Sonelokimab for Hidradenitis Suppurativa

Recruiting at 86 trial locations

Overseen By Moonlake Clinical Trial Helpdesk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: MoonLake Immunotherapeutics AG

Disqualifiers: Active skin disease, Autoimmune disease, IBD, others

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: 48 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research shows that drugs targeting the IL-17 pathway, like secukinumab, have been effective in treating Hidradenitis Suppurativa (HS), with a significant number of patients responding positively. Since Sonelokimab also targets IL-17, it may offer similar benefits for HS patients. ^{1 2 3 4 5}

What safety data exists for Sonelokimab and similar treatments for Hidradenitis Suppurativa?

Most biologic treatments for Hidradenitis Suppurativa, including those targeting the IL-17 pathway, are generally well tolerated with infections being the most common side effect. While specific safety data for Sonelokimab is not detailed, similar treatments have shown a good safety profile in clinical trials. ^{1 2 6 7 8}

What makes the drug Sonelokimab unique for treating Hidradenitis Suppurativa?

Sonelokimab is unique because it is a nanobody, which is a small, single-domain antibody that can specifically target and block certain proteins involved in inflammation, potentially offering a more precise and effective treatment for Hidradenitis Suppurativa compared to traditional therapies. ^{9 10 11 12 13}

Research Team

Prof Kristian Reich, M.D., Ph.D. (equ.)

Principal Investigator

MoonLake Immunotherapeutics AG

Eligibility Criteria

Adults with moderate to severe hidradenitis suppurativa, having at least 5 inflammatory nodules and lesions in 2 or more areas, one with fistulas. They must have had symptoms for over 6 months and not responded well to antibiotics.

Inclusion Criteria

My skin condition didn't improve after antibiotic treatment.

I am at least 18 years old.

I have HS with sores in 2 or more areas, including at least one with fistulas.

Exclusion Criteria

Participants with known hypersensitivity to sonelokimab or any of its excipients

I do not have any autoimmune diseases that could affect my HS symptom assessment.

I do not have any skin conditions that could affect HS assessment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sonelokimab or placebo subcutaneously, with dosing adjustments from Weeks 0 to 48

48 weeks

Bi-weekly visits initially, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sonelokimab

Trial Overview The trial is testing the effectiveness of Sonelokimab given under the skin versus a placebo in treating hidradenitis suppurativa. Participants will be randomly assigned to receive either Sonelokimab or placebo until Week 16.

Participant Groups

Group I: sonelokimab Experimental Treatment 1 Intervention

Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48.

Group II: Placebo Placebo Group 1 Intervention

Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials

7

Recruited

2,800+

Findings from Research

Secukinumab, an IL-17A monoclonal antibody, showed promising results in treating a 47-year-old man with severe hidradenitis suppurativa (HS), significantly reducing the number of lesions from 23 to 7 after 12 weeks of treatment.

The patient also reported decreased pain levels, with his pain visual analogue scale (VAS) score improving from 5 to 3, suggesting that targeting IL-17A may be an effective therapeutic strategy for managing HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hidradenitis suppurativa responding to treatment with secukinumab: a case report. Thorlacius, L., Theut Riis, P., Jemec, GBE.[2022]

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]

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]

A detailed analysis of skin-infiltrating T cells in patients with hidradenitis suppurativa (HS) revealed a significant presence of inflammatory T helper (Th) type 17 cells, which are associated with the disease's chronic inflammation.

Treatment with anti-tumor necrosis factor (TNF) therapy led to a reduction in Th17 cells and improved the balance between Th17 and regulatory T cells, suggesting that targeting IL-17 may be an effective strategy for managing HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis Suppurativa Is Characterized by Dysregulation of the Th17:Treg Cell Axis, Which Is Corrected by Anti-TNF Therapy. Moran, B., Sweeney, CM., Hughes, R., et al.[2018]

Secukinumab, an anti-IL-17A monoclonal antibody, has been approved for treating moderate to severe Hidradenitis suppurativa (HS), marking a significant advancement in therapy for this chronic inflammatory skin disorder affecting 0.4% to 2.5% of the global population.

Clinical trials have demonstrated the safety and efficacy of secukinumab in HS, providing a new treatment option alongside the previously approved adalimumab, which targets a different inflammatory pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology of Interleukin-17 and Novel Therapies for Hidradenitis Suppurativa. Sabat, R., Gudjonsson, JE., Brembilla, NC., 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]

The IL-17 pathway is suggested to play a significant role in the development of hidradenitis suppurativa, a chronic skin condition.

