Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ANB030
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...
Top 20 of 31 competitors
Rosnilimab is an investigational monoclonal antibody being studied for the treatment of moderate to severe rheumatoid arthritis and moderate to severe ulcerative colitis. It is not yet approved for any indication and remains in clinical development. Both programs are currently in Phase 2 testing in adults 18 years and older.
Rosnilimab targets PD-1, a receptor that regulates immune cell activity. By binding PD-1, this monoclonal antibody is designed to modulate the immune response in inflammatory disease settings. Its target class is an antibody, and it is being developed for immunology indications including rheumatoid arthritis and ulcerative colitis.
Rosnilimab is being developed by AnaptysBio, Inc., which trades under the ticker ANAB. The company is running two Phase 2 clinical programs for the drug, one in rheumatoid arthritis and one in ulcerative colitis, across multiple countries in North America and Europe.
Rosnilimab is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any other regulatory agency. Two Phase 2 trials are ongoing, one in rheumatoid arthritis and one in ulcerative colitis, both currently active but not recruiting.
Rosnilimab is being evaluated in two Phase 2 trials. The RENOIR trial, NCT06041269, studies moderate to severe rheumatoid arthritis with 420 participants. The ROSETTA trial, NCT06127043, studies moderate to severe ulcerative colitis with 132 participants. Both are randomized, double-blind, placebo-controlled, and active but not recruiting.