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

• Status: Enrolling by invitation
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL

Criteria

Inclusion Criteria

• Participant completed the Treatment Period of PD0053 (NCT04658186). The Baseline Visit for PD0055 (Visit 2) needs to be within 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186)

• 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.

Exclusion Criteria:

• 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)