Bimekizumab for Hidradenitis Suppurativa

Recruiting at 16 trial locations

Overseen By UCB Cares

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must not be taking: IL-17 biologics

Disqualifiers: IBD, Active infections, Severe depression, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called bimekizumab to evaluate its effects on individuals with moderate to severe hidradenitis suppurativa (HS), a condition causing painful lumps under the skin. The goal is to understand how the body absorbs and processes the drug after injection. Participants must have had HS for at least six months, with at least five inflamed lumps in two different body areas, and must have tried antibiotics that proved ineffective. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that participants should not receive prohibited treatments close to the Baseline Visit. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

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

Research has shown that bimekizumab is generally safe for people with moderate to severe hidradenitis suppurativa (HS). Studies indicate that bimekizumab reduces symptoms over time, with manageable safety concerns. For up to three years, patients experienced symptom relief without major safety issues.

Safety data from studies lasting one and two years also demonstrate that bimekizumab is well-tolerated. While some patients might experience side effects, the treatment has been safe for most users.

In summary, bimekizumab has undergone testing over several years and has been found safe for many patients with HS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Bimekizumab is unique because it targets both IL-17A and IL-17F, two proteins involved in inflammation, while most current treatments for Hidradenitis Suppurativa, like antibiotics and TNF inhibitors, focus on different pathways. This dual mechanism of action may offer more comprehensive control of the inflammatory processes that drive the condition. Researchers are excited about Bimekizumab because it has the potential to provide more effective relief with possibly fewer flare-ups compared to existing options.

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

Research has shown that bimekizumab effectively treats moderate to severe hidradenitis suppurativa (HS). Studies have found that it reduces symptoms and improves patients' quality of life over time. Data from three years of research indicate that bimekizumab offers long-lasting relief and meets strict medical goals. Many patients notice quick improvements, such as reduced skin pain, within two weeks of starting treatment. Overall, bimekizumab appears to be a promising option for effectively managing HS symptoms. ^{3 6 7 8 9}

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 children and adolescents aged 12 to less than 18 with moderate to severe Hidradenitis Suppurativa (HS). They must have been diagnosed at least 6 months prior, have ≥5 inflammatory lesions in at least two areas, one being Hurley Stage II or III. Participants need a history of inadequate response to antibiotics for HS and weigh over 30kg.

Inclusion Criteria

I have 5 or more inflamed skin lesions from HS.

I weigh at least 30kg.

I have been diagnosed with HS for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a weight-dependent dose of bimekizumab subcutaneously

16 weeks

Regular visits for dosing and monitoring

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 study tests the pharmacokinetics (how the body processes) and safety of Bimekizumab when given as a subcutaneous injection in young patients with HS. It aims to understand how this medication behaves in their bodies over time.

How Is the Trial Designed?

Group I: Bimekizumab Experimental Treatment 1 Intervention

Study participants will receive a bimekizumab dose which is weight-dependent.

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

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]

Hidradenitis suppurativa (HS) is a challenging chronic skin condition with limited treatment options, where adalimumab is currently the only approved biologic, effective in only 50% of patients.

New biologic agents targeting the IL-17 pathway, such as bimekizumab and secukinumab, have shown promising efficacy and safety in phase III trials, with secukinumab recently receiving approval from the EMA for HS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-17 Inhibition: A Valid Therapeutic Strategy in the Management of Hidradenitis Suppurativa. Malvaso, D., Calabrese, L., Chiricozzi, A., et al.[2023]

In a phase 2 study involving 209 patients with hidradenitis suppurativa, povorcitinib, a selective Janus kinase 1 inhibitor, significantly reduced the number of abscesses and inflammatory nodules compared to placebo over 16 weeks.

Povorcitinib also showed a higher percentage of patients achieving clinical response at week 16, with no increase in adverse events compared to placebo, indicating its potential as a safe and effective treatment for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study. Kirby, JS., Okun, MM., Alavi, A., et al.[2023]

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]

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]

Adalimumab is currently the only biologic drug approved for treating hidradenitis suppurativa (HS), a chronic inflammatory skin condition that can lead to serious systemic health issues.

There is a wide range of potential treatments for HS under investigation, targeting various pathways such as TNF-alpha and IL-17, but more studies are needed to evaluate their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future. Mansilla-Polo, M., Escutia-Muñoz, B., Botella-Estrada, R.[2023]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40652434/

Bimekizumab Impact on Patient-Reported Outcomes in ... Bimekizumab improved the symptoms and quality of life of patients with moderate to severe HS over 1 year. This suggests that bimekizumab is an effective ...

2. ucb.com ucb.com/newsroom/press-releases/article/bimzelxrvbimekizumab-new-three-year-data-in-hidradenitis-suppurativa-at-eadv-showed-sustained-disease-control-across-the-most-stringent-clinical-endpoints

BIMZELX[®]▼(bimekizumab) new three-year data in ... “The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as ...

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

Bimekizumab for adults with moderate-to-severe ... BIMZELX delivered fast and lasting improvement in. HS symptoms · Patients also experienced rapid improvement in HSSDD worst skin pain as early as Week 2 and ...

4. ucbcompass.com ucbcompass.com/sites/default/files/2025-01/WCMiami25_BE%20HEARD%20I%26II%202-Year%20Efficacy%20%26%20Safety.pdf

Bimekizumab efficacy and safety through 2 years in ... Safety outcomes were reported for patients who received ≥1 BKZ dose across BHI&II/BHEXT. • Data were reported for patients randomized to BKZ in BHI&II and.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673624001016

Efficacy and safety of bimekizumab in patients with ... The BE HEARD I and II trials showed that patients with hidradenitis suppurativa treated with bimekizumab reached rapid and maintained improvements in the signs ...

6. 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 weeks.

7. 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 ... Bimekizumab efficacy and safety through 3 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and ...

8. ucb.com ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-data-in-hidradenitis-suppurativa-showed-improvements-in-pain-and-resolution-of-draining-tunnels-sustained-to-three-years

BIMZELX[®] (bimekizumab-bkzx) data in hidradenitis ... BIMZELX[®] (bimekizumab-bkzx) data in hidradenitis suppurativa showed improvements in pain and resolution of draining tunnels sustained to three ...

9. jaad.org jaad.org/article/S0190-9622(25)01286-1/fulltext

63331 Bimekizumab safety and tolerability in patients with ... [1] 1- and 2-year safety data for bimekizumab (BKZ), a humanized monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients ...