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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500424-30-00 | Registry Identifier | EU CT Number | |
| U1111-1279-2323 | Other Identifier | Universal Trial Number (UTN) |
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Based on available data, the decision was made to stop development of UCB0599/minzasolmin as treatment of Parkinson's Disease.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minzasolmin (UCB0599) High Dose Arm | Experimental | Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period. |
|
| Minzasolmin (UCB0599) Low Dose Arm | Experimental | Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minzasolmin (UCB0599) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dopamine Transporter Imaging, Measured by Single Photon Emission Computed Tomography (DaT-SPECT), Whole Striatum Specific Binding Ratio up to PD0055 EOT or ET (Corresponding to a Visit Between PD0055 Month 6 and Month 18 Inclusive) | Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit. | From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 Screening |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18 | The Cumulative Levodopa Equivalent Daily Dose (LEDD) was calculated for each participant at each visit, based on the dose level and frequency indicated on the concomitant medication form and at the end of study. This was the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) were accounted for when calculating cumulative doses. |
Not provided
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:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pd0055 50506 | Phoenix | Arizona | 85004-1150 | United States | ||
| Pd0055 50519 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Participant Flow refers to the Safety Set.
The study started to enroll participants in August 2022 and concluded in March 2025.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Delayed-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 end of treatment (EOT)/early termination (ET) visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2024 | Jan 19, 2026 |
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| From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 Screening |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place. | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
| Percentage of Participants With Serious TEAEs | A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, and other important medical events which are based on medical or scientific judgement may jeopardise the participant's life, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place. | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
| Percentage of Participants With TEAEs Leading to Withdrawal From the Study | Percentage of participants with TEAEs leading to withdrawal from the study are presented. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place. | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Pd0055 50385 | Fresno | California | 93710 | United States |
| Pd0055 50118 | Los Angeles | California | 90033 | United States |
| Pd0055 50531 | Englewood | Colorado | 80113 | United States |
| Pd0055 50392 | Danbury | Connecticut | 06810 | United States |
| Pd0055 50538 | Farmington | Connecticut | 06030-3805 | United States |
| Pd0055 50396 | Boca Raton | Florida | 33486 | United States |
| Pd0055 50524 | Bradenton | Florida | 34205 | United States |
| Pd0055 50394 | Tampa | Florida | 33613 | United States |
| Pd0055 50544 | Augusta | Georgia | 30912-0004 | United States |
| Pd0055 50401 | Chicago | Illinois | 60611 | United States |
| Pd0055 50310 | Chicago | Illinois | 60612-3863 | United States |
| Pd0055 50399 | Winfield | Illinois | 60190 | United States |
| Pd0055 50549 | Iowa City | Iowa | 52242 | United States |
| Pd0055 50074 | Kansas City | Kansas | 66160-8500 | United States |
| Pd0055 50121 | Lexington | Kentucky | 40536-0284 | United States |
| Pd0055 50395 | New Orleans | Louisiana | 70121 | United States |
| Pd0055 50547 | Baltimore | Maryland | 21287 | United States |
| Pd0055 50243 | Boston | Massachusetts | 02114 | United States |
| Pd0055 50546 | Worcester | Massachusetts | 01655 | United States |
| Pd0055 50386 | Farmington Hills | Michigan | 48334 | United States |
| Pd0055 50536 | Saint Paul | Minnesota | 55130 | United States |
| Pd0055 50397 | Las Vegas | Nevada | 89123 | United States |
| Pd0055 50530 | Stony Brook | New York | 11794 | United States |
| Pd0055 50535 | Williamsville | New York | 14221 | United States |
| Pd0055 50372 | Cleveland | Ohio | 44121 | United States |
| Pd0055 50311 | Cleveland | Ohio | 44195 | United States |
| Pd0055 50255 | Columbus | Ohio | 43210-1240 | United States |
| Pd0055 50398 | Tulsa | Oklahoma | 74136 | United States |
| Pd0055 50084 | Charleston | Oregon | 29425 | United States |
| Pd0055 50526 | Philadelphia | Pennsylvania | 19107 | United States |
| Pd0055 50543 | Memphis | Tennessee | 38157 | United States |
| Pd0055 50113 | Houston | Texas | 77030 | United States |
| Pd0055 50525 | Houston | Texas | 77030 | United States |
| Pd0055 50400 | San Antonio | Texas | 78229-3900 | United States |
| Pd0055 50107 | Burlington | Vermont | 05401 | United States |
| Pd0055 50410 | Fairfax | Virginia | 22031 | United States |
| Pd0055 50534 | Virginia Beach | Virginia | 23456 | United States |
| Pd0055 50292 | Kirkland | Washington | 98034 | United States |
| Pd0055 50402 | Crab Orchard | West Virginia | 25827 | United States |
| Pd0055 50374 | Calgary | Canada |
| Pd0055 50387 | Ottawa | Canada |
| Pd0055 50389 | Toronto | Canada |
| Pd0055 40527 | Bordeaux | France |
| Pd0055 40424 | Créteil | France |
| Pd0055 40526 | Lille | France |
