Sonelokimab for Hidradenitis Suppurativa

Recruiting at 100 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, Inflammatory bowel disease, 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

422 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. It's best to discuss this with the trial team or your doctor.

What evidence 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 like secukinumab have shown a good safety profile in clinical trials. ^{2 5 6 7 8}

How is the drug Sonelokimab different from other treatments for hidradenitis suppurativa?

Sonelokimab is unique because it targets both IL-17A and IL-17F, which are proteins involved in inflammation, using a nanobody (a small antibody fragment). This dual targeting approach may offer a more comprehensive way to reduce inflammation compared to other treatments that only target IL-17A, like secukinumab. ^{3 4 5 8 9}

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.

Research Team

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

Principal Investigator

MoonLake Immunotherapeutics AG

Eligibility Criteria

Adults with moderate to severe hidradenitis suppurativa (HS), a skin condition, who haven't responded well to antibiotics can join this trial. They must have had HS symptoms for at least 6 months and have lesions in two or more areas, one with fistulas.

Inclusion Criteria

I have had symptoms of hidradenitis suppurativa for at least 6 months.

Participants with a total AN count of ≥5

My skin condition didn't improve with antibiotics.

Exclusion Criteria

Participants with known hypersensitivity to sonelokimab or any of its excipients

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sonelokimab or placebo subcutaneously. Sonelokimab is administered 120 mg Q2W from Weeks 0 to 6, then 120 mg Q4W starting at Week 8 up to Week 48. Placebo is administered Q2W from Weeks 0 to 6, then Q4W starting at Week 8 up to Week 16, followed by sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22, then Q4W from Week 24 up to Week 48.

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sonelokimab

Trial Overview The study is testing Sonelokimab, given under the skin, against a placebo to see if it's better for treating HS. Participants are randomly chosen to get either the real drug or placebo in a 2:1 ratio until Week 16 of the study.

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

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]

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]

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]

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]

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]

Secukinumab, an IL-17A inhibitor, has shown promising efficacy in treating hidradenitis suppurativa, as demonstrated in the phase III SUNSHINE and SUNRISE clinical trials.

Unlike the currently FDA-approved treatment for hidradenitis suppurativa, adalimumab, which targets TNF-α, secukinumab offers a different mechanism of action that may benefit patients with this inflammatory skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab in the treatment of hidradenitis suppurativa. Snyder, CL., Gibson, RS., Porter, ML., et al.[2023]

References

1. 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]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

Secukinumab in the treatment of hidradenitis suppurativa. [2023]