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NCT03010527 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
A Phase 2 study of Chronic Plaque Psoriasis, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
- 20
- Study locations
NCT03010527: Completed Phase 2 study of Chronic Plaque Psoriasis, sponsored by UCB Biopharma SRL.
NCT03010527 is a Phase 2 study of Chronic Plaque Psoriasis that has completed, run by UCB Biopharma SRL. The registered enrollment target is 217 participants, below the 1,096-participant average among 6 other Chronic Plaque Psoriasis trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03010527, a Phase 2 study of Chronic Plaque Psoriasis, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
Primary Outcome
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experienci
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bimekizumab
Study Locations (20)
Other
- Ps0011 209 - Edmonton
- Ps0011 201 - North Bay
- Ps0011 206 - Peterborough
- Ps0011 214 - Québec
- Ps0011 203 - Surrey
- Ps0011 205 - Waterloo
- Ps0011 300 - Ostrava
- Ps0011 303 - Pardubice
- Ps0011 301 - Prague
- Ps0011 304 - Prague
- Ps0011 404 - Kecskemét
- Ps0011 400 - Orosháza
Texas
- Ps0011 733 - Dallas
- Ps0011 709 - Houston
- Ps0011 702 - Houston
California
- Ps0011 708 - Los Angeles
District of Columbia
- Ps0011 706 - Washington D.C.
Iowa
- Ps0011 704 - West Des Moines
North Carolina
- Ps0011 738 - Wilmington
Oregon
- Ps0011 712 - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2016-12-14 |
| Est. Completion | 2018-09-25 |
| Phase | Phase 2 |
What the finished NCT03010527 record still lists
NCT03010527 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 1,096-participant average among 6 other Chronic Plaque Psoriasis trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Chronic Plaque Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03010527 names 20 study sites across 7 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT03010527 about?
NCT03010527 is a clinical study titled "A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis". This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
What is the current status of trial NCT03010527?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2016-12-14. Estimated completion is 2018-09-25.
What conditions does trial NCT03010527 study?
This clinical trial studies the following conditions: Chronic Plaque Psoriasis.
What interventions are being tested in trial NCT03010527?
The interventions under investigation include: Placebo (OTHER), Bimekizumab (DRUG).
Who is sponsoring clinical trial NCT03010527?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03010527 being conducted?
This trial has 20 study locations across California, District of Columbia, Iowa, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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