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Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called bimekizumab in adults with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often occurring in people who have psoriasis, a skin condition that leads to red, scaly patches. The medication being tested, bimekizumab, is given as an injection under the skin and is designed to help manage the symptoms of this condition.

The purpose of the study is to assess how safe and tolerable bimekizumab is when used over an extended period. Participants in the study will receive regular injections of bimekizumab and will be monitored to see how their condition responds to the treatment. The study will also track any side effects that may occur during the treatment period.

Throughout the study, participants will have regular check-ups to evaluate their health and the effectiveness of the treatment. The study aims to provide valuable information on the long-term use of bimekizumab for managing Psoriatic Arthritis, helping to determine if it is a safe and effective option for patients with this condition.

1 joining the study

Upon joining the study, the participant is required to have completed a previous study without meeting any withdrawal criteria.

Female participants must be postmenopausal, permanently sterilized, or willing to use a highly effective method of contraception.

2 treatment administration

The participant will receive bimekizumab, which is a solution for injection.

The medication is administered through subcutaneous use, meaning it is injected under the skin.

3 monitoring and assessments

Throughout the study, the participant will be monitored for any treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

The study aims to assess the long-term safety and tolerability of bimekizumab in treating active psoriatic arthritis.

4 evaluation of treatment response

The participant’s response to treatment will be evaluated at various intervals, including weeks 24, 52, and 140.

Assessments will include measures such as the American College of Rheumatology (ACR) improvement criteria and the Psoriasis Area Severity Index (PASI).

5 study completion

The study is estimated to end on May 19, 2026.

Upon completion, the participant’s overall health and response to the treatment will be reviewed.

Who Can Join the Study?

  • The person must have Psoriatic Arthritis, which is a type of arthritis that affects some people who have the skin condition psoriasis.
  • The person should be expected to benefit from participating in this study, according to the study doctor.
  • The person must have completed a previous study, identified as PA0010 or PA0011, without needing to leave the study early for any reason.
  • Female participants must either be postmenopausal (which means they have stopped having periods), permanently sterilized (which means they cannot have children), or willing to use a very effective form of birth control.
  • Both men and women can participate in the study.
  • The study is for adults, which generally means people who are 18 years or older.

Who Cannot Join the Study?

  • Patients who are not adults cannot participate. This means you must be 18 years or older.
  • Patients who do not have psoriatic arthritis cannot participate. Psoriatic arthritis is a condition that affects the joints and is often associated with a skin condition called psoriasis.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or people who might not be able to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Reumaclinic Genk Belgium
Rheumatologische Schwerpunktpraxis Berlin Germany
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
PV-Medical s.r.o. Zlin Czechia
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o Wroclaw Poland
University Of Debrecen Debrecen Hungary
Affidea Praha s.r.o. Prague Czechia
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Sp. p. Elblag Poland
Hospital Universitario Virgen Macarena Sevilla Spain
Hospital Universitario Reina Sofía Cordoba Spain
Pratia Pardubice a.s. Pardubice Czechia
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
CHU Helora La Louviere Belgium
Universitaetsklinikum Leipzig AöR Leipzig Germany
Centrum Medyczne Amed Sp. z o.o. Warsaw Poland
Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH Frankfurt Germany
Mtnxviglc Ijrrpdafwd Chloseew Sctasiyl Sxl z onvz Warsaw Poland
Ujldjyfqis Hxktvrndb Pcidw Shbpfdhcval Clxnmid Fgau Paris France
Cnfrgrbp Hvrpsjwxzxyi Uuyywfkhwqtbn Di Vnho Vigo Spain
Rqymqanbdsmz svownb Brno-Sever Czechia
Pfebs Dog mswe Gwpodwk Nfloi Mql Gdgr Bad Doberan Germany
Cjmmqclwpssrfpc Mwtgom Dkn Biplu Ijpvan Kptzyk Szentes Hungary
Hjjdawza Uijtbszgpvjuv Rvdaazxj Dm Mmjkfn Malaga Spain
Ppea Teevz Hodugvqw Ucpozkbwbuna Sabadell Spain
Pbubsf ficz Kcbeeddbb Sbkjjou Dg mav Aedmr ujo Dm mrk Gttki Dulksy Hamburg Germany
Cuvdpq Hhmiosbspmw Rhrdvrbt Uauxutdwzipxi Dm Tlfna Tours France
Aachgdo Uej Ivknp Dg Ryhtax Ejfyxe Reggio Emilia Italy
Hofhqxdo Uxpwzcdzcjcbv de A Ckdwhq A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.11.2019
Czechia Czechia
Not recruiting
21.11.2019
France France
Not recruiting
21.11.2019
Germany Germany
Not recruiting
21.11.2019
Hungary Hungary
Not recruiting
21.11.2019
Italy Italy
Not recruiting
21.11.2019
Poland Poland
Not recruiting
21.11.2019
Spain Spain
Not recruiting
21.11.2019

Trial locations

Investigated drugs:

Bimekizumab is a medication used in this clinical trial to treat adults with active psoriatic arthritis. It is administered through an injection under the skin. The purpose of using bimekizumab in this study is to evaluate its long-term safety and how well patients can tolerate it. Additionally, the trial aims to understand how effective bimekizumab is in managing the symptoms of psoriatic arthritis over an extended period.

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals who have psoriasis, a skin condition characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, often affecting fingers and toes, leading to a sausage-like appearance known as dactylitis. Over time, psoriatic arthritis can lead to joint damage and reduced range of motion. The condition may also involve inflammation where tendons and ligaments attach to bones, known as enthesitis. Symptoms can vary in severity and may come and go, with periods of flare-ups and remission.

Trial ID:
2023-506528-95-00
Protocol code:
PA0012
NCT ID:
NCT04009499
Trial Phase:
Therapeutic confirmatory (Phase III)

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