This finding highlights the potential for targeting the IL-17 pathway in future treatments for hidradenitis suppurativa, based on immunological evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining targets to defeat hidradenitis suppurativa. Lev-Tov, H.[2019]

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]

The study successfully developed nanobody blockers targeting the PD-1/PD-L1 interaction, which is crucial for cancer immunotherapy, by analyzing the interaction interface and screening a humanized nanobody library.

The selected nanobody, PD-1-Nb-B20, effectively inhibited PD-1 binding to pancreatic adenocarcinoma cells that over-express PD-L1, demonstrating its potential as a therapeutic agent in blocking this immune checkpoint interaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanobodies targeting the interaction interface of programmed death receptor 1 (PD-1)/PD-1 ligand 1 (PD-1/PD-L1). Wen, B., Zhao, L., Wang, Y., et al.[2023]

The study evaluated a recombinant anti-CD3 nanobody, which effectively activated T cells and inhibited tumor growth in tumor-bearing mice, suggesting its potential as a cancer treatment.

Treatment with the anti-CD3 nanobody increased levels of tumor-fighting cytokines (IL-2 and IFNγ) while decreasing tolerogenic cytokines, indicating a shift towards a stronger anti-tumor immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation the potential of recombinant anti-CD3 nanobody on immunomodulatory function. Moradi-Kalbolandi, S., Sharifi-K, A., Darvishi, B., et al.[2020]

G250 antigen-targeting temsirolimus-loaded nanobubbles (G250-TNBs) significantly enhance the targeting and treatment of renal cell carcinoma (RCC) by improving drug delivery and increasing the effectiveness of ultrasound-targeted nanobubble destruction (UTND).

In both in vitro and in vivo studies, G250-TNBs demonstrated superior tumor targeting and inhibition of tumor growth compared to standard temsirolimus-loaded nanobubbles, indicating a promising new approach for localized RCC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G250 Antigen-Targeting Drug-Loaded Nanobubbles Combined with Ultrasound Targeted Nanobubble Destruction: A Potential Novel Treatment for Renal Cell Carcinoma. Yu, Z., Wang, Y., Xu, D., et al.[2022]

The administration of recombinant anti-CD3 nanobody during a 24-day treatment period significantly reduced angiogenic biomarkers and delayed tumor growth in mice, indicating its potential effectiveness in cancer immunotherapy.

Nanobody treatment not only suppressed tumor growth but also increased survival rates, suggesting a promising approach to enhance the host's anti-tumor immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo tumor-suppressing and anti-angiogenic activities of a recombinant anti-CD3ε nanobody in breast cancer mice model. Khatibi, AS., Roodbari, NH., Majidzade-A, K., et al.[2020]

Nanobody-based tools have shown promise for noninvasive diagnostics in bladder cancer by enriching and removing specific proteins from urine samples, which could enhance traditional diagnostic methods.

In a study of 22 bladder cancer patients, increased levels of major blood proteins and immune complexes were found in urine, suggesting potential new biomarkers for monitoring disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Single-Domain Antibodies Used to Pretreat the Human Urinary Proteome in Cancer Biomarker Testing]. Tillib, SV., Goryainova, OS., Sachko, AM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Severe hidradenitis suppurativa responding to treatment with secukinumab: a case report. [2022]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Hidradenitis Suppurativa Is Characterized by Dysregulation of the Th17:Treg Cell Axis, Which Is Corrected by Anti-TNF Therapy. [2018]

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

Biology of Interleukin-17 and Novel Therapies for Hidradenitis Suppurativa. [2023]

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

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. [2018]

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

Defining targets to defeat hidradenitis suppurativa. [2019]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Nanobodies targeting the interaction interface of programmed death receptor 1 (PD-1)/PD-1 ligand 1 (PD-1/PD-L1). [2023]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation the potential of recombinant anti-CD3 nanobody on immunomodulatory function. [2020]

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

G250 Antigen-Targeting Drug-Loaded Nanobubbles Combined with Ultrasound Targeted Nanobubble Destruction: A Potential Novel Treatment for Renal Cell Carcinoma. [2022]

12. England pubmed.ncbi.nlm.nih.gov

In vivo tumor-suppressing and anti-angiogenic activities of a recombinant anti-CD3ε nanobody in breast cancer mice model. [2020]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Single-Domain Antibodies Used to Pretreat the Human Urinary Proteome in Cancer Biomarker Testing]. [2022]