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NCT06127043Recruiting

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

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
AnaptysBio, Inc.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Rosnilimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AnaptysBio, Inc.
Location
Kissimmee,Tampa,Winston-Salem,Kingsport,Dallas, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 04, 2023
End date
May 01, 2026
Enrollment
132 participants
Primary outcome

Mean change in modified Mayo Score (mMs) from Baseline to Week 12

Summary

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

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06127043
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06127043 through Pure Global AI's free database. This Phase 2 trial is sponsored by AnaptysBio, Inc. and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 132 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.