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New drug rosnilimab aims to tame ulcerative colitis in Mid-Stage trial

NCT ID NCT06127043

Disease control Sponsor: AnaptysBio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called rosnilimab in 132 adults with moderate to severe ulcerative colitis. The goal is to see if it can reduce disease activity and improve symptoms compared to a placebo. Participants must have tried other treatments without success. The trial is active but not recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • AnaptysBio Investigational Site 10-103

    Kingsport, Tennessee, 37663, United States

  • AnaptysBio Investigational Site 10-104

    Dallas, Texas, 75246, United States

  • AnaptysBio Investigational Site 10-106

    Miami, Florida, 33165, United States

  • AnaptysBio Investigational Site 10-107

    Seattle, Washington, 98195, United States

  • AnaptysBio Investigational Site 10-108

    San Jose, California, 95124, United States

  • AnaptysBio Investigational Site 10-109

    Miami Gardens, Florida, 33014, United States

  • AnaptysBio Investigational Site 10-112

    Lancaster, California, 93534, United States

  • AnaptysBio Investigational Site 10-113

    Garland, Texas, 75044, United States

  • AnaptysBio Investigational Site 10-115

    Phoenix, Arizona, 85018, United States

  • AnaptysBio Investigational Site 10-117

    Garden Grove, California, 92845, United States

  • AnaptysBio Investigational Site 10-118

    Las Vegas, Nevada, 89128, United States

  • AnaptysBio Investigational Site 10-120

    Norman, Oklahoma, 73017, United States

  • AnaptysBio Investigational Site 10-122

    Atlanta, Georgia, 30328, United States

  • AnaptysBio Investigational Site 10-123

    Orlando, Florida, 32822, United States

  • AnaptysBio Investigational Site 10-124

    Oak Lawn, Illinois, 60453, United States

  • AnaptysBio Investigational Site 10-125

    Tampa, Florida, 33607, United States

  • AnaptysBio Investigational Site 10-127

    Brooksville, Florida, 34601, United States

  • AnaptysBio Investigational Site 10-129

    Lancaster, California, 93534, United States

  • AnaptysBio Investigational Site 10-130

    Southlake, Texas, 76092, United States

  • AnaptysBio Investigational Site 10-131

    Orlando, Florida, 32789, United States

  • AnaptysBio Investigational Site 10-132

    Tyler, Texas, 75701, United States

  • AnaptysBio Investigational Site 10-133

    Utica, New York, 13501, United States

  • AnaptysBio Investigational Site 10-134

    Lubbock, Texas, 79382, United States

  • AnaptysBio Investigational Site 10-135

    Georgetown, Texas, 78626, United States

  • AnaptysBio Investigational Site 10-136

    Cincinnati, Ohio, 45201, United States

  • AnaptysBio Investigational Site 11-102

    London, Ontario, Canada

  • AnaptysBio Investigational Site 11-103

    Montreal, Quebec, Canada

  • AnaptysBio Investigational Site 11-105

    Calgary, Canada

  • AnaptysBio Investigational Site 12-101

    Innsbruck, Austria

  • AnaptysBio Investigational Site 12-102

    Vienna, Austria

  • AnaptysBio Investigational Site 12-103

    Sankt Pölten, Austria

  • AnaptysBio Investigational Site 12-104

    Salzburg, Austria

  • AnaptysBio Investigational Site 16-101

    Tours, France

  • AnaptysBio Investigational Site 16-102

    Nantes, France

  • AnaptysBio Investigational Site 16-103

    Nantes, France

  • AnaptysBio Investigational Site 17-101

    Duisburg, Germany

  • AnaptysBio Investigational Site 17-103

    Kiel, Germany

  • AnaptysBio Investigational Site 17-105

    Dachau, Germany

  • AnaptysBio Investigational Site 17-106

    Brandenburg, Germany

  • AnaptysBio Investigational Site 17-107

    Berlin, Germany

  • AnaptysBio Investigational Site 17-108

    Hamburg, Germany

  • AnaptysBio Investigational Site 17-109

    Ulm, Germany

  • AnaptysBio Investigational Site 17-110

    Erlangen, Germany

  • AnaptysBio Investigational Site 20-102

    Rozzano, Italy

  • AnaptysBio Investigational Site 20-104

    San Giovanni, Italy

  • AnaptysBio Investigational Site 20-105

    Milan, Italy

  • AnaptysBio Investigational Site 20-106

    Udine, Italy

  • AnaptysBio Investigational Site 20-107

    Pavia, Italy

  • AnaptysBio Investigational Site 20-108

    Legnano, Italy

  • AnaptysBio Investigational Site 20-109

    San Donato, Italy

  • AnaptysBio Investigational Site 20-110

    Catania, Italy

  • AnaptysBio Investigational Site 20-111

    Cagliari, Italy

  • AnaptysBio Investigational Site 20-112

    Bologna, Italy

  • AnaptysBio Investigational Site 20-113

    Turin, Italy

  • AnaptysBio Investigational Site 21-101

    Amsterdam, Netherlands

  • AnaptysBio Investigational Site 24-102

    Alicante, Spain

  • AnaptysBio Investigational Site 24-103

    Lleida, Spain

  • AnaptysBio Investigational Site 27-101

    London, United Kingdom

  • AnaptysBio Investigational Site 27-102

    Cambridge, United Kingdom

  • AnaptysBio Investigational Site 27-103

    Belfast, United Kingdom

  • AnaptysBio Investigational Site 27-104

    York, United Kingdom

  • AnaptysBio Investigational Site 27-105

    Runcorn, United Kingdom

  • AnaptysBio Investigational Site 27-106

    Liverpool, United Kingdom

  • AnaptysBio Investigational Site 27-107

    Shrewsbury, United Kingdom

  • AnaptysBio Investigational Site 30-101

    Warsaw, Poland

  • AnaptysBio Investigational Site 30-101

    Bucharest, Romania

  • AnaptysBio Investigational Site 30-102

    Katowice, Poland

  • AnaptysBio Investigational Site 30-103

    Lodz, Poland

  • AnaptysBio Investigational Site 30-104

    Poznan, Poland

  • AnaptysBio Investigational Site 30-106

    Częstochowa, Poland

  • AnaptysBio Investigational Site 30-107

    Warsaw, Poland

  • AnaptysBio Investigational Site 30-108

    Bydgoszcz, Poland

  • AnaptysBio Investigational Site 30-109

    Warsaw, Poland

  • AnaptysBio Investigational Site 30-110

    Torun, Poland

  • AnaptysBio Investigational Site 30-111

    Krakow, Poland

  • AnaptysBio Investigational Site 30-112

    Elblag, Poland

  • AnaptysBio Investigational Site 30-113

    Sopot, Poland

  • AnaptysBio Investigational Site 30-114

    Lublin, Poland

  • AnaptysBio Investigational Site 30-115

    Katowice, Poland

  • AnaptysBio Investigational Site 30-116

    Rzeszów, Poland

  • AnaptysBio Investigational Site 30-117

    Poznan, Poland

  • AnaptysBio Investigational Site 30-119

    Lodz, Poland

  • AnaptysBio Investigational Site 30-120

    Poznan, Poland

  • AnaptysBio Investigational Site 30-123

    Krakow, Poland

  • AnaptysBio Investigational Site 31-102

    Timișoara, Romania

  • AnaptysBio Investigational Site 31-103

    Cluj-Napoca, Romania

  • AnaptysBio Investigational Site 58-101

    Belgrade, Serbia

  • AnaptysBio Investigational Site 58-102

    Zrenjanin, Serbia

  • AnaptysBio Investigational Site 58-103

    Belgrade, Serbia

  • AnaptysBio Investigational Site 58-104

    Belgrade, Serbia

  • AnaptysBio Investigational Site 58-105

    Belgrade, Serbia

  • AnaptysBio Investigational Site 59-101

    Tbilisi, Georgia, 0160, Georgia

  • AnaptysBio Investigational Site 59-102

    Tbilisi, 0141, Georgia

  • AnaptysBio Investigational Site 59-103

    Tbilisi, 0102, Georgia

  • AnaptysBio Investigational Site 59-104

    Tbilisi, 0160, Georgia

  • AnaptysBio Investigational Site 59-105

    Tbilisi, 0180, Georgia

  • AnaptysBio Investigational Site 59-106

    Tbilisi, 0101, Georgia

  • AnaptysBio Investigational Site 61-102

    Sofia, Bulgaria

  • AnaptysBio Investigational Site 74-101

    Zagreb, Croatia

  • AnaptysBio Investigational Site 74-104

    Rijeka, Croatia

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Other studies related to the condition(s) this trial covers.