Sign in

NCT04009499CompletedPhase 3

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

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1131 (actual)
First submitted
2 Jul 2019
Start date
13 Aug 2019
Primary completion date
26 May 2026
Lead sponsor
UCB Biopharma SRL
NCT number
NCT04009499
EU CT number
2023-506528-95-00
EudraCT number
2018-004725-86

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1131
  • From 13 Aug 2019 to the primary completion date, 26 May 2026
  • 114 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
  • Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (114)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pa0012 30005
Coordinator of this site? Confirm its status
CamberwellAustraliaUnknown status
Pa0012 30002
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Pa0012 30008
Coordinator of this site? Confirm its status
HobartAustraliaUnknown status
Pa0012 30003
Coordinator of this site? Confirm its status
MaroochydoreAustraliaUnknown status
Pa0012 30007
Coordinator of this site? Confirm its status
Victoria ParkAustraliaUnknown status
Pa0012 30006
Coordinator of this site? Confirm its status
Woodville SouthAustraliaUnknown status
ReumaClinic
Coordinator of this site? Confirm its status
GenkBelgiumCompleted
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumCompleted
CHU Helora
Coordinator of this site? Confirm its status
MonsBelgiumCompleted
Pa0012 50041
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Pa0012 50042
Coordinator of this site? Confirm its status
RimouskiCanadaUnknown status
Pa0012 50043
Coordinator of this site? Confirm its status
SydneyCanadaUnknown status
Pa0012 50044
Coordinator of this site? Confirm its status
Trois-RivièresCanadaUnknown status
Revmatologie s.r.o.
Coordinator of this site? Confirm its status
Brno-SeverCzechiaCompleted
Pratia Pardubice a.s.
Coordinator of this site? Confirm its status
Pardubice ICzechiaCompleted
Affidea Praha s.r.o.
Coordinator of this site? Confirm its status
Prague 11CzechiaCompleted
Pratia Prague s.r.o.
Coordinator of this site? Confirm its status
Prague 3CzechiaCompleted
PV Medical S R O
Coordinator of this site? Confirm its status
ZlínCzechiaCompleted
Prof. Dr. med. Gunther Neeck MVZ GmbH
Coordinator of this site? Confirm its status
Bad DoberanGermanyCompleted
Rheumatologische Schwerpunktpraxis
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Praxis Mario Sutowicz
Coordinator of this site? Confirm its status
CottbusGermanyCompleted
Universitaetsklinikum Erlangen AöR
Coordinator of this site? Confirm its status
ErlangenGermanyCompleted
Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyCompleted
Praxis fur Klinische Studien und Praxis fur Orthopadie
Coordinator of this site? Confirm its status
HamburgGermanyCompleted
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Coordinator of this site? Confirm its status
HamburgGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Coordinator of this site? Confirm its status
HerneGermanyCompleted
Universitaetsklinikum Leipzig Aor
Coordinator of this site? Confirm its status
LeipzigGermanyCompleted
Rheumazentrum Ratingen
Coordinator of this site? Confirm its status
RatingenGermanyCompleted
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainCompleted
Hospital General Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainCompleted
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainCompleted
Parc Tauli Hospital Universitari
Coordinator of this site? Confirm its status
SabadellSpainCompleted
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainCompleted
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainCompleted
Complexo Hospitalario Universitario De Vigo
Coordinator of this site? Confirm its status
VigoSpainCompleted
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Chambray Les ToursFranceCompleted
University Hospitals Pitie Salpetriere - Charles Foix
Coordinator of this site? Confirm its status
ParisFranceCompleted
Pa0012 40109
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Pa0012 40116
Coordinator of this site? Confirm its status
PeterboroughUnited KingdomUnknown status
Pa0012 40107
Coordinator of this site? Confirm its status
WolverhamptonUnited KingdomUnknown status
Central Hospital Of Northern Pest Military Hospital
Coordinator of this site? Confirm its status
Budapest VIHungaryCompleted
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryCompleted
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
Coordinator of this site? Confirm its status
SzentesHungaryCompleted
Azienda USL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyCompleted
Pa0012 20035
Coordinator of this site? Confirm its status
Bunkyō CityJapanUnknown status
Pa0012 20030
Coordinator of this site? Confirm its status
ChūōkuJapanUnknown status
Pa0012 20036
Coordinator of this site? Confirm its status
Kawachi-NaganoJapanUnknown status
Pa0012 20045
Coordinator of this site? Confirm its status
Kita-gunJapanUnknown status
Pa0012 20049
Coordinator of this site? Confirm its status
