35 Participants Needed

Sonelokimab for Hidradenitis Suppurativa

Recruiting at 16 trial locations
MC
Overseen ByMoonlake Clinical Trial Helpdesk
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: MoonLake Immunotherapeutics AG
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of the drug sonelokimab for teens with hidradenitis suppurativa (HS), a skin condition that causes painful lumps. Participants will receive sonelokimab injections over a period to assess its effects. The trial seeks teens who have experienced moderate to severe HS for over six months and have not responded well to antibiotics. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

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

Research has shown that sonelokimab is generally well-tolerated. In one study, sonelokimab was tested for hidradenitis suppurativa, a skin condition that causes painful bumps, and demonstrated good safety results. Another study examined its long-term safety, and most participants found it manageable.

The studies also indicated that the treatment significantly improved the condition, with some participants responding better to sonelokimab than to a placebo. This suggests that while the treatment is effective, it also maintains a good safety record. However, like any treatment, side effects may occur, so participants should discuss any concerns with their healthcare provider.12345

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

Most treatments for hidradenitis suppurativa, like antibiotics and TNF inhibitors, aim to reduce inflammation and manage symptoms. But Sonelokimab works differently, targeting a specific protein called IL-17A that plays a critical role in inflammatory processes. Researchers are excited because this targeted approach may offer more effective relief with fewer side effects. Plus, Sonelokimab is administered subcutaneously, which could be more convenient for patients compared to some current options.

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

Research has shown that sonelokimab holds promise for treating hidradenitis suppurativa (HS). In recent studies, 35.4% of patients taking sonelokimab experienced a 75% reduction in symptoms, compared to only 21.6% of those not receiving the treatment. Additionally, about 1 in 4 patients achieved complete relief from inflammation after 24 weeks. These findings suggest that sonelokimab can significantly reduce the painful symptoms of HS for many people. Overall, early data indicates that this treatment is effective, offering hope to those affected by this challenging skin condition.12367

Are You a Good Fit for This Trial?

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 have had symptoms of HS for 6 months or more.
I am between 12 and 17 years old.
See 3 more

Exclusion Criteria

Participants with history or concurrent clinically significant medical conditions or any other reason that would compromise safety or interfere with participation in the study
I do not have any skin conditions that could affect HS assessment.
Participants with a known hypersensitivity to sonelokimab or any of its excipients
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: sonelokimabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials
7
Recruited
2,800+

Published Research Related to This Trial

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.
A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa.Amano, M., Grant, A., Kerdel, FA.[2015]
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.
Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review.Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]
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.
Systematic review of immunomodulatory therapies for hidradenitis suppurativa.Lim, SYD., Oon, HH.[2020]

Citations

Press releasesIn June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis ...
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 ...
and IL-17F-inhibiting Nanobody sonelokimab in patients ...Furthermore, for 1 in 4 patients, inflammatory remission in the form of IHS4-100 was possible after 24 weeks of treatment with sonelokimab 120mg. Ongoing Phase ...
NCT07007637 | A Study to Evaluate the Long-term Safety, ...This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who ...
MoonLake claws back HS potential for sonelokimab on ...HiSCR75 is a common clinical outcome measure that quantifies a patient achieving a 75% reduction from baseline in HS-associated inflammatory ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40601333/
A Living Systematic Review and Network Meta-AnalysisMain outcomes and measures: Primary efficacy, safety, and tolerability outcomes were Hidradenitis Suppurativa Clinical Response (HiSCR)-50 ...
Phase 3 VELA Study Findings Suggest Sonelokimab ...In June 2023, topline findings from the MIRA trial showed that the study met its primary endpoint at 12-weeks for Hidradenitis Suppurativa ...
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