40698 — London, United Kingdom
• Pd0055 40544 — Motherwell, United Kingdom
• Pd0055 40306 — Newcastle upon Tyne, United Kingdom
• Pd0055 40457 — Plymouth, United Kingdom
• Pd0055 50506 — Phoenix, Arizona, United States
• Pd0055 50519 — Fountain Valley, California, United States
• Pd0055 50385 — Fresno, California, United States
• Pd0055 50118 — Los Angeles, California, United States
• Pd0055 50531 — Englewood, Colorado, United States
• Pd0055 50392 — Danbury, Connecticut, United States
• Pd0055 50538 — Farmington, Connecticut, United States
• Pd0055 50396 — Boca Raton, Florida, United States
• Pd0055 50524 — Bradenton, Florida, United States
• Pd0055 50394 — Tampa, Florida, United States
• Pd0055 50544 — Augusta, Georgia, United States
• Pd0055 50401 — Chicago, Illinois, United States
• Pd0055 50310 — Chicago, Illinois, United States
• Pd0055 40046 — Córdoba, Spain

Full record on ClinicalTrials.gov

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