Sonelokimab for Hidradenitis Suppurativa

Not currently recruiting at 114 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new treatment, sonelokimab (an anti-inflammatory drug), for people with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps. Participants will receive either the treatment or a placebo (a harmless substance) to compare results. The trial seeks adults who have experienced symptoms for at least 6 months and have not found success with antibiotics. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance 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. It's best to discuss this with the trial team or your doctor.

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

Research has shown that sonelokimab, a new treatment being tested for hidradenitis suppurativa, has demonstrated promising safety results in earlier studies. In one study on its use for psoriatic arthritis, most patients tolerated the treatment well. Some side effects occurred, but they were uncommon. For instance, fewer than 10% of patients experienced significant side effects.

Sonelokimab is not entirely new. It belongs to a group of medications called IL-17 inhibitors, which target specific proteins involved in inflammation. Similar treatments are already used for other conditions, providing some confidence about its safety.

Overall, while no treatment is without risk, sonelokimab appears well-tolerated based on previous trial data. Discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

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

Researchers are excited about sonelokimab for treating Hidradenitis Suppurativa because it represents a fresh approach in tackling this challenging condition. Most current treatments, like antibiotics or anti-inflammatory drugs, focus on managing symptoms rather than addressing the underlying inflammation. Sonelokimab is different because it targets interleukin-17A and interleukin-17F, key proteins involved in inflammatory processes, potentially offering more precise and effective relief. This new mechanism of action could mean better outcomes for patients who haven't found success with existing options.

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

Research has shown that sonelokimab, which participants in this trial may receive, may help treat hidradenitis suppurativa (HS), a painful skin condition. One study found that about 35.4% of patients using sonelokimab experienced a 75% reduction in painful skin bumps, compared to 21.6% of patients who improved with a placebo, which contains no active medicine. Another study supported these findings, with 34.8% of patients achieving the same level of improvement with sonelokimab. These results suggest that sonelokimab could be a helpful treatment for people with moderate to severe HS. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Principal Investigator

MoonLake Immunotherapeutics AG

Are You a Good Fit for This Trial?

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

Participants with a total AN count of ≥5

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

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Press releases

MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab.

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MoonLake Shares Findings from Dual Phase 3 Trials of ...

Sonelokimab demonstrated significant efficacy in hidradenitis suppurativa, achieving HiSCR75 response rates of 35.4% versus 21.6% for placebo at ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11750882/

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trial.medpath.com/news/48d30c462ec9a9a8/moonlake-immunotherapeutics-advances-sonelokimab-through-phase-3-trials-for-multiple-inflammatory-conditions

MoonLake Immunotherapeutics Advances Sonelokimab ...

The company has launched the Phase 3 VELA trials for hidradenitis suppurativaSearch disease in May 2025, with results expected to arrive in mid- ...

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firstwordpharma.com

firstwordpharma.com/story/6227241

Pair of pivotal hidradenitis studies for MoonLake's ...

Results showed VELA-1 met its primary endpoint, with 34.8% of patients on sonelokimab achieved HiSCR75 — a 75% reduction in inflammatory lesions ...

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synapse.patsnap.com

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A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants

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(PDF) Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody ...

Table 2 | Safety through week 24. Patients with events, n (%) Part A (weeks 0–12) Parts A and B (weeks 0–24). PBO, n = 39 SLK 60-mg.