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Study of Efavaleukin Alfa to Treat Adults 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 study examines a treatment for patients with Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The study tests a new medication called efavaleukin alfa in people who have moderate to severe forms of the disease and haven't responded well enough to previous treatments. The medication will be compared to placebo to determine if it can help patients achieve remission, which means a reduction in disease symptoms.

The study involves patients taking either efavaleukin alfa or placebo while continuing their current medications such as 5-aminosalicylates, corticosteroids, budesonide, beclomethasone dipropionate, or other immune system medications like azathioprine, 6-mercaptopurine, or methotrexate. The main purpose is to evaluate if efavaleukin alfa can help patients achieve clinical remission after 12 weeks of treatment.

During the study, doctors will monitor how well the treatment works by examining the digestive tract and checking for improvements in symptoms. They will also keep track of any side effects that may occur. The study is designed as a double-blind study, which means neither the patients nor the doctors know who is receiving the actual medication or the placebo during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    The clinical trial focuses on patients with moderately to severely active ulcerative colitis (UC)

    Your UC diagnosis must be confirmed at least 3 months before joining the study

    Your condition will be evaluated using a modified Mayo score between 5 to 9, including an endoscopy examination

  2. Step 2

    Medication history verification

    Your previous treatments must show inadequate response, loss of response, or intolerance to at least one conventional therapy, biologic therapy, or targeted small molecule therapy

    If you are taking any of these medications, they must be at stable doses:

    - Oral 5-aminosalicylates (stable for at least 2 weeks)

    - Oral corticosteroids (20mg/day or less of prednisone, stable for at least 2 weeks)

    - Budesonide (9mg/day, stable for at least 2 weeks)

    - Beclomethasone dipropionate (5mg/day, stable for at least 2 weeks)

    - Immunomodulators (azathioprine, 6-mercaptopurine, methotrexate - stable for at least 12 weeks)

  3. Step 3

    Treatment period

    The study medication is called efavaleukin alfa

    You will receive either the study medication or a placebo

    The treatment period lasts for 12 weeks

  4. Step 4

    Evaluation of results

    At week 12, your condition will be evaluated for:

    - Clinical remission (main goal)

    - Clinical response

    - Endoscopic examination results

    - Symptoms improvement

    - Colon tissue examination

    Any side effects will be monitored throughout the study

Who can join the trial?

10 criteria

  • You must sign an informed consent form before any study procedures begin
  • You must have been diagnosed with Ulcerative Colitis (UC) for at least 3 months before joining the study, confirmed by clinical examination, endoscopy, and tissue analysis
  • You must have moderate to severe UC with a modified Mayo score between 5 and 9 (a scoring system that measures disease activity) and an endoscopy score of 2 or higher
  • You must have previously tried at least one standard treatment, biological therapy, or JAK-inhibitor (a type of medication) that either didn't work well enough or caused side effects
  • If you are taking any of these medications, the doses must be stable:
    • 5-aminosalicylates (stable for at least 2 weeks)
    • Oral steroids (no more than 20mg/day prednisone, stable for at least 2 weeks)
    • Budesonide (9mg/day, stable for at least 2 weeks)
    • Beclomethasone dipropionate (5mg/day, stable for at least 2 weeks)
    • Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate - stable for at least 12 weeks)
    • You must be between 18 and 79 years old (19-79 years old in South Korea)

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to any medications
  • Active or chronic infections, including tuberculosis (TB), hepatitis B, or hepatitis C
  • Current or recent treatment with other biological medications (special types of drugs that affect the immune system) within the past 3 months
  • Cancer diagnosis or treatment within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Severe heart conditions or uncontrolled high blood pressure
  • Major surgery within 8 weeks before starting the study
  • Participation in another clinical trial within the past 30 days
  • Current pregnancy or breastfeeding
  • History of bowel surgery related to ulcerative colitis
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Use of prohibited medications including live vaccines within 4 weeks before the study
  • Mental health conditions that could interfere with study participation
  • Drug or alcohol abuse within the past 6 months
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Investigated drugs

Efavaleukin alfa is an experimental medication being studied for treating ulcerative colitis, which is an inflammatory bowel disease. This medication is designed to help reduce inflammation in the intestines and induce remission in patients with moderate to severe ulcerative colitis. It works by modulating the immune system to help control the inflammatory response that causes symptoms of ulcerative colitis.

What is already known about the treatment

Efavaleukin alfa – An investigational biological medication administered via injection that is currently being studied in Phase 2 clinical trials for the treatment of moderately to severely active Ulcerative Colitis. This novel therapeutic agent belongs to the class of immunomodulatory drugs and works by modifying the activity of interleukin pathways in the immune system to reduce inflammation in the digestive tract. The medication is being evaluated for its ability to induce clinical remission in patients with UC, representing a potential new treatment option for those who have not responded adequately to conventional therapies.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The condition typically begins in the rectum and lower colon but may spread continuously to involve the entire colon. Symptoms develop gradually and can include recurring diarrhea with blood or mucus, abdominal pain, and urgent bowel movements. The disease usually follows a pattern of periodic flare-ups alternating with periods of remission. UC is an autoimmune condition where the immune system mistakenly attacks the body's own tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506004-93-00Protocol code20170104Estimated enrolment329 patientsSponsorAmgen Inc.

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