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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05543252
• Other study ID #: PD0055
• Secondary ID: 2022-500424-30-0
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: August 29, 2022
• Est. completion date: December 10, 2029

Study information

• Verified date: June 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 374
• Est. completion date: December 10, 2029
• Est. primary completion date: December 10, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 78 Years

Eligibility

Inclusion Criteria

• 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.

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Minzasolmin (UCB0599)
Minzasolmin (UCB0599) Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive minzasolmin (UCB0599) in a pre-specified sequence during the Treatment Period.

Locations

Country	Name	City	State
Canada	Pd0055 50374	Calgary
Canada	Pd0055 50387	Ottawa
France	Pd0055 40527	Bordeaux
France	Pd0055 40424	Créteil
France	Pd0055 40526	Lille
France	Pd0055 40130	Marseille
France	Pd0055 40635	Nantes
France	Pd0055 40524	Nimes
France	Pd0055 40525	Paris
France	Pd0055 40131	Strasbourg
France	Pd0055 40528	Toulouse Cedex 09
Germany	Pd0055 40515	Berlin
Germany	Pd0055 40138	Bonn
Germany	Pd0055 40530	Dresden
Germany	Pd0055 40711	Erbach
Germany	Pd0055 40023	Erlangen
Germany	Pd0055 40710	Essen
Germany	Pd0055 40532	Haag in Oberbayern
Germany	Pd0055 40249	Kiel
Germany	Pd0055 40174	Mainz
Germany	Pd0055 40529	Marburg
Germany	Pd0055 40531	Regensburg
Italy	Pd0055 40555	Brescia
Italy	Pd0055 40533	Padova
Italy	Pd0055 40257	Roma
Italy	Pd0055 40534	Roma
Italy	Pd0055 40697	Terni
Netherlands	Pd0055 40359	Nijmegen
Poland	Pd0055 40694	Bydgoszcz
Poland	Pd0055 40719	Jelenia Gora
Poland	Pd0055 40539	Katowice
Poland	Pd0055 40538	Krakow
Poland	Pd0055 40696	Krakow
Poland	Pd0055 40700	Lodz
Poland	Pd0055 40702	Lublin
Poland	Pd0055 40535	Oswiecim
Poland	Pd0055 40536	Warszawa
Poland	Pd0055 40699	Warszawa
Poland	Pd0055 40705	Warszawa
Spain	Pd0055 40045	A Coruña
Spain	Pd0055 40159	Barcelona
Spain	Pd0055 40267	Barcelona
Spain	Pd0055 40046	Cordoba
Spain	Pd0055 40540	Madrid
Spain	Pd0055 40542	Móstoles
Spain	Pd0055 40352	Pamplona
Spain	Pd0055 40541	San Sebastián
Spain	Pd0055 40049	Sevilla
United Kingdom	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 States	Pd0055 50544	Augusta	Georgia
United States	Pd0055 50547	Baltimore	Maryland
United States	Pd0055 50396	Boca Raton	Florida
United States	Pd0055 50243	Boston	Massachusetts
United States	Pd0055 50524	Bradenton	Florida
United States	Pd0055 50084	Charleston	South Carolina
United States	Pd0055 50310	Chicago	Illinois
United States	Pd0055 50401	Chicago	Illinois
United States	Pd0055 50311	Cleveland	Ohio
United States	Pd0055 50372	Cleveland	Ohio
United States	Pd0055 50255	Columbus	Ohio
United States	Pd0055 50402	Crab Orchard	West Virginia
United States	Pd0055 50392	Danbury	Connecticut
United States	Pd0055 50531	Englewood	Colorado
United States	Pd0055 50410	Fairfax	Virginia
United States	Pd0055 50538	Farmington	Connecticut
United States	Pd0055 50386	Farmington Hills	Michigan
United States	Pd0055 50519	Fountain Valley	California
United States	Pd0055 50385	Fresno	California
United States	Pd0055 50113	Houston	Texas
United States	Pd0055 50549	Iowa City	Iowa
United States	Pd0055 50074	Kansas City	Kansas
United States	Pd0055 50292	Kirkland	Washington
United States	Pd0055 50397	Las Vegas	Nevada
United States	Pd0055 50121	Lexington	Kentucky
United States	Pd0055 50543	Memphis	Tennessee
United States	Pd0055 50395	New Orleans	Louisiana
United States	Pd0055 50526	Philadelphia	Pennsylvania
United States	Pd0055 50506	Phoenix	Arizona
United States	Pd0055 50536	Saint Paul	Minnesota
United States	Pd0055 50400	San Antonio	Texas
United States	Pd0055 50530	Stony Brook	New York
United States	Pd0055 50394	Tampa	Florida
United States	Pd0055 50398	Tulsa	Oklahoma
United States	Pd0055 50534	Virginia Beach	Virginia
United States	Pd0055 50535	Williamsville	New York
United States	Pd0055 50399	Winfield	Illinois
United States	Pd0055 50546	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 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.	From Baseline up to Month 18
Secondary	Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 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.	From Baseline up to Month 18
Secondary	Incidence of treatment-emergent adverse event (TEAEs)	Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	From Baseline to the Safety Follow-up Visit (Month 31)
Secondary	Incidence of serious adverse events (SAEs)	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.	From Baseline to the Safety Follow-up Visit (Month 31)
Secondary	Incidence of TEAEs leading to withdrawal from study	Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	From Baseline to the Safety Follow-up Visit (Month 31)