Bimekizumab for Hidradenitis Suppurativa
(BE HEARD EXT Trial)

Recruiting in Palo Alto (17 mi)

+172 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing the safety of bimekizumab, a medication for people with moderate to severe hidradenitis suppurativa (HS). Bimekizumab aims to reduce inflammation and alleviate symptoms by targeting certain proteins in the body.

Eligibility Criteria

This trial is for individuals with moderate to severe hidradenitis suppurativa who have completed a previous study (HS0003 or HS0004) without withdrawal. Participants must not be pregnant, breastfeeding, and women of childbearing potential must agree to follow contraceptive guidance.

Inclusion Criteria

A study participant is considered to be reliable and capable of adhering to the protocol (e.g., able to understand and complete questionnaires), visit schedule, and medication intake, according to the judgement of the Investigator

I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.

I can follow the study's schedule and take medications as directed.

+1 more

Exclusion Criteria

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

I have a positive or unclear TB test but have been checked or treated.

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

+2 more

Participant Groups

The trial is testing the long-term safety of Bimekizumab in treating moderate to severe hidradenitis suppurativa. It's an extension study for those who've already been on Bimekizumab during earlier trials.

2Treatment groups

Experimental Treatment

Group I: Bimekizumab dosing regimen 2Experimental Treatment1 Intervention

Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.

Group II: Bimekizumab dosing regimen 1Experimental Treatment1 Intervention

Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.

Bimekizumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Bimzelx for: