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Evaluating Rosnilimab for Moderate to Severe Ulcerative Colitis

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

Phase 2 Interventional AnaptysBio, Inc. · NCT06127043

This study is testing if Rosnilimab can help people with moderate to severe ulcerative colitis feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years and up
SexAll
SponsorAnaptysBio, Inc. Industry-sponsored
Drugs / interventionsadalimumab, golimumab, infliximab, ustekinumab, vedolizumab, tofacitinib, upadacitinib, Rosnilimab
Locations100 sites (Phoenix, Arizona and 99 other locations)
Trial IDNCT06127043 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, and efficacy of Rosnilimab in patients with moderate to severe ulcerative colitis. It is a Phase 2, randomized, double-blind, placebo-controlled trial involving multiple centers. Participants will receive either Rosnilimab or a placebo, and the study will measure various outcomes including pharmacokinetics and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of moderate to severe ulcerative colitis who have not responded adequately to previous treatments.

Not a fit: Patients with Crohn's disease, indeterminate colitis, or those who have had inadequate responses to multiple advanced UC therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate to severe ulcerative colitis.

How similar studies have performed: Other studies have shown promise with similar PD-1 agonist approaches, but this specific application of Rosnilimab is novel.

Eligibility criteria

Show full inclusion / exclusion 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.
* Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 UC therapy classes defined as, but not limited to, aminosalicylates, corticosteroids, immunomodulators, calcineurin inhibitors, or advanced UC therapies (e.g., biologics, JAK inhibitors, oral S1P receptor modulators, etc.)

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.

Where this trial is running

Phoenix, Arizona and 99 other locations

+50 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisRosnilimabANB030PD-1 agonistROSETTA
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.