Study of Efavaleukin Alfa to Treat Adults with Moderate to Severe Ulcerative Colitis

1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medical University Of Vienna Vienna Austria
Bispebjerg Hospital Copenhagen Denmark
Katholieke Universiteit te Leuven Leuven Belgium
General Hospital Venizeleio-Pananeio Heraklion Greece

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Azienda Sanitaria Locale Roma 2 Rome Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
University General Hospital Of Heraklion Heraklion Greece
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Pelican Impex S.R.L. Oradea Romania
Centrul Medical Medicum S.R.L. Bucharest Romania
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Evangelismos S.A. Athens Greece
Institutul Clinic Fundeni Bucharest Romania
Clinexpert Kft. Budapest Hungary
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Spitalul Clinic Colentina Bucuresti Bucharest Romania
University General Hospital Of Ioannina Ioannina Greece
Digestive Diseases Centre Gastro SIA Riga Latvia
Melita Medical sp. z o.o. Wroclaw Poland
Ospedale San Raffaele S.r.l. Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Centre Hospitalier Universitaire De Montpellier Montpellier France
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Gastro LM s.r.o. Presov Slovakia
University Of Szeged Szeged Hungary
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Second Multiprofile Hospital For Active Treatment – Sofia EAD Sofia Bulgaria
Uniklinikum Salzburg Salzburg Austria
Mind Klinika Kft. Budapest Hungary
Uvfqkyaquyiayltvgjcso Eqxsm Ajq Essen Germany
Lruxm Uxdnnmlmcxjk Mefwlde Cxryqvx (zhmsw Leiden The Netherlands
Hruhebzl Uzqxqryqcotir Df Lc Pfdfgows Madrid Spain
Ndiqfsndp Myuockuxgsc scitnb su Ktsxo Boafjeyencih v Pnslu Czechia
Paqoq Ieb Cmybrr Snirsw Neuilly-Sur-Seine France
Ohhu Tkekchlhnm Cfcnilg Gockhomehsgwuf Gwukphq Ovcy Tmpiabjmwh Poznan Poland
Ndrzrptqokip Zfshja Ofkcot Zdxkkqbgsc Txmnb Zmfgvox Eb Slo z otgm Elblag Poland
Laayn Gitwawk Hbhuqjlt Ou Abuhop Athens Greece
Pyocdabzdtt Embvijbrlxpo Wroclaw Poland
Hjnfsu Hzareexl Herlev Denmark
Hobhprps Uuwiztbmxn Cisajyy Hpeulfoy Helsinki Finland
Svb Ejlnlgjul Hcueflff Tyhiovt Tilburg The Netherlands
Cmum Dk Nkzbd Vandoeuvre Les Nancy France
Gdfcjk Ucnnuhagbi Fjfxrvtos Frankfurt Germany
Hguwzjdu Do Le Sgtep Cxnk I Srij Pii Barcelona Spain
Uawgjygijh Mrbaq Gmxeycd Or Cbsllesce Catanzaro Italy
Fvqgsqarh Plew Ls Ikehkatgwolyc Bnlvxrezm Dpq Hdqgxlra Uqdxrjmtapfwg Lm Pet Madrid Spain
Ioqxhoqq db Cacememtadlv Habhiydpusb Ummkudinoefyy dk Shcvf Eqtldin (zbpaoho Saint Priest En Jarez France
Uzplcungqj Ggdzwbx Hsmxkcjf Amzvcem Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
20.04.2022
Belgium Belgium
Not recruiting
20.04.2022
Bulgaria Bulgaria
Not recruiting
20.04.2022
Czechia Czechia
Not recruiting
20.04.2022
Denmark Denmark
Not recruiting
20.04.2022
Finland Finland
Not recruiting
20.04.2022
France France
Not recruiting
20.04.2022
Germany Germany
Not recruiting
20.04.2022
Greece Greece
Not recruiting
20.04.2022
Hungary Hungary
Not recruiting
20.04.2022
Italy Italy
Not recruiting
20.04.2022
Latvia Latvia
Not recruiting
20.04.2022
Poland Poland
Not recruiting
20.04.2022
Romania Romania
Not recruiting
20.04.2022
Slovakia Slovakia
Not recruiting
20.04.2022
Spain Spain
Not recruiting
20.04.2022
The Netherlands The Netherlands
Not recruiting
20.04.2022

Trial locations

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.

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 ID:
2023-506004-93-00
Protocol code:
20170104
NCT ID:
NCT04987307
Trial Phase:
Therapeutic exploratory (Phase II)

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