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

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What is this study about?

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.

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 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 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

4 104-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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
General Hospital Venizeleio-Pananeio	Heraklion	Greece

Other Sites

Site Name	City	Country
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
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
Lmxah Gidraca Hmgassir Ob Adzjls	Athens	Greece
Hjzhrb Hetkpxze	Herlev	Denmark
Hzavzred Ujrkuncanv Chgaldq Hnxqpkyt	Helsinki	Finland
Ckwm Dx Nwjlj	Vandoeuvre Les Nancy	France
Hnlrjgnz Dl Lj Sjzho Cbpg I Sdxf Pqy	Barcelona	Spain
Ucwfsefmpgavonmncvvbc Edtgq Ann	Essen	Germany
Hagwixba Udscsvfoncgyj Di Li Ppfqrqle	Madrid	Spain
Udxanyirex Gxzevho Hmfstqly Ahkreut	Athens	Greece
Nbmozbvmbkop Zzhokm Oxoygl Zhddrnyvjb Tddko Zpkwsll Ef Sdz z obpl	Elblag	Poland
Pzoih Imx Cuyzzp Szeqqj	Neuilly-Sur-Seine	France
Iifmphwl dk Cjgsbnlrgncd Hnjedpffian Uowqakyyhsqyq ds Sggya Enxodmv (kwyykpj	Saint Priest En Jarez	France
Pvisjvejwey Ezsgxqcsiguu	Wroclaw	Poland
Okdg Tpeoqpkcag Cabwqxh Gxpyzoknviixkd Gfggafd Ogeb Tpfyddkfhx	Poznan	Poland
Sgs Ehypownyl Hhodeyyt Ttbzjmw	Tilburg	The Netherlands
Gparhj Uxfwisriij Fjxmwsspb	Frankfurt	Germany
Lzaii Uugzyvdtaywr Mttbqqm Cxztrxt (lmicm	Leiden	The Netherlands
Ujqvcuomlg Mfzhn Gyxbvpf Oe Cucnuxwry	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	27.10.2023
Belgium	Not recruiting	27.10.2023
Bulgaria	Not recruiting	27.10.2023
Czechia	Not recruiting	27.10.2023
Denmark	Not recruiting	27.10.2023
Finland	Not recruiting	27.10.2023
France	Not recruiting	27.10.2023
Germany	Not recruiting	27.10.2023
Greece	Not recruiting	27.10.2023
Hungary	Not recruiting	27.10.2023
Italy	Not recruiting	27.10.2023
Latvia	Not recruiting	27.10.2023
Poland	Not recruiting	27.10.2023
Romania	Not recruiting	27.10.2023
Slovakia	Not recruiting	27.10.2023
Spain	Not recruiting	27.10.2023
The Netherlands	Not recruiting	27.10.2023

Trial locations

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.

Investigated Diseases:

Colitis ulcerative

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 ID:

2023-506046-24-00

Protocol code:

20210210

NCT ID:

NCT05672199

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?