Ended Therapeutic confirmatory (Phase III) Hidradenitis Suppurativa

An extension study to learn if Bimekizumab is safe and works as a long-term therapy in adults with moderate to severe hidradenitis suppurativa

EU CTIS ID: 2024-511035-10-00

What this study is testing

Evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study.
  • Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator.
  • A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP). OR b) A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP).
  • In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.

You likely can't join if

  • Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP).
  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments. Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
  • Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated.
  • Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment.
  • Study participant plans to participate in another study of a medicinal product or device under investigation during this study.
  • In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Turkey
  • Japan
  • Canada
  • Switzerland
  • United States
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Turkey; Japan; Canada; Switzerland; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.