Bimekizumab for Hidradenitis Suppurativa

(BE HEARD EXT Trial)

Recruiting at 173 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

658 Participants Needed

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.

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.

What data supports the effectiveness of the drug Bimekizumab for treating Hidradenitis Suppurativa?

Research shows that Bimekizumab, along with other similar drugs like adalimumab and secukinumab, is more effective than a placebo in improving symptoms of Hidradenitis Suppurativa without increasing the risk of side effects. Bimekizumab has shown comparable effectiveness to adalimumab, which is already approved for this condition. ^{1 2 3 4 5}

How does the drug Bimekizumab differ from other treatments for hidradenitis suppurativa?

Bimekizumab is unique because it targets both IL-17A and IL-17F, which are proteins involved in inflammation, offering a novel approach compared to other treatments that typically target only one of these proteins or other pathways. This dual inhibition may provide a more comprehensive reduction in inflammation for patients with hidradenitis suppurativa. ^{1 5 6 7 8}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

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.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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]

References

1. Switzerland 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. [2023]

2. Sweden pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Guselkumab effectiveness, and posology in patients with moderate to severe hidradenitis suppurativa: A retrospective bicentric experience. [2022]