Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of efavaleukin alfa safety and effectiveness in adults with moderate to severe ulcerative colitis

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on studying a medication called efavaleukin alfa (also known as AMG 592) in people who have Ulcerative Colitis. Ulcerative Colitis is a long-term condition that causes inflammation and sores in the digestive tract, specifically affecting the large intestine and rectum, leading to symptoms such as abdominal pain, diarrhea, and bleeding.

The study aims to understand the long-term safety and effectiveness of efavaleukin alfa in treating people who have moderate to severe Ulcerative Colitis. This research is a continuation of a previous study, allowing researchers to gather information about how well the medication works and how safe it is when used for an extended period.

During this long-term extension study, participants will continue receiving efavaleukin alfa treatment for up to two years. Throughout this time, doctors will monitor various aspects of the participants' health, including how well their digestive system is healing and whether their symptoms are improving. They will also keep track of any side effects that may occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

    After completing the 52-week endoscopy in the parent study, you may continue treatment in this long-term extension study

    You will receive efavaleukin alfa treatment for an extended period to evaluate its long-term effects

  2. Step 2

    Treatment period

    The study will continue until May 31, 2028

    During this time, your condition will be monitored for any side effects or adverse reactions

    Regular assessments will check your response to the treatment

  3. Step 3

    52-week evaluation

    At week 52, you will undergo several evaluations:

    Assessment of your clinical response and remission status

    Examination of your intestinal lining through endoscopy

    Collection of tissue samples to check healing at microscopic level

    Evaluation of your symptoms

  4. Step 4

    104-week evaluation

    At week 104, the same evaluations will be repeated:

    Assessment of your clinical response and remission status

    Examination of your intestinal lining through endoscopy

    Collection of tissue samples to check healing at microscopic level

    Evaluation of your symptoms

  5. Step 5

    Ongoing monitoring

    Throughout the study, your use of corticosteroids will be monitored if you were receiving them at the start of the parent study

    Regular safety assessments will continue throughout the study period

    Changes in your condition will be tracked using specialized scoring systems

Who can join the trial?

6 criteria

  • Must be an adult aged 18 years or older
  • Must sign a document called informed consent before any study procedures begin (this is a form that explains all study details and patient rights)
  • Must have completed the week 52 examination with an endoscopy (a procedure where a small camera is used to look inside the digestive tract) in the previous phase 2 study
  • Must have been diagnosed with moderate to severe ulcerative colitis (a condition causing inflammation in the large intestine)
  • Can be either male or female
  • Must have previously participated in the phase 2 dose-finding study identified as study number 20170104

Who cannot join the trial?

13 criteria

  • Current or history of colonic dysplasia (abnormal cell growth in the colon) or cancer
  • Active or history of serious infections including tuberculosis
  • History of bowel surgery related to ulcerative colitis within the past 6 months
  • Presence of severe heart conditions or unstable heart disease
  • Current or recent treatment with other investigational drugs (within 30 days or 5 half-lives)
  • Known allergic reactions to similar medications
  • Severe liver disease or abnormal liver function tests
  • Pregnant or breastfeeding women
  • Active or chronic hepatitis B or C infection
  • History of cancer within the past 5 years (except treated non-melanoma skin cancer)
  • Severe kidney disease or significantly reduced kidney function
  • Current substance abuse or alcohol dependency
  • Any condition that, in the investigator's opinion, would compromise patient safety or study integrity
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Efavaleukin alfa is an investigational medication being studied for treating moderate to severe ulcerative colitis, which is a chronic inflammatory bowel disease. This medication is designed to help reduce inflammation in the intestines and improve symptoms in patients with ulcerative colitis. It works by modulating the immune system's response to help control the inflammation that causes damage to the intestinal lining.

What is already known about the treatment

Efavaleukin alfa - An investigational biological medication administered via subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of moderate to severe ulcerative colitis (UC). This novel therapeutic agent belongs to the class of immunomodulatory drugs and is designed to regulate immune system responses in patients with inflammatory bowel conditions. The medication works by targeting specific molecular pathways involved in the inflammatory process, potentially helping to reduce inflammation in the colon and improve symptoms of UC. Long-term safety and efficacy studies are ongoing to determine its potential as a treatment option for patients with UC 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 develops over time, with symptoms that can range from mild to severe, including abdominal pain, diarrhea, and rectal bleeding. The inflammation usually begins in the rectum and can spread continuously to involve other parts of the colon. UC is characterized by periods of active disease followed by periods of remission, where symptoms may temporarily disappear. The disease can affect people of any age, though it often begins in young adulthood.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506046-24-00Protocol code20210210Estimated enrolment140 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.