| Pd0055 40130 | Marseille | France |
| Pd0055 40635 | Nantes | France |
| Pd0055 40524 | Nîmes | France |
| Pd0055 40525 | Paris | France |
| Pd0055 40131 | Strasbourg | France |
| Pd0055 40528 | Toulouse | France |
| Pd0055 40515 | Berlin | Germany |
| Pd0055 40138 | Bonn | Germany |
| Pd0055 40530 | Dresden | Germany |
| Pd0055 40711 | Erbach im Odenwald | 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 | Germany |
| Pd0055 40555 | Brescia | Italy |
| Pd0055 40533 | Padova | Italy |
| Pd0055 40257 | Roma | Italy |
| Pd0055 40534 | Roma | Italy |
| Pd0055 40697 | Terni | Italy |
| Pd0055 40359 | Nijmegen | Netherlands |
| Pd0055 40694 | Bydgoszcz | Poland |
| Pd0055 40719 | Jelenia Góra | Poland |
| Pd0055 40539 | Katowice | Poland |
| Pd0055 40538 | Krakow | Poland |
| Pd0055 40696 | Krakow | Poland |
| Pd0055 40700 | Lodz | Poland |
| Pd0055 40702 | Lublin | Poland |
| Pd0055 40535 | Oświęcim | Poland |
| Pd0055 40536 | Warsaw | Poland |
| Pd0055 40699 | Warsaw | Poland |
| Pd0055 40705 | Warsaw | Poland |
| Pd0055 40045 | A Coruña | Spain |
| Pd0055 40159 | Barcelona | Spain |
| Pd0055 40267 | Barcelona | Spain |
| Pd0055 40046 | Córdoba | Spain |
| Pd0055 40540 | Madrid | Spain |
| Pd0055 40542 | Móstoles | Spain |
| Pd0055 40352 | Pamplona | Spain |
| Pd0055 40541 | San Sebastián | Spain |
| Pd0055 40049 | Seville | Spain |
| 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 Kingdom |
| FG001 | Early-start Minzasolmin (UCB0599) 180 mg/Day | Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| FG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Delayed-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| BG001 | Early-start Minzasolmin (UCB0599) 180 mg/Day | Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| BG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Dopamine Transporter Imaging, Measured by Single Photon Emission Computed Tomography (DaT-SPECT), Whole Striatum Specific Binding Ratio up to PD0055 EOT or ET (Corresponding to a Visit Between PD0055 Month 6 and Month 18 Inclusive) | Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit. | Full Analysis Set (FAS) included all study participants who were randomized into PD0053, who signed the informed consent form (ICF) for PD0055, who received at least a partial dose of PD0055 IMP, and had at least 1 assessment post PD0055 Baseline. This analysis set excluded participants who did not meet PD0053 key inclusion/exclusion criteria. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | specific binding ratio | From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 Screening |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18 | The Cumulative Levodopa Equivalent Daily Dose (LEDD) was calculated for each participant at each visit, based on the dose level and frequency indicated on the concomitant medication form and at the end of study. This was the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) were accounted for when calculating cumulative doses. | FAS included all study participants who were randomized into PD0053, who signed the informed consent form (ICF) for PD0055, who received at least a partial dose of PD0055 IMP, and had at least 1 assessment post PD0055 Baseline. This analysis set excluded participants who did not meet PD0053 key inclusion/exclusion criteria. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligrams | From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 Screening |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place. | Safety Set (SS) included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 investigational medicinal product (IMP). | Posted | Number | percentage of participants | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serious TEAEs | A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, and other important medical events which are based on medical or scientific judgement may jeopardise the participant's life, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place. | SS included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP. | Posted | Number | percentage of participants | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TEAEs Leading to Withdrawal From the Study | Percentage of participants with TEAEs leading to withdrawal from the study are presented. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place. | SS included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP. | Posted | Number | percentage of participants | From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31) |
|
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. | 1 | 153 | 7 | 153 | 70 | 153 |
| EG001 | Early-start Minzasolmin (UCB0599) 180 mg/Day | Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. | 0 | 136 | 9 | 136 | 56 | 136 |
| EG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. | 0 | 139 | 10 | 139 | 42 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Prostatectomy | Surgical and medical procedures | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
Study PD0055 was terminated early, as the decision was made to stop development of UCB0599/minzasolmin as treatment of Parkinson's Disease.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2025 | Jan 16, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| 65 to <85 years |
|
| >= 85 years |
|
| Male |
|
| White |
|
| Other/mixed |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Missing |
|
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
| OG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
|
|
| OG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
|
|
| OG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
|
|
| OG002 | Early-start Minzasolmin (UCB0599) 360 mg/Day | Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit. |
|
|