sonelokimab (M1095) / EMD Serono, Avillion, MoonLake Immunotherap - LARVOL DELTA

An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: MoonLake Immunotherapeutics AG | Active, not recruiting ➔ Completed

Trial completion

Decoding the IL-17 axis in hidradenitis suppurativa: Pharmacodynamic profiling of the Nanobody® sonelokimab reveals IL-19 and PI3 as biomarkers of IL-17 pathway activity (ISDS 2025) - P2 | "Protein levels were measured at baseline and after 12 weeks of sonelokimab, placebo, or adalimumab treatment to assess pharmacodynamic responses. IL-19 and PI3 are robust pharmacodynamic IL-17 pathway biomarkers of disease activity in HS. Their normalization following sonelokimab treatment underscores the drug's targeted mechanism of action and supports their potential utility in monitoring therapeutic response, further validating IL-17A and IL-17F as central drivers of HS pathogenesis."

Biomarker • PK/PD data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Positive phase II trial of IL-17A-IL-17F-targeting nanobody sonelokimab for PsA. (PubMed, Nat Rev Rheumatol) - No abstract available

Journal • P2 data • IL17A

Important upcoming anticipated milestones for MoonLake (GlobeNewswire) - "Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA; Q2 2026: 52 weeks data of the VELA-1 and VELA-2 trials in HS; Q2 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA; Q2 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS; Q3 2026: Initiate Phase 3 trial in PPP; Q3/Q4 2026: Submission of a BLA; H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA."

Clinical data • FDA filing • New P3 trial • Ankylosing Spondylitis • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis

MoonLake Immunotherapeutics…New Data from Clinical Trials of its Nanobody Sonelokimab (Businesswire) - "In an interim analysis of long-term data from MoonLake's Phase 3 clinical trials in adult patients with HS, the VELA-1 and VELA-2 trials, SLK demonstrates continuous clinical improvement and potentially competitive advantages beyond the week 16 primary endpoint. The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA)....An interim analysis of the VELA-TEEN clinical trial, a Phase 3 study of SLK in adolescent HS patients, showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11)....The data is expected to be part of MoonLake's BLA submission."

FDA event • P3 data • Hidradenitis Suppurativa

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=1560 | Not yet recruiting | Sponsor: MoonLake Immunotherapeutics AG

New P3 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

MoonLake Immunotherapeutics (MLTX) Faces Investor Scrutiny After Reporting Disappointing Phase 3 Trial Data For Lead Drug Candidate -- Hagens Berman [Google translation] (GlobeNewswire) - "Investors in MoonLake Immunotherapeutics...saw the price of their shares crater $55.75, or about 90%, after the company announced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or 'HS')....Investors’ expectations were dashed on Sep. 29, 2025, when MoonLake announced that in its VELA-2 trial 'intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%[.]'"

P3 data • Stock price • Hidradenitis Suppurativa

A securities class action, styled Bridgewood v. MoonLake Immunotherapeutics, et al., No. 1:25-cv-08500 (S.D.N.Y), has been filed after MoonLake…announced disastrous Phase 3 trial results for its only product candidate (sonelokimab, or “SLK”), its highly anticipated treatment for patients with skin disease (hidradenitis suppurativa or “HS”). (GlobeNewswire) - "The litigation is focused on the propriety of MoonLake’s statements about the trial design and data for SLK...Central to SLK’s commercial prospects was its ability to demonstrate efficacy in HS comparable or superior to a competitor’s FDA-approved product ('BIMZELX'), which is used for the same HS indication and targets the same cytokines."

Corporate lawsuit • Hidradenitis Suppurativa

Sonelokimab in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs: Phase 2 ARGO Analysis and Phase 3 IZAR-1 Study Design (ACR Convergence 2025) - P2, P3 | "The Phase 2 ARGO study demonstrated high levels of clinical response with SLK, including in patients with active PsA naive to bDMARDs. The randomized Phase 3 IZAR-1 study will further assess outcomes with SLK in patients naive to bDMARDs and is actively recruiting, including at sites across the USA."

Clinical • P2 data • P3 data • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Sonelokimab in Biologic-Experienced Patients With Active Psoriatic Arthritis: Results From a Phase 2 Trial (ARGO) and Study Design of a Phase 3 Trial (IZAR-2) in Patients With Inadequate Response or Intolerance to Biologic TNFi, Including a Risankizumab Reference Arm (ACR Convergence 2025) - P2, P3 | "In patients with active PsA and prior exposure to >1 bDMARD in the Phase 2 ARGO trial, SLK 120mg and 60mg WI showed efficacy in controlling signs and symptoms of PsA and achieving MDA response. Interpretation is limited by patient numbers; hence, a larger Phase 3 trial specifically in patients with prior inadequate response or intolerance to biologic TNFi (IZAR-2) is ongoing and actively recruiting at sites across the USA."

Clinical • P2 data • P3 data • Immunology • Inflammation • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL23A

Effects of Sonelokimab, an IL-17A- and IL-17F-Inhibiting Nanobody, on Patient-Reported Symptoms and Quality of Life in Psoriatic Arthritis: Results From the Randomized, Double-Blind, Placebo-Controlled Phase 2 ARGO Trial (ACR Convergence 2025) - P2, P3 | "Patients were randomized to SLK 120mg Q4W (with induction [WI] doses at Weeks [W] 0, 2, 4, and 6), SLK 60mg Q4W WI, SLK 60mg Q4W with no induction (NI), PBO, or adalimumab 40mg Q2W (reference arm; not powered for statistical comparisons). Patients treated with SLK in ARGO reported significant improvements in the symptoms and impact of PsA. Ongoing Phase 3 studies (IZAR-1: NCT06641076; IZAR-2: NCT06641089) will further assess the effect of SLK on PROs and QoL in larger patient populations."

Clinical • HEOR • P2 data • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Impact of Sonelokimab, a Novel IL-17A- and IL-17F-Inhibiting Nanobody, in Active Psoriatic Arthritis: Key Subgroup Analyses in the Randomized, Double-Blind, Placebo-Controlled Phase 2 ARGO Trial (ACR Convergence 2025) - P2, P3 | "Patient characteristics, including sex, weight, concomitant methotrexate (MTX) use, and baseline disease activity levels may influence responses to bDMARDs (Eder et al, Lancet Rheumatol. Robust efficacy with SLK was observed irrespective of key baseline clinical characteristics in ARGO, including for populations in which disparate outcomes of treatment have been reported, such as female patients. Ongoing Phase 3 studies (IZAR-1: NCT06641076; IZAR-2: NCT06641089) will further evaluate SLK 60mg and 120mg in active PsA."

Clinical • P2 data • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. (PubMed, Nat Med) - P2 | "Overall, 207 patients with active PsA were randomized to SLK 120-mg or 60-mg every 4 weeks (Q4W; both with induction (WI)), or to 60-mg Q4W with no induction, PBO or adalimumab (reference arm). Overall, SLK delivered substantial improvements in the signs and symptoms of PsA across various outcomes and domains. ClinicalTrials.gov registration: NCT05640245 ."

Clinical • Journal • P2 data • Candidiasis • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Next-Generation Therapies for Hidradenitis Suppurativa: Recent FDA Approvals and a Look at Clinical Trial Landscape (EADV 2025) - "Over the past decade, numerous immunotherapies have been developed for a wide range of dermatologic conditions, including two recently FDA-approved treatments for HS within the last year (bimekizumab and secukinumab)2,3...Sonelokimab, another IL-17A/F inhibitor, is currently in a recruiting phase 3 trial...Other cytokine-targeting agents are lutikizumab (IL-1α/IL-1β inhibitor), spesolimab (anti-IL-36R), and anifrolumab (type I interferon receptor antagonist)...Agents targeting the JAK-STAT pathway include the JAK1 inhibitors povorcitinib, upadacitinib, and ruxolitinib, as well as deucravacitinib, a tyrosine kinase 2 inhibitor; all are currently under investigation for HS...Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, also showed promising results, with 72.7% of patients reaching the HiSCR endpoint at week 167. Brensocatib, a dipeptidyl-peptidase 1 inhibitor, is currently being evaluated in a recruiting phase 3 trial... The last decade has brought a wave..."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IFNAR2 • IL17A • IL1B • TYK2

An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: MoonLake Immunotherapeutics AG | Recruiting ➔ Active, not recruiting

Enrollment closed

The Company continues to progress with the development of its Nanobody sonelokimab across a portfolio of indications… (GlobeNewswire) - "Q4 2025: Primary endpoint readout of the Phase 2 LEDA trial in PPP; Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA; Q2 2026: 52 weeks data of the VELA-1 and VELA-2 trials in HS."

P2 data • P3 data • Ankylosing Spondylitis • Dermatology • Hidradenitis Suppurativa

MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody sonelokimab (GlobeNewswire) - "In VELA-1, sonelokimab achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053)."

P3 data • Hidradenitis Suppurativa

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "Our review shows that, compared to placebo, the biologics infliximab, xeligekimab, bimekizumab, ixekizumab, and risankizumab were the most effective treatments for achieving PASI 90 in people with moderate-to-severe psoriasis, with high-certainty evidence for bimekizumab and moderate-certainty evidence for infliximab, xeligekimab, ixekizumab, and risankizumab. This network meta-analysis evidence is limited to induction therapy (outcomes measured from 8 to 24 weeks after randomisation), and is not sufficient for evaluating longer-term outcomes in this chronic disease. Moreover, we found low numbers of studies for some of the interventions, and the young age (mean 44.4 years) and high level of disease severity (PASI 20.5 at baseline) may not be typical of people seen in daily clinical practice. More randomised trials directly comparing active agents are needed, and these should include systematic subgroup analyses (sex, age, ethnicity, comorbidities, psoriatic arthritis)...."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

Effects of sonelokimab, an IL-17A- and IL-17F-inhibiting Nanobody, on patient-reported symptoms and quality of life in psoriatic arthritis: Results from the randomized, double-blind, placebo-controlled Phase 2 ARGO trial (EADV 2025) - P2, P3 | "Patients were randomized to SLK 120mg Q4W (with induction [WI] doses at Week [W] 0, 2, 4, and 6), SLK 60mg Q4W WI, SLK 60mg Q4W with no induction (NI), PBO, or adalimumab (reference arm, not powered for statistical comparisons). Patients treated with SLK in ARGO reported robust improvements in the symptoms and impact of PsA, including in the PsAID-12 skin domain. Ongoing Phase 3 studies (IZAR-1: NCT06641076 and IZAR-2: NCT06641089) will further characterize the effect of SLK on PROs and QoL. B."

