Bimekizumab for Hidradenitis Suppurativa

(BE HEARD EXT Trial)

Not currently recruiting at 194 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must be taking: Bimekizumab

Must not be taking: Systemic antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Serious infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests bimekizumab, a medication designed to treat moderate to severe hidradenitis suppurativa (HS), a chronic skin condition that causes painful lumps under the skin. The study's main goal is to assess the long-term safety of bimekizumab. Participants will be assigned to one of two different dosing regimens. The trial seeks individuals who have completed a previous bimekizumab study for HS without major issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that ongoing or planned use of certain treatments for hidradenitis suppurativa (HS) or other conditions might be prohibited. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that bimekizumab is generally safe for people with moderate to severe hidradenitis suppurativa (HS). In one study, patients experienced no new safety issues over a year, and most found the treatment manageable. Another study found that after two years, bimekizumab remained effective, and side effects were controlled. These results suggest that bimekizumab might be safe for long-term use in treating HS. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for hidradenitis suppurativa, which mainly include antibiotics and biologics like adalimumab, bimekizumab targets both interleukin-17A and interleukin-17F. This dual targeting could potentially offer a more comprehensive approach to reducing inflammation and lesions. Researchers are excited because this mechanism might provide better symptom control and improve the quality of life for patients who don't respond well to existing therapies.

What evidence suggests that bimekizumab might be an effective treatment for hidradenitis suppurativa?

Research has shown that bimekizumab effectively treats hidradenitis suppurativa (HS). Studies have found that it provides lasting symptom relief and helps control the disease over time. Patients often experience pain relief within two weeks, which continues throughout the treatment. After two years, more than half of the patients had only mild symptoms. The treatment has proven both effective and safe, with consistent results over three years. Participants in this trial will receive one of two different bimekizumab dosing regimens to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive long-term treatment with bimekizumab to evaluate safety in moderate to severe hidradenitis suppurativa

196 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Bimekizumab dosing regimen 2 Experimental Treatment 1 Intervention

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

Group II: Bimekizumab dosing regimen 1 Experimental Treatment 1 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:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis

Approved in United States as Bimzelx for:

• Moderate-to-severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis
• Hidradenitis suppurativa

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Published Research Related to This Trial

Adalimumab and infliximab are the most studied treatments for moderate to severe hidradenitis suppurativa (HS), with clinical trials showing their efficacy, while other agents like anakinra and ustekinumab also demonstrate promise.

Adalimumab is currently the only biologic approved by the FDA for HS, and most treatments have a good safety profile, although infections are the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. Lim, SYD., Oon, HH.[2020]

In patients with severe hidradenitis suppurativa (HS), there is an increase in specific inflammatory monocytes and a unique cytokine profile, indicating a complex immune response that could guide treatment choices.

Treatment with etanercept, a TNF blocker, showed clinical improvement linked to increased production of IL-1β and IL-17 in blood cells, suggesting that monitoring these cytokines could help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. Kanni, T., Tzanetakou, V., Savva, A., et al.[2018]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

A systematic review of 34 publications involving 105 patients with hidradenitis suppurativa (HS) found that TNF-alpha inhibitors, particularly infliximab, led to positive treatment outcomes in 90% of cases, indicating their potential efficacy in managing this challenging skin condition.

While side effects were reported in 8 out of 105 patients, they were similar to those seen in other studies with TNF-alpha inhibitors, suggesting a manageable safety profile; however, the need for more standardized reporting and randomized controlled trials is emphasized to better understand long-term effects and optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. Haslund, P., Lee, RA., Jemec, GB.[2018]

In a phase II study involving 243 patients with moderate-to-severe hidradenitis suppurativa (HS), risankizumab did not meet the primary endpoint of achieving HS Clinical Response (HiSCR) at week 16, indicating it may not be an effective treatment for this condition.

The safety profile of risankizumab was generally favorable, with low rates of treatment-emergent adverse events across all treatment groups, suggesting that while it may not be effective, it is also not associated with significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Kimball, AB., Prens, EP., Passeron, T., et al.[2023]

In a review of 12 randomized controlled trials involving 2915 patients, adalimumab and bimekizumab were found to be effective treatments for moderate-to-severe hidradenitis suppurativa, showing significant improvement in clinical response compared to placebo at 12-16 weeks.

All evaluated biologics, including adalimumab, bimekizumab, and secukinumab, demonstrated similar safety profiles with no increased risk of adverse effects compared to placebo, making them viable options for patients with refractory hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. Tsai, YC., Hung, CY., Tsai, TF.[2023]

Citations

1. ucb-usa.com ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-new-three-year-data-in-hidradenitis-suppurativa-at-eadv-showed-sustained-symptom-relief-across-multiple-clinical-endpoints

BIMZELX® (bimekizumab-bkzx) New Three-year Data in ... BIMZELX® (bimekizumab-bkzx) New Three-year Data in Hidradenitis Suppurativa at EADV Showed Sustained Symptom Relief Across Multiple Clinical ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40866757/

Long-Term Effectiveness and Safety of Bimekizumab in ... Bimekizumab shows sustained clinical effectiveness and a manageable safety profile for moderate-to-severe HS in real-world practice up to 48 ...

3. bimzelxhcp.com bimzelxhcp.com/HS/HS-Data/Results

Bimekizumab for adults with moderate-to-severe ... Patients also experienced rapid improvement in HSSDD worst skin pain as early as Week 2 and results were maintained over the 16 weeks in which HSSDD was ...

4. ucb.com ucb.com/newsroom/press-releases/article/bimzelxrvbimekizumab-two-year-data-at-ehsf-2025-demonstrate-sustained-disease-control-in-hidradenitis-suppurativa-hs

BIMZELX[®]▼(bimekizumab) two-year data at EHSF 2025 ... Reduced disease severity: After two years of BIMZELX®▽ (bimekizumab) treatment, 53.1% (237/446) of patients had mild disease compared to ...

5. dermatologytimes.com dermatologytimes.com/view/three-year-data-reinforce-long-term-efficacy-and-safety-of-bimekizumab-in-hidradenitis-suppurativa

Three-Year Data Reinforce Long-Term Efficacy and Safety ... Bimekizumab demonstrated durable efficacy and consistent safety in hidradenitis suppurativa over three years, maintaining high HiSCR scores and ...

6. bimzelxhcp.com bimzelxhcp.com/HS/Safety

Consistent safety profile across PSO and HS 1,2 BIMZELX® testing exhibited no new safety signals in one year: it was well tolerated by patients with HS. See short-term and long-term testing data for ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04242498

NCT04242498 | A Study to Evaluate the Efficacy and ... The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)