Minzasolmin for Parkinson's Disease

Recruiting at 97 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UCB Biopharma SRL

Disqualifiers: Pregnancy, Breastfeeding, Implantable devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

428 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

This trial is for people with early-stage Parkinson's disease who completed a prior study (PD0053) and can start this one within 4 weeks of the last. Participants must agree to contraception use and not plan pregnancy or sperm donation during and after the trial. They should be able to consent and follow study rules.

Inclusion Criteria

Participant completed the Treatment Period of PD0053 (NCT04658186) with the Baseline Visit for PD0055 (Visit 2) no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186), with any delay justified by the Investigator and approved by the Sponsor

I am not pregnant or breastfeeding and agree to use contraception during and for 1 month after treatment.

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 participants wearing any kind of implantable active device will be excluded from using Digital Health Technology but may participate in the main study

Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or compromise the study participant's ability to participate

Study participant had previously participated in PD0055

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high or low dose of minzasolmin (UCB0599) to evaluate its long-term efficacy, safety, and tolerability

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 months

Open-label extension

Participants may continue to receive the study drug to further assess long-term effects

Long-term

Treatment Details

Interventions

• UCB0599

Trial Overview The trial tests long-term effects of Minzasolmin (UCB0599) on brain function in Parkinson's patients, comparing those who start treatment early versus those who begin later. It aims to understand how the drug influences disease progression over time.

Participant Groups

Group I: Minzasolmin (UCB0599) Low Dose Arm Experimental Treatment 1 Intervention

Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.

Group II: Minzasolmin (UCB0599) High Dose Arm Experimental Treatment 1 Intervention

Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven