Testing efavaleukin alfa’s effect on moderately to severely active ulcerative colitis

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    What is this study about?

    This trial is about a drug named efavaleukin alfa, which might be helpful for people suffering from ulcerative colitis. Participants will either receive one of three doses of this drug or placebo for 12 weeks. If the treatment works, participants can choose to continue it for up to 52 weeks. If initially received placebo didn’t work, treatment will be switched to efavaleukin alfa.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Innsbruck , Austria

      Salzburg , Austria

      Wien , Austria

      Edegem , Belgium

      Leuven , Belgium

      Liu00e8ge , Belgium

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Hradec Kralove , Czechia

      Praha , Czechia

      Herlev , Denmark

      Kobenhavn NV , Denmark

      Helsinki , Finland

      Amiens cedex 1 , France

      Montpellier cedex 5 , France

      Nice cedex 3 , France

      Saint Priest en Jarez , France

      Essen , Germany

      Frankfurt am Main , Germany

      Kiel , Germany

      Ulm , Germany

      Alexandroupoli , Greece

      Athens , Greece

      Athens , Greece

      Haidari , Greece

      Heraklion , Greece

      Heraklion , Greece

      Ioannina , Greece

      Patras , Greece

      Bekescsaba , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Szeged , Hungary

      Tatabanya , Hungary

      Brescia , Italy

      Catanzaro , Italy

      Firenze , Italy

      Genoa , Italy

      Milano , Italy

      Milano , Italy

      Negrar VR , Italy

      Roma , Italy

      Leiden , Netherlands

      Tilburg , Netherlands

      Utrecht , Netherlands

      Elblag , Poland

      Lodz , Poland

      Malbork , Poland

      Poznan , Poland

      Skorzewo , Poland

      Warszawa , Poland

      Wroclaw-Krzyki , Poland

      Wroclaw , Poland

      Bucharest , Romania

      Bucuresti , Romania

      Bucuresti , Romania

      Bucuresti , Romania

      Bucuresti , Romania

      Oradea , Romania

      Banska Bystrica , Slovakia

      Kosice , Slovakia

      Presov , Slovakia

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      You can join this study in:

      Greece: Alexandroupolis, Haidari, Heraklion, Ioannina, Patras.

      Slovakia: Banská Bystrica.

      Spain: Barcelona, Madrid.

      Italy: Brescia, Catanzaro, Genoa.

      Romania: Bucharest, Oradea.

      Hungary: Budapest, Szeged, Tatabánya.

      Belgium: Edegem, Leuven.

      Poland: Elbląg, Łódź, Malbork, Poznań, Skórzewo, Wrocław.

      Germany: Essen, Kiel, Ulm.

      Finland: Helsinki.

      Denmark: Herlev.

      Czechia: Hradec Králové.

      Austria: Innsbruck, Salzburg.

      Netherlands: Leiden, Tilburg, Utrecht.

      Bulgaria: Sofia.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps that a patient needs to take in this clinical trial are as follows:

      1. Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period.
      2. If a participant completes the 12-week induction period, they may have the option to enter an exploratory long-term treatment period for up to 40 weeks, contingent on the investigator’s opinion of potential benefit from continued treatment.
      3. During the long-term period:
        1. Participants randomized to efavaleukin alfa will remain on the same blinded dose of efavaleukin alfa.
        2. Participants randomized to placebo who achieved a clinical response at week 12 will remain on placebo.
        3. Placebo non-responders, i.e., those who did not achieve clinical response at week 12, will receive efavaleukin alfa in a blinded manner during continued treatment.
      4. All participants will complete a safety follow-up visit 6 weeks after their last dose of the investigational product.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the clinical trial, the disease condition you need to have is Ulcerative Colitis (UC) established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following Inclusion Criteria:

      1. Inadequate response, loss of response, or intolerance to therapies: You must have had an inadequate response, loss of response, or intolerance to at least one treatment which includes conventional therapy, biologic therapy, or targeted small molecule therapy (such as Janus kinase [JAK] inhibitors or S1P modulators). This means that these treatments have previously been ineffective, stopped working after a period, or caused you to experience unacceptable side effects.
      2. Corticosteroid-refractory or dependent colitis: You have struggled with colitis that is either resistant to corticosteroid therapy (despite using a minimum of 30 mg/day of oral prednisone or equivalent for at least 2 weeks) or you have become dependent on corticosteroids (unable to reduce below prednisone 10 mg/day within 3 months of starting corticosteroids without symptoms returning or relapsing within 3 months of completing corticosteroids).
      3. Intolerance to corticosteroids or immunomodulators: If you have had side effects such as Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, or neuropsychiatric effects including insomnia due to corticosteroid treatment, or nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia due to immunomodulators, and you have not failed or shown intolerance to a biological medication for the treatment of ulcerative colitis.
      4. Persistent ulcerative colitis (UC) symptoms despite immunomodulators: You have symptoms of active UC despite at least 3 months’ treatment with immunomodulators at approved doses such as azathioprine or 6-mercaptopurine, or a combination of thiopurine and allopurinol.
      5. Inadequate response to biologic or targeted small molecule therapy: If you’ve used biologic or targeted small molecule therapies that are approved in your country for the treatment of UC and have had persistent symptoms despite following the approved treatment regimen or a return of symptoms while on maintenance doses after initially responding to treatment.
      6. Stably dosed prior therapies: If you’re currently receiving any treatments like 5-aminosalicylates (ASAs), oral corticosteroids, budesonide, beclomethasone dipropionate, or conventional immunomodulators, your dosage must be stable for a specific duration before the screening endoscopy.

