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Active (not recruiting) Phase 3 NCT04009499

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Phase 3 – large-scale trial before approval
Conditions: Psoriatic Arthritis

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
Who can participate
Inclusion Criteria: * In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study * Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria * Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception Exclusion Criteria: * Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP) * Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator * Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
Locations 14
Australia (1)
Pa0012 30005
Camberwell
Belgium (1)
Pa0012 40003
Genk
Canada (1)
Pa0012 50041
Québec
Czech Republic (1)
Pa0012 40061
Brno
France (1)
Pa0012 40068
Chambray-lès-Tours
Germany (1)
Pa0012 40074
Bad Doberan
Hungary (1)
Pa0012 40081
Budapest
Italy (1)
Pa0012 40084
Catania
Japan (1)
Pa0012 20035
Bunkyō City
Poland (1)
Pa0012 40093
Bialystok
Russia (1)
Pa0012 20002
Moscow
Spain (1)
Pa0012 40045
A Coruña
United Kingdom (1)
Pa0012 40109
Oxford
United States (1)
Pa0012 50017
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.08.2019
Completion date
25.05.2026
Registry ID
NCT04009499
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.