Clinical • HEOR • P2 data • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Impact of sonelokimab, a novel IL-17A- and IL-17F-inhibiting Nanobody, on skin, nail, and multidomain clinical outcomes in active psoriatic arthritis: results from the randomized, double-blind, placebo-controlled Phase 2 ARGO trial (EADV 2025) - P2, P3 | "Patients were randomized 1:1:1:1:1 to SLK 60mg with no induction (NI), SLK 60mg or SLK 120mg WI, PBO, or adalimumab (ADA) (reference arm; not powered for statistical comparisons). SLK demonstrated robust efficacy on high-hurdle skin, nail, and joint outcomes, as well as on multidomain clinical outcomes, with consistent and robust benefits seen across key patient subgroups. No unexpected safety findings were observed. Ongoing Phase 3 studies (IZAR-1: NCT06641076 and IZAR-2: NCT06641089) will evaluate SLK 60mg and 120mg in active PsA."

Clinical • Clinical data • P2 data • Candidiasis • CNS Disorders • Depression • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL17A

A randomized, double-blind, placebo-controlled Phase 3 clinical trial of sonelokimab—including a risankizumab reference arm—in patients with active psoriatic arthritis and previous inadequate response or intolerance to biologic TNFi therapy (IZAR-2): Study design and rationale (EADV 2025) - P3 | "After W16, patients receiving placebo will switch to sonelokimab 120mg Q4W WI (induction dosing to W24) until the end of treatment at W52. The IZAR-2 trial is ongoing and actively recruiting at sites across Europe and North America."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL23A

Improvement of hidradenitis suppurativa (HS)-related quality-of-life impairment with the IL‑17A- and IL-17F-inhibiting Nanobody sonelokimab: HiSQOL outcomes in the Phase 2 MIRA trial of patients with moderate-to-severe HS (EADV 2025) - P2, P3 | "HiSQOL outcomes in MIRA demonstrate the potential of sonelokimab to improve symptoms, psychosocial burden, and activity impairment in patients with moderate-to-severe HS. Although HiSQOL burden at baseline was higher in patients with a greater number of DDILs, these patients showed strong HiSQOL improvements with sonelokimab. Three Phase 3 trials (VELA-1: NCT06411899; VELA-2: NCT06411379; VELA-TEEN: NCT06768671) are now evaluating sonelokimab 120mg in larger cohorts of patients with moderate-to-severe HS, which will enable further exploration of HiSQOL outcomes."

Clinical • HEOR • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Deep dermal inflammatory lesions (DDILs) drive symptom and quality-of-life burden for patients with moderate-to-severe hidradenitis suppurativa (HS): insights from the MIRA trial population (EADV 2025) - P2, P3 | "DDILs worsen symptom and QoL burden in HS, with As having a similarly high impact to DTs. Additionally, HS-specific scores such as HiSQOL may be more sensitive than broader QoL scores, such as the DLQI. WPAI outcomes were particularly impacted by DDILs, underscoring the devastating impact of these painful lesions on day-to-day life."

Clinical • HEOR • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Existing and novel measures of hidradenitis suppurativa (HS) flares and symptom exacerbations indicate high levels of disease control with the Nanobody sonelokimab in the Phase 2 MIRA trial (EADV 2025) - P2, P3 | "Symptom exacerbations showed potential utility as a more sensitive definition of flare, with a nearly three-fold increase in flare rates in patients not receiving active treatment compared with the lesion count increase score currently used in clinical trials. Sonelokimab showed high levels of disease control, with 90% of patients receiving sonelokimab 120mg remaining flare free over 24 weeks as per the lesion count increase score, and 68% as per the global symptom exacerbation score. Three Phase 3 trials (VELA-1: NCT06411899; VELA-2: NCT06411379; VELA-TEEN: NCT06768671) are evaluating sonelokimab 120mg in larger cohorts of patients with moderate-to-severe HS, which will enable further exploration of flare and symptom exacerbation outcomes."

P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Resolution of deep dermal inflammatory lesions with the Nanobody sonelokimab in moderate-to-severe hidradenitis suppurativa (HS): preclinical results and outcomes from the Phase 2 MIRA trial (EADV 2025) - P3 | "Abscesses and draining tunnels are major drivers of QoL burden in HS, suggesting a need for early intervention to limit the development of these DDILs. Sonelokimab—a Nanobody designed to inhibit inflammation deep in the dermis—normalized neutrophil recruitment factors in an ex vivo model. In patients, sonelokimab led to rapid and substantial improvements in DDIL count in the 24-week Phase 2 MIRA trial."

P2 data • Preclinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • CCL20 • CXCL8 • IL17A