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Study on the Effectiveness and Safety of Rosnilimab for Patients with Moderate to Severe Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Ulcerative Colitis, a condition that causes inflammation and sores in the lining of the large intestine. The treatment being tested is called Rosnilimab, which is given as a solution for injection. The study aims to evaluate how effective and safe Rosnilimab is for people with moderate to severe forms of this disease. Participants in the study will receive either Rosnilimab or a placebo, which is a substance with no active medication, to compare the outcomes.

The study will take place over several weeks, during which participants will receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment. The goal is to see if Rosnilimab can help reduce the symptoms of Ulcerative Colitis and improve the quality of life for those affected by this condition. Throughout the study, participants will be closely monitored for any changes in their condition and any potential side effects of the treatment.

By participating in this trial, researchers hope to gather important information that could lead to better treatment options for people with Ulcerative Colitis. The study is designed to ensure the safety and well-being of all participants while providing valuable insights into the potential benefits of Rosnilimab for managing this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of ulcerative colitis, and previous treatment history.

    A surveillance colonoscopy must have been performed within one year prior to the start of the study to rule out dysplasia or colon cancer.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish baseline measurements. This includes a review of medical history and current symptoms.

    Participants are required to complete electronic diary entries to document symptoms and bowel movements.

  3. Step 3

    Treatment administration

    Participants receive either rosnilimab or a placebo. Rosnilimab is administered as a solution for injection under the skin (subcutaneous).

    The frequency and dosage of the injections are determined by the study protocol and are administered regularly throughout the trial.

  4. Step 4

    Ongoing assessments

    Regular assessments are conducted to monitor the effectiveness and safety of the treatment. This includes measuring changes in symptoms and conducting endoscopic evaluations.

    Participants are monitored for any side effects or adverse events, and adjustments to the treatment may be made if necessary.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a final evaluation is conducted to assess the overall impact of the treatment on ulcerative colitis symptoms.

    This includes a comprehensive review of all collected data, including symptom diaries, endoscopic results, and any side effects experienced.

  6. Step 6

    Follow-up

    Participants may be required to attend follow-up visits to monitor long-term effects and gather additional data on the treatment's impact.

    These visits help ensure the continued safety and well-being of participants after the trial concludes.

Who can join the trial?

9 criteria

  • Must be a male or female who is **18 years** or older.
  • Must have a clinical diagnosis of **Ulcerative Colitis (UC)** for more than 90 days before the start of the study. This includes having biopsy results that confirm UC, as assessed by the study doctor.
  • Must have **moderate to severe active UC**, which means a specific score of 5 or more on a test called mMS, with an endoscopy subscore of 2 or more, as reviewed by a central reader at the start of the study.
  • Must have had a **surveillance colonoscopy** within one year before the study start date, which did not find any potential dysplasia (abnormal cells) or colon cancer.
  • Must have completed at least 3 consecutive or 4 nonconsecutive entries in an **eDiary** (an electronic diary) within 7 days before the study start date, not counting days when preparing for an endoscopy.
  • Must have a history of not responding well, losing response, or not tolerating at least two different types of standard UC treatments. These treatments include:
    • **Aminosalicylates** (e.g., sulfasalazine, mesalamine)
    • **Corticosteroids** (e.g., prednisone, budesonide, dexamethasone)
    • **Immunosuppressants** (e.g., azathioprine, methotrexate)
    • **Calcineurin inhibitors** (e.g., cyclosporine, tacrolimus)

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of certain liver or kidney problems.
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Investigated drugs

Rosnilimab is a medication being studied for its potential to help people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. The trial aims to see how well this medication works in reducing the symptoms of ulcerative colitis and improving the overall health of the colon.

What is already known about the treatment

Rosnilimab – Rosnilimab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness in treating moderate to severe ulcerative colitis. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for rosnilimab is ulcerative colitis, a chronic inflammatory condition of the colon. At the molecular level, rosnilimab works by targeting specific pathways in the immune system to reduce inflammation. It is classified pharmacologically as an immunomodulator, which means it helps regulate or normalize the immune system.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. Over time, the inflammation can cause the colon to become less effective at absorbing water and nutrients, leading to further complications. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut. Environmental factors, genetics, and an imbalance in gut bacteria may also play a role in its development.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508679-34-00Protocol codeANB030-204Estimated enrolment132 patientsSponsorAnaptysbio Inc.

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