Ulcerative Colitis
Conditions
Keywords
Rosnilimab, ANB030, PD-1 agonist, ROSETTA
Brief summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).
Interventions
DRUGRosnilimab
PD-1 agonist antibody
DRUGPlacebo
Administered via SC
Sponsors
AnaptysBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 cancer performed within 1 year of Day 1. * Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 UC therapy classes defined as, but not limited to, aminosalicylates, corticosteroids, immunomodulators, calcineurin inhibitors, or advanced UC therapies (e.g., biologics, JAK inhibitors, oral S1P receptor modulators, etc.)
Exclusion criteria
* Subject has a diagnosis of Crohn's disease or indeterminate colitis. * Subject has a diagnosis of fulminant colitis and/or toxic megacolon. * Subject has a history of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes but not limited to, 1) anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), 2) other biologics (e.g., ustekinumab, vedolizumab), 3) oral JAK inhibitors (e.g., tofacitinib, upadacitinib), and 4) oral S1P receptor modulators (e.g., ozanimod). * Subject has disease limited to the rectum (ulcerative proctitis) * Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery. * The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in modified Mayo Score (mMs) from Baseline to Week 12 | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving clinical remission at Week 12 | Baseline to Week 12 | Defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS=0, and endoscopic subscore ≤ 1 without friability. |
| Proportion of subjects showing endoscopic treatment improvement at Week 12 | Baseline to Week 12 | Defined as an endoscopy subscore ≤ 1 without friability. |
| Proportion of subjects achieving a clinical response at Week 12 | Baseline to Week 12 | Defined as a decrease from Baseline in mMS ≥ 2 points and ≥ 30% with a decrease from Baseline in RBS ≥ 1 point or an absolute RBS ≤ 1. |
Countries
Austria, Bulgaria, Canada, Croatia, France, Georgia, Germany, Italy, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom, United States
Outcome results
None listed