Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1304-3004 | Other Identifier | Universal Trial Number (UTN) | |
| 2024-510951-36 | Registry Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0107 (bepranemab) | Experimental | Subjects in this study arm will receive Intravenous UCB0107. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0107 (bepranemab) | Drug | UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). | From Baseline of the open-label extension to end of study visit (up to 7 years) |
Not provided
Not provided
Inclusion Criteria:
Participant meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Hoeglinger et al, 2017)
Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 (NCT04185415)
Participant can be male or female
a) A male participant must agree to use contraception as detailed in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: I. Not a woman of childbearing potential (WOCBP) OR II. A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment.
Participant (or legal representative, as applicable and acceptable by local regulations) is giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent must be obtained before initiating any study procedures
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psp002 40122 | Edegem | Belgium | ||||
| Psp002 40002 |
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Leuven |
| Belgium |
| Psp002 40277 | Bochum | Germany |
| Psp002 40276 | Düsseldorf | Germany |
| Psp002 40278 | Essen | Germany |
| Psp002 40024 | Hanover | Germany |
| Psp002 40267 | Barcelona | Spain |
| Psp002 40100 | Madrid | Spain |
| Psp002 40268 | Pamplona | Spain |
| Psp002 40175 | London | United Kingdom |
| Psp002 40165 | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided