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.
1Initial 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
2Medication 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)
3Treatment 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
4Evaluation 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
F D Roosevelt University General Hospital Of Banska Bystrica
Banska Bystrica
Slovakia
Evangelismos S.A.
Athens
Greece
University General Hospital Of Ioannina
Ioannina
Greece
Ospedale San Raffaele S.r.l.
Milan
Italy
Universitair Medisch Centrum Utrecht
Utrecht
The Netherlands
Centre Hospitalier Universitaire De Montpellier
Montpellier
France
General University Hospital Of Patras
Patras
Greece
Centre Hospitalier Universitaire De Nice
Nice
France
University General Hospital Of Alexandroupoli
Alexandroupoli
Greece
University Of Szeged
Szeged
Hungary
Centre Hospitalier Universitaire Amiens Picardie
Amiens
France
Centre hospitalier universitaire de Liege
Liege
Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm
Germany
Universitaetsklinikum Schleswig-Holstein AöR
Kiel
Germany
Hospital General Universitario Gregorio Maranon
Madrid
Spain
Universita Degli Studi Di Brescia
Brescia
Italy
University General Hospital Of Heraklion
Heraklion
Greece
Centrum Medyczne Med-Gastr Sp. z o.o.
Lodz
Poland
Uniklinikum Salzburg
Salzburg
Austria
Fundeni Clinical Institute
Bucharest
Romania
Endomed s.r.o.
Kosice
Slovakia
Pauls Stradins Clinical University Hospital
Riga
Latvia
Diagnostics And Consultation Center Convex Ltd.
Sofia
Bulgaria
Clinexpert Kft.
Budapest
Hungary
Bodyclinic Sp. z o.o. sp.k.
Warsaw
Poland
Spitalul Clinic Colentina Bucuresti
Bucharest
Romania
Azienda Sanitaria Locale Roma 2
Rome
Italy
Obudai Egeszseguegyi Centrum Kft.
Dunaújváros
Hungary
Digestive Diseases Centre Gastro SIA
Riga
Latvia
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar di Valpolicella
Italy
Second Multiprofile Hospital For Active Treatment – Sofia EAD
Sofia
Bulgaria
Melita Medical sp. z o.o.
Wroclaw
Poland
Pratia S.A.
Skorzewo
Poland
Hepato-Gastroenterologie HK s.r.o.
Hradec Kralove
Czechia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Bucharest
Romania
Spitalul De Oncologie Monza S.R.L.
Bucharest
Romania
Bekes Varmegyei Koezponti Korhaz
Gyula
Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabanya
Hungary
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Malbork
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
Gastro LM s.r.o.
Presov
Slovakia
Mind Klinika Kft.
Budapest
Hungary
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Athens
Greece
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Denmark
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Helsinki
Finland
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France
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Spain
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Germany
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Madrid
Spain
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Madrid
Spain
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Athens
Greece
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Elblag
Poland
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France
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France
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Wroclaw
Poland
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Poznan
Poland
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Tilburg
The Netherlands
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Frankfurt
Germany
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The Netherlands
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Italy
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not recruiting
20.04.2022
Belgium
Not recruiting
20.04.2022
Bulgaria
Not recruiting
20.04.2022
Czechia
Not recruiting
20.04.2022
Denmark
Not recruiting
20.04.2022
Finland
Not recruiting
20.04.2022
France
Not recruiting
20.04.2022
Germany
Not recruiting
20.04.2022
Greece
Not recruiting
20.04.2022
Hungary
Not recruiting
20.04.2022
Italy
Not recruiting
20.04.2022
Latvia
Not recruiting
20.04.2022
Poland
Not recruiting
20.04.2022
Romania
Not recruiting
20.04.2022
Slovakia
Not recruiting
20.04.2022
Spain
Not recruiting
20.04.2022
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.
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