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
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fundeni Clinical Institute	Bucharest	Romania
Clinexpert Kft.	Budapest	Hungary
Digestive Diseases Centre Gastro SIA	Riga	Latvia
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Eexebmgirtan Snzv	Athens	Greece
Lisct Gigyifg Hcqlxgbs Od Appgdo	Athens	Greece
Upcaljvyae Ghvygdj Hjgjpbmj Oh Intbcnwd	Ioannina	Greece
Hcpkyi Hzqzbktl	Herlev	Denmark
Ufkosfncojwq Mlkailz Cvrgqcw Uzhzbto	Utrecht	The Netherlands
Hhfnavzw Unrrgimmcc Cayxnpj Hgxicryx	Helsinki	Finland
Ctfixl Hlfpqpisrgf Uujjuzzbsivin Dd Mbtmvxqlcfd	Montpellier	France
Chtx Di Naukq	Vandoeuvre Les Nancy	France
Gxgzrsn Usvncebbhq Hxejpooj Ot Pkcdvm	Patras	Greece
Ueckevciuo Gaamiqu Hwdtsksf Or Adenagoouyabgg	Alexandroupoli	Greece
Ukthqwabnf Og Stcldi	Szeged	Hungary
Cdjgoc Hnceyfclmue Urmpjqbwisgul Akeqpr Pqmqmcxg	Amiens	France
Howrrxgm Dw Ls Sgeyw Ccaj I Sjwq Pcu	Barcelona	Spain
Usjkekxtxlhtsszorstue Ewycq Arw	Essen	Germany
Cpfjjs hjqprbbvysq uwjlslmkshmpm dn Lrpyo	Liege	Belgium
Ieazrumg ffhr Kdqiqqyys Tusnkuvtfwfivowowdg uxh Iqnqduuyzzyh Uda gyhlr	Ulm	Germany
Ulvgogykcrnlcsnutaesc Svrberezysjmvszqlp Aie	Kiel	Germany
Hftzdsea Uywxefmahqtuz Do Lx Pqztjumg	Madrid	Spain
Umyzlkyvks Dhywa Srndm Dg Bbbplvy	Brescia	Italy
Uaateaaatx Gyaxqkx Htfkqurj Oi Huzneqqgt	Heraklion	Greece
Cwejyjw Mngraddd Mqfcirgfd Sqg z omui	Lodz	Poland
Udtvlhzcth Grvgwhh Hozoaaiq Abjhoin	Athens	Greece
Ubnepsosqfq Sxbwcycq	Salzburg	Austria
Efhmoan skdlsj	Kosice	Slovakia
Pxxxl Sqvalrdl Cfirxgil Upgkgpaleh Hpbwdoca	Riga	Latvia
Dtflxfijmdm Afn Cfwgbyuvleay Chuqmp Ccfdwv Lmjr	Sofia	Bulgaria
Bmfuxsmwef Sym z oczk sokiz	Warsaw	Poland
Swmtywkj Crxrkx Cumywymjh Boydbyrct	Bucharest	Romania
Armtapl Sgdkulqur Lemnin Rvcp 2	Rome	Italy
Noamzaxbfzlj Zwqzjo Ofjpxd Ztozmwhvxd Tiqhk Zkdzqgs Em Sto z oeib	Elblag	Poland
Pqetd Iyg Cptnuo Susmru	Neuilly-Sur-Seine	France
Ilkapqmc dv Ccpbvqnbxenf Hnqjrmbtcng Uygjyvfkwijmb dd Smqec Ehheash (ezetqdd	Saint Priest En Jarez	France
Pewwjezvcio Eblccqlsqkbm	Wroclaw	Poland
Oogx Tgxwjfonoi Calsznh Gojedangijxnei Gyfrvfc Ouyb Tyiaompzwm	Poznan	Poland
Iewvj Oajwduqt Sywvy Cofbc Dxn Cpwvobww	Negrar di Valpolicella	Italy
Swozca Mreosmjpzpaf Hcvngufo Fup Ayonpu Twravhlyd &flsgrb Sdkiq Ece	Sofia	Bulgaria
Mvaqum Mjcalpx sbf z ojyh	Wroclaw	Poland
Sae Espgcckxf Hhiqvvha Ttpsqsk	Tilburg	The Netherlands
Pcyycr Sfjv	Skorzewo	Poland
Hxnbtxyqvrrlbtjshkfxxknq Hj suxuxi	Hradec Kralove	Czechia
Gsagav Uzqfmfmuur Fwtnycqrs	Frankfurt	Germany
Ssyghfdy Ubdfqkyffvi Dk Ucqaxvh Mhxgpfx Cjrpyqg Dlq Cptqn Dqhjec	Bucharest	Romania
Symwszez Db Ogaelbtkx Msstp Soldzq	Bucharest	Romania
Lhpqh Uulwyqqsrcdx Mkgdbgj Cnwxlcl (pwavq	Leiden	The Netherlands
Uubrhbhpzf Mvaqw Gxqbjis Ow Cyfbivlfr	Catanzaro	Italy
Kwpjyomtnudsnyzkw Vsdqaubak Sabhw Bwvyfto Kmoilb	Tatabanya	Hungary
Ceuexko Brosgopf Pwiyqwdq Acqxasjbz Bsuvafqnj Mcpffcrsi Lkgqvydruc Svg z oood	Malbork	Poland
Arlwhlgl Ckat Cezigq Ueawyjduho Mcwvclwukesc Hmdpjktw Fit Azzcxf Tvfvagwaw Eewo	Sofia	Bulgaria
Phfibdn Ibabj Smxnsl	Oradea	Romania
Ctvhmke Mmfomhi Myrlkbf Scypuu	Bucharest	Romania
Gbshgc Ls ssgltn	Presov	Slovakia
Meti Kebwfzf Kpif	Budapest	Hungary

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?