An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of UCB0599 in Study Participants With Parkinson's Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UCB0599 High Dose Arm Participants will receive a predefined high dosage of UCB0599 during the Treatment Period. |
Drug: UCB0599
UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
|
| Experimental: UCB0599 Low Dose Arm Participants will receive a predefined low dosage of UCB0599 during the Treatment Period. |
Drug: UCB0599
UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
|
Outcome Measures
Primary Outcome Measures
- Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT)T whole striatum SBR at PD0055 Month 18 [From Baseline up to Month 18]
The change from baseline (screening) in mean striatum specific binding ratios (SBR) will be assessed by Dopamine Transporter Imaging with Single Photon Emission Computed Tomography using 123I-Ioflupane as radiopharmaceutical. Baseline will refer to PD0053 (NCT04658186) Screening Visit date.
Secondary Outcome Measures
- Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18 [From Baseline up to Month 18]
The Cumulative Levodopa Equivalent Daily Dose (LEDD) will be calculated for each participant at each visit and at the end of study. This is the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) should be accounted for when calculating cumulative doses.
- Incidence of treatment-emergent adverse event (TEAEs) [From Baseline to the Safety Follow-up Visit (Month 31)]
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
- Incidence of serious adverse events (SAEs) [From Baseline to the Safety Follow-up Visit (Month 31)]
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Serious criteria of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect . Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
- Incidence of TEAEs leading to withdrawal from study [From Baseline to the Safety Follow-up Visit (Month 31)]
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pd0055 50397 | Las Vegas | Nevada | United States | 89123 |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PD0055
- 2022-500424-30-00
- U1111-1279-2323