Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

This clinical trial is focused on studying the long-term effects of a treatment for Hidradenitis Suppurativa, a skin condition that causes painful lumps under the skin, often in areas like the armpits and groin. The treatment being tested is called bimekizumab, which is given as a solution for injection. Bimekizumab is also known by its code name, UCB4940. The purpose of the study is to evaluate the safety of using bimekizumab over an extended period in adults with moderate to severe cases of this condition.

Participants in the study will receive bimekizumab through injections under the skin. The study will monitor participants for any side effects and assess how well the treatment works in managing the symptoms of Hidradenitis Suppurativa. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of bimekizumab. The study will also look at how the treatment affects the quality of life and skin pain experienced by participants.

The study is designed to last for several months, allowing researchers to gather information on the long-term use of bimekizumab. Participants will be regularly checked to ensure their safety and to track any changes in their condition. The results will help determine if bimekizumab is a safe and effective long-term treatment option for people with moderate to severe Hidradenitis Suppurativa.

1 joining the study

Participation begins after completing a previous study related to hidradenitis suppurativa.

Eligibility requires completion of the previous study’s treatment period and meeting specific criteria.

2 initial assessment

An initial assessment is conducted to confirm eligibility and ensure understanding of the study requirements.

This includes reviewing the ability to adhere to the study protocol and medication schedule.

3 treatment phase

The treatment involves the administration of bimekizumab, a solution for injection.

The medication is given through subcutaneous injection, which means it is injected under the skin.

The treatment period may extend up to 48 weeks, with possible additional extensions depending on specific criteria.

4 monitoring and follow-up

Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment.

This includes tracking any adverse events and assessing clinical responses using specific measures like HiSCR50 and HiSCR75.

Participants are also asked to complete questionnaires about symptoms and quality of life.

5 completion of study

The study is estimated to conclude by December 5, 2025.

Upon completion, final assessments are conducted to gather data on long-term treatment effects.

Who Can Join the Study?

  • The study participant must have completed the Maintenance Treatment Period through Week 48 in either HS0003 or HS0004 studies, was eligible to receive bimekizumab at the end of the previous study, and did not meet any withdrawal criteria from that study.
  • The study participant must be considered reliable and capable of following the study plan, which includes understanding and completing questionnaires, attending scheduled visits, and taking medication as instructed by the study doctor.
  • If the study participant is a female, she must not be pregnant or breastfeeding. Additionally, she must either not be a woman of childbearing potential (meaning she cannot become pregnant) or, if she can become pregnant, she must agree to use birth control during the study and for at least 20 weeks after the last dose of the study medication.
  • In France and Germany, participants who meet the criteria and provide informed consent can continue in the study for an additional 48-week treatment period. In France, this period can be extended for up to 40 more weeks if the criteria are met.

Who Cannot Join the Study?

  • Patients who have any other serious skin conditions that might interfere with the study.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a weakened immune system, which means their body has a harder time fighting infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other medical conditions that the study doctors think might make it unsafe for them to participate.
  • Patients who have had certain types of cancer in the past.
  • Patients who have active infections that need treatment.
  • Patients who have received certain treatments for Hidradenitis Suppurativa recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hautaerzte Zentrum Hannover GbR Hanover Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Medical Center Hera EOOD Sofia Bulgaria
St. Josef-Hospital Bochum Germany
Amphia Hospital Breda The Netherlands
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Havelklinik GmbH & Co. KG Berlin Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HIA Sainte Anne Toulon France
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Hospital Universitario Virgen Macarena Sevilla Spain
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nice Nice France
Hopital Prive D Antony Antony France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Polyclinique Courlancy-Bezannes Reims France
Direction Centrale Du Service De Sante Des Armees Toulon France
Uvnbmqensw Mdzhxgc Cfmzby Hwxllrvtfuzmfrqwo Hamburg Germany
Uwfuubgbihhe Mpdzgjn Ctoecez Goluyreds Groningen The Netherlands
Adwd &lxppeu Hopzphq Dn Lg Taeehi &mzunym Dkbvxukjuozfa Vhpteepuoamx Eh Marseille France
Evsvvck Uhkjfggyzixo Mriettq Cjuwoag Rkuxswdcy (riheauh Mhj Rotterdam The Netherlands
Ahukufe Oisffhzmznl Uafwxgogmfimu Cxitrbfjlqos Dcswf Svnoez E Dnqdz Siejsyy Dl Tgnrkw Turin Italy
Uyxambsxisbgemmaeoenh Mozhceql Avd Munster Germany
Peljqutww Iatpypgp Mouxvgzb Mecripfcsclt Stwzi Wpgrkrpibhcf I Apvbihgmpxdcq Warsaw Poland
Kxxtkynd dhq Ublolncepyah Mldqktjj Ahf Munich Germany
Dmilvaffws Sga z outl Wroclaw Poland
Hbjpqloy Do Lt Sjswg Cldj I Squp Pdm Barcelona Spain
Sm Vsicmwghzlyyffz Uwsyrkhxsw Hfrdmchr Dublin Ireland
Mrqelzm Cvzljy Mpfzblxkuc Ppqdbd Oub Pleven Bulgaria
Imhbhryd dc Crsmydnpszum Hnflcujjgwo Uytmxvkegfkkf dh Sipfa Erczagk (kckiitr Saint Priest En Jarez France

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
23.06.2021
France France
Not recruiting
23.06.2021
Germany Germany
Not recruiting
23.06.2021
Greece Greece
Not recruiting
23.06.2021
Ireland Ireland
Not recruiting
23.06.2021
Italy Italy
Not recruiting
23.06.2021
Poland Poland
Not recruiting
23.06.2021
Spain Spain
Not recruiting
23.06.2021
The Netherlands The Netherlands
Not recruiting
23.06.2021

Trial locations

Investigated drugs:

Bimekizumab is a medication being studied for its long-term safety in treating moderate to severe Hidradenitis Suppurativa, a chronic skin condition. It works by targeting specific proteins in the body that are involved in inflammation, helping to reduce the symptoms and flare-ups associated with the condition.

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve hair follicles becoming blocked and inflamed. Over time, the condition can lead to tunnels under the skin and significant scarring, affecting the quality of life.

Trial ID:
2024-511035-10-00
Protocol code:
HS0005
NCT ID:
NCT04901195
Trial Phase:
Therapeutic confirmatory (Phase III)

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    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Poland Spain