Status:
ACTIVE_NOT_RECRUITING
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
Lead Sponsor:
AnaptysBio, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 imm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06127043
Start Date
December 4 2023
End Date
May 1 2026
Last Update
October 3 2025
Active Locations (100)
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1
AnaptysBio Investigational Site 10-115
Phoenix, Arizona, United States, 85018
2
AnaptysBio Investigational Site 10-117
Garden Grove, California, United States, 92845
3
AnaptysBio Investigational Site 10-112
Lancaster, California, United States, 93534
4
AnaptysBio Investigational Site 10-129
Lancaster, California, United States, 93534