Sonelokimab for Hidradenitis Suppurativa
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: MoonLake Immunotherapeutics AG
Disqualifiers: Inflammatory bowel disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
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.
12345How 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).
23678Eligibility 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.
+3 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
+4 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: sonelokimabExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical SiteColumbus, IN
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Who Is Running the Clinical Trial?
MoonLake Immunotherapeutics AGLead Sponsor
References
Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]Hidradenitis suppurativa (HS) is a common inflammatory skin disease. Medical treatment is often disappointing and in severe disease surgery remains the therapy of choice. Extensive surgery may be effective but also mutilating. Patients experience a significant reduction in quality of life and the need for new treatment modalities are urgent. In recent years patients with HS have been treated off-label with tumour necrosis factor-alpha (TNF-alpha) inhibitors with a varying degrees of effect. We performed a systematic review of papers retrieved from two databases (PubMed and Web of Science) using the follow-ing keywords: hidradenitis suppurativa, acne inversa, infliximab, etanercept, and adalimumab. A total of 34 publications were retrieved, describing treatment of 105 patients. Most cases report treatment with infliximab (52/105). A positive treatment outcome was reported in 90/105 cases, with only 7/105 non-responders and 8/105 patients experiencing side-effects. The side-effects were comparable to those seen in other TNF-alpha inhibitor studies. In the majority of cases the treatment was effective when given as a suppressive therapy, but 15/105 cases were described with long-term remission (>or= 3 months) after the end of therapy. In most publications follow-up was, however, insufficient to allow a systematic exploration of this. TNF-alpha inhibitors seem to be effective in the treatment of HS. However, several questions remain to be answered through specific studies. This review has also identified a need for more standardized reporting of the outcomes as well as randomized controlled trials in this disease.
Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]Background: Greater understanding of the roles of tumor necrosis factor-α, IL-1β, IL-10, and the IL-23/T-helper (Th) 17 and IL-12/Th1 pathways in immune dysregulation in moderate/severe hidradenitis suppurativa (HS) has helped in developing new regimens. We aim to review the use of different immunomodulatory therapies used to manage HS. Methods: A comprehensive literature search was conducted on the PubMed and Clinicaltrials.gov databases from 1 January 1947 to 31 December 2018. Only clinical trials, case reports, case series and retrospective analyses published in the English language were included. Results: Our search yielded 107 articles and 35 clinical trials, of which 15 are still ongoing. The tumor necrosis factor-α inhibitors adalimumab and infliximab were the most comprehensively studied agents. Published data from clinical trials support the efficacy of adalimumab, infliximab, anakinra, ustekinumab, bermekimab and apremilast but not etanercept and MEDI8968. Clinical trials for CJM112 have been completed, with results awaiting publication. Trials are underway for secukinumab, IFX-1, INCB054707 and bimekizumab. Biologics used in smaller cohorts include canakinumab, golimumab and rituximab. Most agents are well tolerated and demonstrate a good safety profile, with the most commonly reported adverse event being infections. Discussion and conclusions: To date, adalimumab is the only biologic which has been approved by the United States Food and Drug Administration for HS. However, other agents also show promise, with further trials underway to evaluate their efficacy, tolerability and safety profiles. Different clinical measurement scores and endpoints used to make direct comparison difficult. Longitudinal surveillance and pooled registry data are paramount to evaluate the long-term safety profile and efficacy of therapy.
Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]The IL-17 pathway is a potential therapeutic target shown to be implicated in hidradenitis suppurativa (HS), however, it remains unclear whether evidence from mechanistic studies may translate into clinical practice. This systematic review summarizes available treatment outcomes of IL-17 inhibitors in patients with HS. Embase, MEDLINE, PubMed, and clinicaltrials.gov were comprehensively searched on February 26, 2021 to include 16 original studies representing 128 patients with HS (mean age: 36.5 years; age range: 21-47 years; male: 50.0%). Treatment outcomes were reported for the following biologics: secukinumab (n = 105), brodalumab (n = 22), and ixekizumab (n = 1). Patients were classified as responders or non-responders according to achievement of a positive response/improvement based on criteria established for each included study. For secukinumab 57.1% (n = 60/105) of patients were responders in a mean response period of 16.2 weeks and 42.9% (n = 45/105) were non-responders; for brodalumab, 100.0% (n = 22/22) of patients were responders within 4.4 weeks; and the one patient treated with ixekizumab was a responder within 10 weeks. In conclusion, IL-17 inhibitors may serve as an effective therapeutic target in approximately two-thirds of patients with HS and can be considered in those who are refractory to other treatment modalities. We also stress the importance of consistent outcome measures to enhance evidence synthesis, decrease reporting bias, provide potential for future meta-analysis, and ultimately improve clinical outcomes for patients with HS.
A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa. [2015]To evaluate the safety and efficacy of adalimumab for the management of hidradenitis suppurativa (HS).
Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. [2023]Adalimumab is a human monoclonal antibody against tumor necrosis factor-α that was approved in Japan for the treatment of hidradenitis suppurativa (HS), a chronic recurrent inflammatory skin disease. We report the results of the final analysis of the postmarketing surveillance (PMS) study (ClinicalTrials.gov: NCT03894956), which evaluated the 52-week safety and efficacy of adalimumab for HS treatment in real-world clinical practice in Japan. This multicenter, prospective, open-label, observational study (March 2019 to May 2021) included patients with HS treated with subcutaneous adalimumab at doses following the package insert. The primary endpoint was safety, and the secondary endpoints were effectiveness, including HS clinical response (HiSCR), C-reactive protein (CRP), skin pain, and Dermatology Life Quality Index (DLQI). Of the 84 patients registered at 65 sites, 83 patients were included in the analyses. Adverse drug reactions (ADRs) were reported by 10 (12.0%) patients; two patients reported a serious ADR, including one patient with serious infection. Other safety events of special interest reported were liver disorder and dermatitis psoriasiform (one patient each). Almost all patients with ADRs were recovering or had recovered, except for one patient who experienced a serious ADR of liver disorder and died. At 12 weeks, 55.4% of patients achieved HiSCR; this increased to 60.5% and 62.8% at 24 and 52 weeks of adalimumab treatment, respectively. Significant reductions from baseline in CRP (P
Novel Regimen of IL-17A Inhibitor Secukinumab for the Remission of Severe Hidradenitis Suppurativa: Case Report. [2022]Hidradenitis suppurativa (HS) is a morbid, recurrent skin condition that presents a major challenge to clinical therapy. Investigation into the pathogenesis of HS has implicated local and systemic pro-inflammatory cytokines, particularly TNF-α and IL-17A, as major determinants of disease progression and severity. This has ushered in a revolution in HS therapy with biologics targeting these cytokines. We report a case of a 36-year-old man with extensive and treatment-resistant Hurley Stage 3 HS. After undergoing numerous unsuccessful trials of topical, systemic, and biologic therapies, secukinumab therapy with 150 mg weekly injections was initiated. HS clinical response was seen after 20 weeks and was maintained for almost two years. Secukinumab 150 mg or 300 mg once weekly may be an effective and safe therapeutic option for moderate-to-severe chronic HS. J Drugs Dermatol. 2022;21(12):1358-1360. doi:10.36849/JDD.6752.
Pharmacological development in hidradenitis suppurativa. [2020]Hidradenitis suppurativa (HS) is a chronic, inflammatory, debilitating disease of a relapsing nature which presents with nodules, abscesses, and suppurating lesions of intertriginous areas of the skin. Within recent years, there has been significant progress in terms of the treatment of HS, nevertheless, an unmet need of treatment exists and effective therapy remains a serious challenge. The current treatment strategies are focused on known pathomechanisms underlying and responsible for development of HS lesions, including hyperkeratinization and occlusion of pilosebaceous unit, dysbiosis and the extensive, chronic inflammation. Several cytokines (i.e. TNF-a, IL-1, IL-17, and IL-23) seem to be involved in HS pathogenesis, and their blockade appears as a rational therapeutic approach. So far TNF inhibition with adalimumab remains the only EMA-approved/FDA-approved agent in HS treatment and should be consequently considered first. Other drugs, however, play an increasing role in off-label therapy. In recent years, new phase II and III trials for HS management have appeared aimed at inhibition of specific targetable inflammatory pathways identified in HS. Thus, several new biologics are being investigated, including MABp1 (bermekimab), CJM112, bimekizumab, guselkumab, secukinumab, and IFX-1.
Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. [2023]Background: Treatment of hidradenitis suppurativa (HS) is difficult and current guidelines are based mainly on expert opinion and non-randomized controlled trials. Recently, there have been some targeted therapies using uniform primary endpoints for outcome assessment. Objective: Recommendations can be provided on selecting biologics and targeted synthetic small molecules for refractory HS by comparing the efficacy and safety of these medications. Methods: Databases including ClinicalTrial.gov, Cochrane Library, and PubMed were searched. Randomized controlled trials (RCTs) for moderate-to-severe HS were eligible. We performed random-effect network meta-analysis and ranking probability. The primary outcome was Hidradenitis Suppurativa Clinical Response (HiSCR) at 12-16 weeks. Secondary outcome included Dermatology Life Quality Index (DLQI) 0/1, mean change of DLQI from baseline, and adverse effects. Results: A total of 12 RCTs involving 2915 patients were identified. Adalimumab, bimekizumab, secukinumab 300 mg q4w and secukinumab 300 mg q2w showed superiority to placebo in HiSCR at weeks 12 to 16. In addition, there was no significant difference between bimekizumab and adalimumab as measured by HiSCR (RR = 1.00; 95% CI: 0.66-1.52) and DLQI 0/1 (RR = 2.40, 95% CI: 0.88-6.50). In terms of ranking probability for achieving HiSCR at 12-16 weeks, adalimumab ranked first, followed by bimekizumab, secukinumab 300 mg q4w, and secukinumab 300 mg q2w. All biologics and small molecules did not differ in the development of adverse effects compared to placebo. Conclusions: Adalimumab, bimekizumab, secukinumab 300 mg q4w and secukinumab 300 mg q2w represent four regimens that produce better outcomes than placebo without increased risk of adverse events. Adalimumab and bimekizumab exhibited best HiSCR and DLQI 0/1 between weeks 12-16.