Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07007637 | A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | ENROLLING BY_INVITATION | 835 | — | — | Jun 27, 2025 | Jun 13, 2028 | Jun 8, 2026 | 166 | United States, Belgium +14 |
| NCT06768671 | An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN) | PHASE3 | ACTIVE NOT_RECRUITING | 35 | — | — | Dec 30, 2024 | Sep 28, 2026 | May 6, 2026 | 18 | United States |
| NCT06411899 | A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | COMPLETED | 422 | — | — | May 15, 2024 | May 14, 2026 | Jun 8, 2026 | 109 | United States, Bulgaria +8 |
| NCT06411379 | Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | COMPLETED | 418 | — | — | May 14, 2024 | May 20, 2026 | Jun 8, 2026 | 106 | United States, Belgium +10 |
| NCT05322473 | Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa | PHASE2 | COMPLETED | 234 | — | — | Apr 25, 2022 | Aug 30, 2023 | May 3, 2024 | 57 | United States, Bulgaria +5 |
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
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48 |
| 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. |
| adalimumab | ACTIVE_COMPARATOR | Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B. |
| Name | Type | Description |
|---|---|---|
| Sonelokimab | DRUG | Sonelokimab |
| Placebo | DRUG | Placebo |
| Sonelokimab (M1095) | DRUG | randomized treatment; parallel-group |
| Adalimumab | DRUG | randomized treatment; parallel-group |
Inclusion Criteria: * Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study. * Female participants are eligible to partic...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Lutikizumab, Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib, povorcitinib, Ruxolitinib, Vehicle |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab, Remibrutinib Dose A, Remibrutinib Dose B, CFZ533, LYS006 |
| MoonLake Immunotherapeutics Class A | MLTX | 4 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig, SAR445399 |
| Insmed Incorporated | INSM | 1 | PHASE2 | Brensocatib |
| 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 |