A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

Key facts

Study ID

NCT06127043

Run by

AnaptysBio, Inc.

People needed

132

Starts

2023-12-04

Expected to finish

2026-05-01

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• AnaptysBio Investigational Site 11-105 — Calgary, Canada
• AnaptysBio Investigational Site 74-104 — Rijeka, Croatia
• AnaptysBio Investigational Site 74-101 — Zagreb, Croatia
• AnaptysBio Investigational Site 16-102 — Nantes, France
• AnaptysBio Investigational Site 16-103 — Nantes, France
• AnaptysBio Investigational Site 16-101 — Tours, France
• AnaptysBio Investigational Site 59-101 — Tbilisi, Georgia, Georgia
• AnaptysBio Investigational Site 59-106 — Tbilisi, Georgia
• AnaptysBio Investigational Site 59-103 — Tbilisi, Georgia
• AnaptysBio Investigational Site 59-102 — Tbilisi, Georgia
• AnaptysBio Investigational Site 59-104 — Tbilisi, Georgia
• AnaptysBio Investigational Site 59-105 — Tbilisi, Georgia
• AnaptysBio Investigational Site 17-107 — Berlin, Germany
• AnaptysBio Investigational Site 17-106 — Brandenburg, Germany
• AnaptysBio Investigational Site 17-105 — Dachau, Germany
• AnaptysBio Investigational Site 17-101 — Duisburg, Germany
• AnaptysBio Investigational Site 17-110 — Erlangen, Germany
• AnaptysBio Investigational Site 17-108 — Hamburg, Germany
• AnaptysBio Investigational Site 17-103 — Kiel, Germany
• AnaptysBio Investigational Site 17-109 — Ulm, Germany
• AnaptysBio Investigational Site 20-112 — Bologna, Italy
• AnaptysBio Investigational Site 20-111 — Cagliari, Italy
• AnaptysBio Investigational Site 20-110 — Catania, Italy
• AnaptysBio Investigational Site 20-108 — Legnano, Italy
• AnaptysBio Investigational Site 11-103 — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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