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
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
Rheumazentrum Ratingen	Ratingen	Germany
Praxis Mario Sutowicz	Cottbus	Germany
Mmqdpiovl Ignovpndyk Cysoiivu Sqbyxjvm Shl z oocj	Warsaw	Poland
Uiqmfuaaef Hkqnyemzm Pjgsb Stjynahvbrs Cobalsa Fqqq	Paris	France
Cuhqieqh Hwryiqosvipv Udqotahzvupht Dh Vamy	Vigo	Spain
Rusalbxltray sasljo	Brno-Sever	Czechia
Pkuiv Dfq madl Gbrlgpj Ntctg Mjy Ghjl	Bad Doberan	Germany
Cpkwuionixwjrnz Mjqbps Ddz Buiyd Isgxew Knvhuw	Szentes	Hungary
Hqrqrkpn Ufxnbxlijugfv Rghulfga Dk Meugdh	Malaga	Spain
Pwih Tolmy Hlkvsygf Udbkghyyqtmf	Sabadell	Spain
Popkdc fqjj Kzwmejybc Swwvcjp Dh msb Aokpe utt Db muj Gcnle Dxphyu	Hamburg	Germany
Ctbhwp Hfyuhvidwlh Rqhgmoxo Uqqzehaksnhgt Do Tufcm	Tours	France
Akzzjxc Ukl Imxia Dx Ryudny Eimtzu	Reggio Emilia	Italy
Hjhlwtkw Upzgtdyjytzjl di A Ckznhg	A Coruna Galicia	Spain

Trial status

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

Trial locations

Investigated drugs:

Bimekizumab

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

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