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

Ulcerative Colitis Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127043
• Other study ID #: ANB030-204 ROSETTA
• Status: Recruiting
• Phase: Phase 2
• Start date: December 4, 2023
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: AnaptysBio, Inc.
• Contact: AnaptysBio Inc.
• Phone: (858)362-6295
• Email: clinicaltrialinfo[@]anaptysbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: May 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Rosnilimab
PD-1 agonist antibody
• Placebo
Administered via SC

Locations

Country	Name	City	State
Georgia	AnaptysBio Investigative Site 59-101	Tbilisi
Georgia	AnaptysBio Investigative Site 59-102	Tbilisi
Georgia	AnaptysBio Investigative Site 59-103	Tbilisi
Georgia	AnaptysBio Investigative Site 59-104	Tbilisi
Georgia	AnaptysBio Investigative Site 59-105	Tbilisi
Georgia	AnaptysBio Investigative Site 59-106	Tbilisi
United States	AnaptysBio Investigative Site 10-104	Dallas	Texas
United States	AnaptysBio Investigative Site 10-117	Garden Grove	California
United States	AnaptysBio Investigative Site 10-113	Garland	Texas
United States	AnaptysBio Investigative Site 10-119	Hagerstown	Maryland
United States	AnaptysBio Investigative Site 10-121	Hamden	Connecticut
United States	AnaptysBio Investigative Site 10-103	Kingsport	Tennessee
United States	AnaptysBio Investigative Site 10-101	Kissimmee	Florida
United States	AnaptysBio Investigative Site 10-112	Lancaster	California
United States	AnaptysBio Investigative Site 10-118	Las Vegas	Nevada
United States	AnaptysBio Investigative Site 10-110	Los Angeles	California
United States	AnaptysBio Investigative Site 10-106	Miami	Florida
United States	AnaptysBio Investigative Site 10-109	Miami Gardens	Florida
United States	AnaptysBio Investigative Site 10-120	Norman	Oklahoma
United States	AnaptysBio Investigative Site 10-115	Phoenix	Arizona
United States	AnaptysBio Investigative Site 10-108	San Jose	California
United States	AnaptysBio Investigative Site 10-107	Seattle	Washington
United States	AnaptysBio Investigative Site 10-114	Sun City	Arizona
United States	AnaptysBio Investigative Site 10-102	Tampa	Florida
United States	AnaptysBio Investigative Site 10-105	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in modified Mayo Score (mMs) from 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.	Baseline to Week 12
Secondary	Proportion of subjects achieving clinical remission at Week 12	Defined as a mMS = 2, with a stool frequency subscore (SFS) = 1, RBS=0, and endoscopic subscore = 1 without friability.	Baseline to Week 12
Secondary	Proportion of subjects showing endoscopic treatment improvement at Week 12	Defined as an endoscopy subscore = 1 without friability.	Baseline to Week 12
Secondary	Proportion of subjects achieving a clinical response at 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.	Baseline to Week 12