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

The ROSETTA study is a global study assessing the safety and effectiveness of two different doses of the investigational study medicine rosnilimab, compared to placebo, for adults with moderate to severe ulcerative colitis. 

The duration of the study is approximately 24 weeks, followed by a 10-week follow-up period.  

Study participants will receive four (4) subcutaneous injections every 2 weeks. 

Description of treatment or intervention (mechanism of action): 

Rosnilimab (ANB030) is a humanized monoclonal antibody that binds to PD-1 receptors on immune cells.   

PD-1 signaling is known to play a role in decreasing inflammatory responses characteristic of Ulcerative Colitis.  

Rosnilimab (ANB030) is administered by subcutaneous injection in the upper arm, thigh, or abdomen. 

Participation requirements: 

• Come to all study visit appointments. 

• Complete a diary and bring it with you to appointments. 

• Tell the study doctor/staff about any health problems you experience during the study. 

• Tell the study staff about any medication changes, or new medicines you take during the study, including over-the-counter drugs. 

Possible risks and side effects: 

      Because we are learning about the study medicine, all possible side effects and risks related to the study medicine are not known and there is the potential that you may experience side effects. Side effects may range from mild and unpleasant to serious, or even life-threatening. 

      If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored.