Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sonelokimab · 10 trials · 3 indications
Treatment-emergent adverse events (TEAEs)
Incidence, relatedness, severity and seriousness of all AEs
Incidence, relatedness, severity and seriousness of all TEAEs
Incidence, relatedness, severity and seriousness of all AESIs
Number of participants discontinued from sonelokimab treatment due to AEs
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
PK (trough concentrations) of sonelokimab over 24 weeks of treatment
Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Number of participants with clinically significant changes in vital signs from baseline
Number of participants with clinically significant changes in 12-lead ECG intervals from baseline
Proportion of participants achieving ACR50
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Experimental: sonelokimab dose | EXPERIMENTAL | All participants will receive sonelokimab subcutaneously every 4 weeks |
| Experimental: sonelokimab | EXPERIMENTAL | All participants will receive sonelokimab 120 mg Q4W for up to 2 years |
| sonelokimab | EXPERIMENTAL | 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 |
| sonelokimab dose with an induction regimen | EXPERIMENTAL | Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8. |
| sonelokimab dose without an induction regimen | EXPERIMENTAL | Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to this arm will receive placebo subcutaneously. |
| sonelokimab dose 1 with an induction regimen | EXPERIMENTAL | Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8. |
| sonelokimab dose 2 with an induction regimen | EXPERIMENTAL | Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8. |
| risankizumab | ACTIVE_COMPARATOR | Subjects randomized to this arm will receive risankizumab SC |
| sonelokimab dose regimen 1 | EXPERIMENTAL | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 |
| sonelokimab dose regimen 2 | EXPERIMENTAL | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 |
| sonelokimab dose regimen 3 | EXPERIMENTAL | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 |
| adalimumab | ACTIVE_COMPARATOR | Subjects randomized to this arm will receive adalimumab |
| sonelokimab dose 1 | EXPERIMENTAL | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. |
| sonelokimab dose 2 | EXPERIMENTAL | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. |
| Sonelokimab via a PFS | EXPERIMENTAL | - |
| Sonelokimab via an AI | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Sonelokimab | DRUG | Open-label |
| Placebo | DRUG | Randomized treatment, parallel-group |
| Risankizumab | DRUG | Active comparator |
| Adalimumab | DRUG | randomized treatment; parallel-group |
| Sonelokimab (M1095) | DRUG | randomized treatment; parallel-group |
Inclusion Criteria: 1. Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study. 2. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the pa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Eltrekibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
Sonelokimab is an investigational small molecule being developed for hidradenitis suppurativa and psoriatic arthritis. It is currently in Phase 3 clinical trials for psoriatic arthritis, including in patients naive to biologic disease-modifying antirheumatic drugs. The drug has received Fast Track designation from the FDA.
Sonelokimab targets and inhibits IL-17A and IL-17F, two inflammatory cytokines involved in autoimmune conditions. By blocking these targets, the drug aims to reduce inflammation in diseases like psoriatic arthritis and hidradenitis suppurativa.
Sonelokimab is being developed by MoonLake Immunotherapeutics, a biopharmaceutical company listed on the stock exchange under the ticker symbol MLTX. The company is conducting clinical trials for the drug in psoriatic arthritis and other inflammatory conditions.
Sonelokimab is in Phase 3 clinical development for psoriatic arthritis. It has completed a Phase 2 trial in active psoriatic arthritis and is currently in Phase 3 trials, including a long-term safety study. The drug is investigational and not yet approved by regulatory authorities.
Sonelokimab is being studied in several clinical trials. NCT06641076 is a Phase 3 trial in biologic-naive psoriatic arthritis patients. NCT07223138 is a Phase 3 long-term safety study. NCT05640245 was a completed Phase 2 trial in active psoriatic arthritis. NCT06994936 was a Phase 1 bioequivalence study.
Sonelokimab is a distinct investigational drug developed by MoonLake Immunotherapeutics. It is not known to be the same as any other marketed medication. Its unique mechanism targets both IL-17A and IL-17F, differentiating it from other therapies in development.