Sonelokimab for Hidradenitis Suppurativa

Recruiting at 9 trial locations

Overseen By Moonlake Clinical Trial Helpdesk

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: MoonLake Immunotherapeutics AG

Disqualifiers: Inflammatory bowel disease, 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: 8

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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.

Is Sonelokimab safe for use in humans?

There is no specific safety data available for Sonelokimab in the provided research articles. However, similar treatments for hidradenitis suppurativa, like adalimumab, have shown a good safety profile with infections being the most common side effect. ^{1 2 3 4 5}

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

Sonelokimab is unique because it targets the IL-17 pathway, which is a specific part of the immune system involved in inflammation. This makes it different from the only FDA-approved treatment, adalimumab, which targets a different inflammatory pathway (TNF-alpha). ^{2 3 6 7 8}

What is the purpose of this trial?

This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.

Eligibility Criteria

This trial is for adolescents with moderate to severe Hidradenitis Suppurativa (HS), a skin condition that causes small, painful lumps under the skin. The study aims to understand how the body processes Sonelokimab and its safety in this age group.

Inclusion Criteria

I weigh at least 40 kg.

I am between 12 and 17 years old.

I have had symptoms of HS for 6 months or more.

Exclusion Criteria

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

Participants with history or concurrent clinically significant medical conditions or any other reason that would compromise safety or interfere with participation in the study

Participants with a known hypersensitivity to sonelokimab or any of its excipients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive sonelokimab 120mg subcutaneously as an induction regimen of 4 doses

8 weeks

4 visits (in-person)

Maintenance Treatment

Participants receive sonelokimab subcutaneously every 4 weeks as a maintenance dose starting at Week 8

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sonelokimab

Trial Overview The focus of this study is on Sonelokimab, a medication being tested for HS. It's an open-label, single-arm trial, meaning all participants will receive the drug and there won't be any placebo or comparison group.

Participant Groups

Group I: sonelokimab Experimental Treatment 1 Intervention

Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials

7

Recruited

2,800+

Findings from Research

A systematic review of 34 publications involving 105 patients with hidradenitis suppurativa (HS) found that TNF-alpha inhibitors, particularly infliximab, led to positive treatment outcomes in 90% of cases, indicating their potential efficacy in managing this challenging skin condition.

While side effects were reported in 8 out of 105 patients, they were similar to those seen in other studies with TNF-alpha inhibitors, suggesting a manageable safety profile; however, the need for more standardized reporting and randomized controlled trials is emphasized to better understand long-term effects and optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. Haslund, P., Lee, RA., Jemec, GB.[2018]

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]

In a study involving 10 patients with hidradenitis suppurativa, adalimumab treatment did not lead to a significant clinical improvement in disease severity over 12 weeks, as measured by the HS Severity Index and other assessment tools.

Despite the lack of efficacy, adalimumab was well tolerated among participants, with no serious adverse events reported, suggesting it may be safe for use in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa. Amano, M., Grant, A., Kerdel, FA.[2015]

In a 52-week postmarketing surveillance study involving 83 patients with hidradenitis suppurativa (HS), adalimumab was found to be well tolerated, with only 12% reporting adverse drug reactions, and most patients recovering from these events.

Efficacy results showed that 62.8% of patients achieved a significant clinical response (HiSCR) by the end of the study, along with notable reductions in inflammation (CRP), skin pain, and quality of life (DLQI), indicating that adalimumab is effective for long-term treatment of HS in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. Hayashi, N., Hayama, K., Takahashi, K., et al.[2023]

Secukinumab, a biologic therapy targeting IL-17A, showed a significant clinical response in a 36-year-old man with severe, treatment-resistant hidradenitis suppurativa after 20 weeks of treatment, and this response was maintained for nearly two years.

This case suggests that secukinumab at doses of 150 mg or 300 mg weekly may be a safe and effective option for patients with moderate-to-severe chronic hidradenitis suppurativa, especially after other treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Regimen of IL-17A Inhibitor Secukinumab for the Remission of Severe Hidradenitis Suppurativa: Case Report. Gutierrez, E., Issa, N., Resnik, B.[2022]

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that causes painful lesions, and while there have been advancements in treatment, effective therapies are still needed.

Adalimumab is currently the only FDA-approved treatment for HS, but new biologics targeting specific inflammatory pathways are being tested in clinical trials, showing promise for future therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological development in hidradenitis suppurativa. Matusiak, Ł., Jemec, GB., Szepietowski, JC.[2020]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa. [2015]

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

Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. [2023]

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

Novel Regimen of IL-17A Inhibitor Secukinumab for the Remission of Severe Hidradenitis Suppurativa: Case Report. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacological development in hidradenitis suppurativa. [2020]

8. 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]