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...
Sonelokimab is an investigational antibody being developed for hidradenitis suppurativa and psoriatic arthritis. It is currently in Phase 3 clinical trials for moderate to severe hidradenitis suppurativa. The drug is also being studied in adolescents with this condition.
Sonelokimab is being developed by MoonLake Immunotherapeutics, a biopharmaceutical company traded under the ticker MLTX. The company is conducting multiple clinical trials to evaluate the drug's efficacy and safety in inflammatory skin conditions.
Sonelokimab is in Phase 3 clinical development for hidradenitis suppurativa. Several Phase 3 trials have been completed, and one additional Phase 3 study is active but not recruiting participants. The drug has received Fast Track designation from the FDA.
Sonelokimab has been studied in several clinical trials, including NCT05322473, a Phase 2 trial in hidradenitis suppurativa, and NCT06411379 and NCT06411899, both Phase 3 trials in moderate to severe hidradenitis suppurativa. An ongoing Phase 3 trial, NCT06768671, is evaluating the drug in adolescents.
Sonelokimab is administered via subcutaneous injection in clinical trials. The Phase 3 studies evaluate subcutaneous sonelokimab compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The adolescent study also uses subcutaneous administration.
Yes, Sonelokimab is being studied in adolescents aged 12 years and older with moderate to severe hidradenitis suppurativa. The Phase 3 trial NCT06768671, known as VELA-TEEN, is an open-label, single-arm study evaluating the pharmacokinetics and safety of subcutaneous sonelokimab in this population.