What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa that target interleukin pathways, such as Bimekizumab, include other interleukin-17 inhibitors like secukinumab and ixekizumab. Known side effects of these treatments can include increased risk of infections (such as nasopharyngitis), headache, and injection site reactions. Additionally, there may be a risk of inflammatory bowel disease events. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Hidradenitis Suppurativa, primarily focusing on the inhibition of inflammatory pathways. Adalimumab (Humira) is one such drug, which targets tumor necrosis factor-alpha (TNF-α) and has been approved for moderate to severe HS. While Bimekizumab, which inhibits interleukin-17A and interleukin-17F, is being studied for its efficacy in HS, other interleukin inhibitors like Secukinumab (which targets IL-17A) have also been explored for similar inflammatory conditions, though not specifically approved for HS. These treatments aim to reduce the chronic inflammation and lesions associated with the disease.

What other types of research exist?

Promising novel alternatives to Bimekizumab for Hidradenitis Suppurativa patients in 2024 include: <ol> <li>Secukinumab (IL-17A inhibitor)</li> <li></li> </ol> Ixekizumab (IL-17A inhibitor) 3. Guselkumab (IL-23 inhibitor) 4. Risankizumab (IL-23 inhibitor) 5. Tildrakizumab (IL-23 inhibitor) These agents have shown efficacy in related inflammatory conditions and may offer potential benefits for HS patients.

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Monoclonal Antibodies

Bimekizumab for Hidradenitis Suppurativa (BE HEARD EXT Trial)

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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 ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to the long-term use of Bimekizumab as part of their treatment regimen.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I am not using any forbidden treatments for my skin condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 16, week 32, week 48, week 76, week 92, week 100, week 116, week 132, week 148, week 164, and week 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with treatment-emergent adverse events (TEAEs) during the study

Secondary study objectives

Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain

Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimekizumab

2018

Completed Phase 3

~6510

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses. Common treatments for HS often target specific components of the immune system to reduce inflammation. Bimekizumab, for example, inhibits interleukin-17A (IL-17A) and interleukin-17F (IL-17F), which are cytokines involved in the inflammatory response. By blocking these cytokines, Bimekizumab can reduce the inflammation and immune response that contribute to the symptoms of HS. This mechanism is crucial for HS patients as it directly addresses the underlying inflammation, potentially leading to reduced pain, fewer flare-ups, and improved quality of life.