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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03497897 | Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne | PHASE2 | COMPLETED | 66 | — | — | Sep 10, 2018 | Mar 9, 2022 | Aug 31, 2023 | 17 | United States, Czechia +4 |
Inflammatory facial lesion count included papules, pustules, and nodules. The natural log transformed inflammatory facial lesion count up to Week 12 was analyzed using a Bayesian mixed effect model for repeated measurements (MMRM). Values estimated from the model at Week 12 are presented in the table. Posterior geometric mean and 90% credible intervals in each group are presented.
| Arm | Type | Description |
|---|---|---|
| LYS006 20 mg BID | EXPERIMENTAL | LYS006, 20 mg, orally, twice daily (BID), for 12 weeks |
| LYS006 2 mg BID | EXPERIMENTAL | LYS006, 2 mg, orally, BID, for 12 weeks |
| Placebo BID | PLACEBO_COMPARATOR | Matching placebo, orally, BID, for 12 weeks |
| Name | Type | Description |
|---|---|---|
| LYS006 20 mg | DRUG | LYS006 20 mg, capsules, oral administration, BID, for 12 weeks |
| LYS006 2 mg | DRUG | LYS006 2 mg, capsules, oral administration, BID, for 12 weeks |
| Placebo | DRUG | Matching placebo, capsules, oral administration, BID, for 12 weeks |
Inclusion criteria: * Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening. * Body weight between 50 and 120 kg, both inclusive, at screening. * Patient...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 3 | PHASE3 | Ziltivekimab B, Ziltivekimab C, Ziltivekimab, Semaglutide Pen Injector |
| AstraZeneca PLC | AZN | 1 | — | Undisclosed |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Undisclosed |