Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plonmarlimab · 2 trials · 2 indications
The change from baseline in the subject's self-assessed Visual Analogue Scale (VAS) score for pain intensity in the most severely affected joint at baseline, assessed at 72 hours after the initial dose.
| Arm | Type | Description |
|---|---|---|
| Plonmarlimab | EXPERIMENTAL | - |
| Group1-Plonmarlimab 3mg/kg | EXPERIMENTAL | Plonmarlimab 3mg/kg, Single dose, Intravenous infusion |
| Group2-Plonmarlimab 6mg/kg | EXPERIMENTAL | Plonmarlimab 6mg/kg, Single dose, Intravenous infusion |
| Group3-Compound betamethasone | ACTIVE_COMPARATOR | Compound betamethasone 7 mg, single dose, intramuscular injection |
| Name | Type | Description |
|---|---|---|
| Plonmarlimab | DRUG | Subjects will receive Plonmarlimab 10 mg/kg by intravenous injection once weekly from Week 1 to Week 3, and Plonmarlimab 6 mg/kg by intravenous injection once weekly from Week 4 to Week 8 (10 mg/kg QW×3 + 6 mg/kg QW×5). |
| Compound betamethasone | DRUG | single dose, intramuscular injection |
| Plonmarlimab placebo | DRUG | single dose, intravenous infusion |
| Compound betamethasone placebo | DRUG | single dose, intramuscular injection |
Inclusion Criteria: * Age: 16 to 80 years (inclusive), of any gender. * The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor subjects aged 16 years (inclusive) to less than 18 years, written informed consent must be signed by both the subjec...