Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rosnilimab · 2 trials · 2 indications
The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore.
The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints
| Arm | Type | Description |
|---|---|---|
| Rosnilimab SC Dose 1 | EXPERIMENTAL | This arm will receive High dose Rosnilimab SC |
| Rosnilimab SC Dose 2 | EXPERIMENTAL | This arm will receive low dose Rosnilimab SC |
| Placebo | PLACEBO_COMPARATOR | This arm will receive Placebo SC |
| Rosnilimab SC Dose 3 | EXPERIMENTAL | This arm will receive treatment SC |
| Name | Type | Description |
|---|---|---|
| Rosnilimab | DRUG | PD-1 agonist antibody |
| Placebo | DRUG | Administered via SC |
Inclusion Criteria: * Male or female ≥18 * Participants with a clinical diagnosis of UC for prior to Day 1 * Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2 * Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon ca...
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