A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
Study Details
Study Description
Brief Summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rosnilimab SC Dose 1 This arm will receive treatment SC |
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
|
| Experimental: Rosnilimab SC Dose 2 This arm will receive treatment SC |
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
|
| Placebo Comparator: Placebo This arm will receive Placebo SC |
Drug: Placebo
Administered via SC
|
Outcome Measures
Primary Outcome Measures
- Mean change in mMS from Baseline to Week 12 [Baseline to Week 12]
The mMS is an endoscopic and clinical scale used to assess the UC disease activity. It consists of three subscores: RBS, SFS, and an endoscopy subscore.
Secondary Outcome Measures
- Proportion of subjects achieving clinical remission at Week 12 [Baseline to Week 12]
Defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS=0, and endoscopic subscore ≤ 1 without friability.
- Proportion of subjects showing endoscopic treatment improvement at Week 12 [Baseline to Week 12]
Defined as an endoscopy subscore ≤ 1 without friability.
- Proportion of subjects achieving a clinical response at Week 12 [Baseline to 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.
Eligibility Criteria
Criteria
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.
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Subject has a diagnosis of fulminant colitis and/or toxic megacolon.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AnaptysBio Investigative Site 10-101 | Kissimmee | Florida | United States | 34741 |
Sponsors and Collaborators
- AnaptysBio, Inc.
Investigators
- Study Director: Zurab Machaidze, MD, AnaptysBio, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANB030-204 ROSETTA