Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sonelokimab (M1095), M1095
Sonelokimab · 9 trials · 2 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.
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
HiSCR75 was 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. A non-responder imputation (NRI) method was used for missing data.
| 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 (120 mg) | 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 (240 mg) | 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. |
| 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 monoclonal antibody being developed by MoonLake Immunotherapeutics for immunology indications. It is in Phase 3 clinical development for psoriatic arthritis and hidradenitis suppurativa. It has not been approved by the FDA and remains under clinical study.
Sonelokimab is being studied for the treatment of psoriatic arthritis and moderate to severe hidradenitis suppurativa. Phase 3 trials are evaluating it in adults with psoriatic arthritis, including patients with an inadequate response to anti-TNF therapy, and in adults and adolescents with hidradenitis suppurativa.
Sonelokimab targets both IL-17A and IL-17F, two cytokines involved in inflammatory signaling. By binding both cytokines, the antibody is designed to inhibit IL-17 pathway driven inflammation. This dual IL-17A and IL-17F targeting distinguishes it from antibodies that neutralize only IL-17A.
Sonelokimab is being developed by MoonLake Immunotherapeutics, which trades on the Nasdaq under the ticker MLTX. The company is running the Phase 3 clinical program for the antibody across psoriatic arthritis and hidradenitis suppurativa indications.
Sonelokimab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes trials in psoriatic arthritis and hidradenitis suppurativa, with both placebo-controlled and long-term extension designs.
Phase 3 trials include NCT07223138, a long-term study in psoriatic arthritis, NCT07007637, a long-term study in hidradenitis suppurativa, NCT06768671, the VELA-TEEN study in adolescents with hidradenitis suppurativa, and NCT06641089, which evaluates Sonelokimab in psoriatic arthritis patients with an inadequate response to anti-TNF therapy.
Yes, Sonelokimab is also known as M1095. Both names refer to the same investigational monoclonal antibody developed by MoonLake Immunotherapeutics. Readers searching for M1095 will find the same Phase 3 program in psoriatic arthritis and hidradenitis suppurativa.