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

Phase 2

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: Minzasolmin (UCB0599)

• Registration Number: NCT05543252
• Lead Sponsor: UCB Biopharma SRL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-29
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Primary Completion: 2025-03-18
• Study Completion: 2025-03-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

Not provided

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)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minzasolmin (UCB0599) Low Dose Arm	Minzasolmin (UCB0599)	Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
Minzasolmin (UCB0599) High Dose Arm	Minzasolmin (UCB0599)	Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.

Primary Outcome Measures

Name	Time	Method
Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) 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

Name	Time	Method
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.
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.

Trial Locations

Locations (96)

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

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