KitakyushuJapanUnknown status
Pa0012 20044
Coordinator of this site? Confirm its status
MinatokuJapanUnknown status
Pa0012 20033
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Pa0012 20046
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Pa0012 20041
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Pa0012 20048
Coordinator of this site? Confirm its status
SaitamaJapanUnknown status
Pa0012 20031
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Pa0012 20042
Coordinator of this site? Confirm its status
SaseboJapanUnknown status
Pa0012 20032
Coordinator of this site? Confirm its status
SuitaJapanUnknown status
Pa0012 20043
Coordinator of this site? Confirm its status
tabashi CityJapanUnknown status
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Coordinator of this site? Confirm its status
ElblagPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
Nowa SolPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Klinika Reuma Park Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Centrum Medyczne Amed Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
Coordinator of this site? Confirm its status
WroclawPolandCompleted
WroMedica I Bielicka A Strzalkowska s c
Coordinator of this site? Confirm its status
WroclawPolandCompleted
Pa0012 20002
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Pa0012 20010
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Pa0012 20005
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Pa0012 20017
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Pa0012 20013
Coordinator of this site? Confirm its status
PetrozavodskRussiaUnknown status
Pa0012 20012
Coordinator of this site? Confirm its status
RyazanRussiaUnknown status
Pa0012 20016
Coordinator of this site? Confirm its status
RyazanRussiaUnknown status
Pa0012 20083
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Pa0012 20009
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Pa0012 20001
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Pa0012 20004
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Pa0012 20003
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Pa0012 20007
Coordinator of this site? Confirm its status
SaratovRussiaUnknown status
Pa0012 20014
Coordinator of this site? Confirm its status
UlyanovskRussiaUnknown status
Pa0012 20006
Coordinator of this site? Confirm its status
VladimirRussiaUnknown status
Pa0012 20015
Coordinator of this site? Confirm its status
YaroslavlRussiaUnknown status
Pa0012 20008
Coordinator of this site? Confirm its status
YaroslavlRussiaUnknown status
Pa0012 50029
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Pa0012 50039
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Pa0012 50002
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Pa0012 50023
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status
Pa0012 50050
Coordinator of this site? Confirm its status
BeckleyUnited StatesUnknown status
Pa0012 50024
Coordinator of this site? Confirm its status
BoiseUnited StatesUnknown status
Pa0012 50047
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Pa0012 50010
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Pa0012 50125
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Pa0012 50049
Coordinator of this site? Confirm its status
Corpus ChristiUnited StatesUnknown status
Pa0012 50020
Coordinator of this site? Confirm its status
DuncansvilleUnited StatesUnknown status
Pa0012 50005
Coordinator of this site? Confirm its status
FreeholdUnited StatesUnknown status
Pa0012 50015
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Pa0012 50001
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
Pa0012 50008
Coordinator of this site? Confirm its status
JohnstonUnited StatesUnknown status
Pa0012 50019
Coordinator of this site? Confirm its status
LansingUnited StatesUnknown status
Pa0012 50028
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
Pa0012 50012
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Pa0012 50036
Coordinator of this site? Confirm its status
MesquiteUnited StatesUnknown status
Pa0012 50011
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Pa0012 50007
Coordinator of this site? Confirm its status
OrangeburgUnited StatesUnknown status
Pa0012 50033
Coordinator of this site? Confirm its status
Palm HarborUnited StatesUnknown status
Pa0012 50017
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Pa0012 50034
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Pa0012 50035
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
Pa0012 50016
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Pa0012 50037
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Pa0012 50040
Coordinator of this site? Confirm its status
VandaliaUnited StatesUnknown status
Pa0012 50009
Coordinator of this site? Confirm its status
WacoUnited StatesUnknown status
Pa0012 50031
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status
Pa0012 50006
Coordinator of this site? Confirm its status
WyomissingUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.