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Active, not recruitingNCT04658199Updated Aug 3, 2026

A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

A Phase 1 interventional study of UCB0107 (bepranemab) in Progressive Supranuclear Palsy, sponsored by UCB Biopharma SRL. Active, not recruiting at 11 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).

02

Conditions studied

  • Progressive Supranuclear Palsy

Keywords

  • Progressive supranuclear palsy
  • UCB0107
  • Phase 1B study
  • PSP
  • Bepranemab
03

In context

Supranuclear Palsy, Progressive

162 studies on the registry are indexed under Supranuclear Palsy, Progressive; 47 are open to participants now.

This study's enrollment of 19 is below the median of 40 across 95 interventional studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Participant has met a mandatory withdrawal and/or stopping criterion in PSP003 (NCT04185415)
  • Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003 (NCT04185415), or has current suicidal ideation with at least some intent to act as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia Suicide Severity Rating Scale (CSSRS) at the Day 1 Visit. However, participants will not be excluded if, based upon a mental healthcare professional assessment, and the investigator's judgment of benefit/risk, the participant is deemed suitable for receiving study medication
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    UCB0107 (bepranemab)

    Subjects in this study arm will receive Intravenous UCB0107.

    Drug: UCB0107 (bepranemab)

Interventions

  • DrugUCB0107 (bepranemab)

    UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From Baseline of the open-label extension to end of study visit (up to 7 years)

07

Study locations

11 sites
  • Psp002 40122
    Edegem, Belgium
  • Psp002 40002
    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
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04658199
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Dec 8, 2020
Start date
Nov 16, 2020
Primary completion
Dec 13, 2027 (estimated)
Completion
Dec 13, 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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