      Here are explanations for some medical terms used:

      Janus kinase (JAK) inhibitors: A class of medication that blocks the activity of one or more of the Janus kinase family of enzymes, interfering with the JAK-STAT signaling pathway.
      S1P modulators: These drugs modulate the activity of sphingosine-1-phosphate (S1P) receptors which play a role in immunology and are used to treat certain autoimmune diseases.
      Corticosteroids: A class of steroid hormones used to reduce inflammation.
      Corticosteroid-refractory: Condition in which corticosteroids are unable to alleviate disease symptoms.
      Corticosteroid-dependent: A situation where the patient can’t discontinue corticosteroids without a relapse of symptoms.
      Immunomodulators: Drugs that help regulate or normalize the immune system.
      5-aminosalicylates (ASAs): Medications typically used to treat inflammatory bowel diseases like UC.
      Budesonide: A corticosteroid with a high topical anti-inflammatory effect used in the treatment of UC.
      Thiopurines: A class of immunosuppressive drugs that include azathioprine and 6-mercaptopurine. They are used to maintain remission in chronic conditions like UC.

      What Reasons Could Exclude Me from the Study?

      Key Exclusion Criteria and Explanations:

      1. Crohn’s disease and other non-UC bowel diseases: If you have been diagnosed with Crohn’s disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or have clinical findings that suggest Crohn’s disease, you cannot participate.
      2. Toxic megacolon, fulminant colitis, abscess, or stricture/stenosis: Evidence of severe conditions like toxic megacolon (rapidly widening colon), fulminant colitis (severe inflammation of the colon), intra-abdominal abscess (a pocket of pus in the abdominal cavity), or narrowing/blockage in the small bowel or colon.
      3. Extensive surgery for UC: If you have had significant surgery for Ulcerative Colitis (UC), such as a subtotal colectomy (removal of part of the colon), or are likely to need such surgery during the study.
      4. T cell depleting agents: If you are currently receiving or have been treated within the past 12 months with T cell depleting agents like antithymocyte globulin or Campath (alemtuzumab), which are drugs that reduce the number of T cells that play a role in immune response.
      5. Recent therapy with specific medications: If you have received certain medications within specified time frames before screening rectosigmoidoscopy (an exam of the rectum and the lower part of the colon):
        • Anti-TNF antibodies: Such as infliximab, adalimumab, golimumab less than 8 weeks prior.
        • Anti-integrin antibodies: Like vedolizumab, less than 8 weeks prior.
        • IL 12/23 antagonists: For example, ustekinumab, less than 8 weeks prior.
        • JAK inhibitors: Such as tofacitinib, less than 4 weeks prior.
        • Other approved biologic agents or small molecules: Less than 8 weeks prior or less than 5 half-lives of the drug, whichever is longer.
        • Immunomodulators: Including oral or intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide less than 4 weeks prior.
        • Investigational biologic therapy: Within 8 weeks prior or less than 5 half-lives prior.
      6. Apheresis: If you have used apheresis (a procedure to remove certain blood components) less than 2 weeks prior to screening rectosigmoidoscopy.

      These are the main reasons you might be excluded from participating in the study. If any of these conditions apply to you, it is likely you would not be eligible to take part in the clinical trial.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the clinical study are:

      1. Efavaleukin alfa (also known as AMG 592) – This active substance is administered by subcutaneous (SC) injection. Efavaleukin alfa is being tested in three different doses across three experimental arms of the study, all of which involve administration once every two weeks (Q2W). It is a therapeutic agent under investigation for its potential use in treating various autoimmune diseases, including ulcerative colitis in this clinical trial.
      2. Placebo – The placebo is also administered by SC injection on the same schedule as the active drug, once every two weeks (Q2W). It is used as a comparator to evaluate the efficacy of the experimental drug, efavaleukin alfa.

      A brief description of the active substance, excluding the placebo as it does not contain an active substance, is as follows:

      Efavaleukin alfa (AMG 592) – Efavaleukin alfa is an experimental drug being tested for its effectiveness and safety in participants with moderately to severely active ulcerative colitis. It is administered through subcutaneous injections. Although the exact mechanism of action for this compound in ulcerative colitis is not detailed in the provided document, drugs in development for autoimmune conditions typically aim to modulate the immune system to reduce inflammation and autoimmune activity.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being evaluated in the clinical trial is efavaleukin alfa, also known as AMG 592. The study is focused on assessing the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).

      List of substances involved in the clinical trial:

      1. Efavaleukin alfa (AMG 592): This drug is currently being tested for its efficacy in ulcerative colitis. Participants in the clinical trial will be administered efavaleukin alfa by subcutaneous injection. They will receive one of three different doses of efavaleukin alfa, or a placebo, during a 12-week induction period. Those who benefit may continue treatment in an exploratory long-term period for up to 52 weeks in total. The trial aims to determine whether efavaleukin alfa can induce clinical remission in the target patient population.

      The document provided does not include specific information on whether efavaleukin alfa is already known to medicine and the medical literature outside of the context of this clinical trial. Further research in medical literature databases and sources would be necessary to determine its prior knowledge.


      Study ID

      CT-EU-00041646

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      II

      Medicinal Product