ROSETTA
Summary
This study is being done to evaluate if rosnilimab is effective (producing a good result), tolerable and a safe therapy in subjects with moderate to severe UC.
The study will check if rosnilimab:
• Helps people feel better by relieving the symptoms of UC
• Is safe and well-tolerated by people taking it
• Is at the right amount in your blood to work properly
• Affects your immune system in a helpful way
• Doesn't cause unacceptable side effects
Rosnilimab is an experimental study drug substance called a humanized monoclonal antibody (antibody is a component of your immune response) that may help regulate (control or maintain) a portion of the immune system responsible for your condition and may be useful in treating people with UC. Rosnilimab is not marketed in any region or country.
The study is being carried out by AnaptysBio, Inc, who is the Sponsor of the study.
Eligibility
Eligible ages: 18 to 75
Inclusion criteria:
• Male or female who is ≥18 years
• Clinical diagnosis of UC for > 90 days prior to Day 1, including appropriate documentation of biopsy results that are consistent with UC, based on the assessment of the Investigator
• Moderate to severe active UC defined as a mMS ≥ 5 with an endoscopy
subscore ≥ 2 (based on a central reader review) at Baseline.
• Surveillance colonoscopy did not detect potential dysplasia or colon cancer performed within 1 year of Day 1
• Subject has completed at least 3 consecutive or 4 nonconsecutive eDiary entries within 7 days before Day 1 (excluding days during bowel preparation for endoscopy)
Exclusion criteria:
• Clinical diagnosis of Crohn’s disease, indeterminate colitis, fulminant colitis, and/or toxic megacolon
• Disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy
• History of colectomy, ileoanal pouch, Kock pouch, or ileostomy or is planning bowl surgery
• Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
• Clostridioides difficile infection within 30 days before Screening or a positive C. difficile toxin stool assay result at Screening, or infection with other intestinal pathogens within the 30 days before Screening
• Prior or current gastrointestinal (GI) dysplasia in any biopsy performed before or during the Screening endoscopy
• Evidence of colonic infection during Screening
• History of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes defined as, 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)
• Current treatment with any of the following:
o Oral corticosteroids equivalent to prednisone > 20 mg per day
o Oral corticosteroids equivalent to prednisone ≤ 20 mg per day that have been at a stable dose for < 4 weeks before Day 1
o Methotrexate or azathioprine
o Immunomodulatory biologic agents (including investigational biologics) received within 12 weeks or 5 half-lives (whichever is longer) immediately before Randomization.
o Live or live-attenuated vaccines within 12 weeks before the first dose of study drug.
o Fecal-microbial transplantation within 30 days prior to Day 1
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
Karen Graham
Principal investigator:
Remo Panaccione
Clinical trial:
Yes
REB-ID:
REB24-0215
External links