Bimekizumab for Hidradenitis Suppurativa

Recruiting at 6 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

Trial Summary

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.

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

Research shows that Bimekizumab, along with other similar drugs, leads to better outcomes than a placebo for treating Hidradenitis Suppurativa, without increasing the risk of side effects. It ranks second in effectiveness, just after Adalimumab, in achieving significant clinical response and improving quality of life within 12-16 weeks. ^{1 2 3 4 5}

Is Bimekizumab safe for humans?

Bimekizumab has been studied for its safety in treating hidradenitis suppurativa and other conditions. Research shows that it does not increase the risk of adverse effects compared to a placebo, meaning it is generally considered safe for humans. ^{1 2 4 6 7}

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

Bimekizumab is unique because it targets the IL-17 pathway, which is involved in the inflammation seen in hidradenitis suppurativa. This mechanism is different from the only currently FDA-approved treatment, adalimumab, which targets TNF-α (a different inflammatory pathway). ^{3 4 6 8 9}

What is the purpose of this trial?

The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

References

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

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

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

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. [2018]

3. 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]

4. 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]

5. Australia pubmed.ncbi.nlm.nih.gov

Moderate to severe hidradenitis suppurativa treated with biological therapies. [2015]

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

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

7. Spain pubmed.ncbi.nlm.nih.gov

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

IL-17 Inhibition: A Valid Therapeutic Strategy in the Management of Hidradenitis Suppurativa. [2023]

9. United States 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. [2023]