Study on Long-Term Safety of Etrasimod Arginine for Patients with Moderately to Severely Active Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Etrasimod Arginine in individuals with Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The medication is provided in tablet form and is taken orally. The main goal of the study is to assess the safety of using Etrasimod Arginine over a long period in people who have moderate to severe symptoms of Ulcerative Colitis.

Participants in the study will receive Etrasimod Arginine and will be monitored for any side effects or changes in their health. The study will track the occurrence of any new health issues that arise during the treatment, as well as any changes in laboratory test results and vital signs. The study will also look at how many participants experience an improvement in their symptoms over time.

The study will continue for several years, allowing researchers to gather comprehensive data on the long-term use of Etrasimod Arginine. Participants will have regular check-ups to monitor their condition and the effects of the medication. This research aims to provide valuable information on the safety and effectiveness of Etrasimod Arginine for treating Ulcerative Colitis.

1 joining the study

Upon joining the study, the patient will begin participation in an open-label extension study designed to assess the safety of long-term administration of etrasimod for those with moderately to severely active ulcerative colitis.

The study involves taking etrasimod arginine in the form of a tablet, administered orally.

2 medication administration

The patient will take the etrasimod arginine tablet as prescribed by the study protocol. The specific dosage and frequency will be determined by the study guidelines and the healthcare provider overseeing the trial.

3 monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the incidence of any treatment-emergent adverse events and serious adverse events.

Laboratory tests will be conducted to monitor any changes in blood and urine samples, as well as vital signs, to ensure the patient’s safety.

4 evaluation of treatment effectiveness

The effectiveness of the treatment will be evaluated by measuring the proportion of patients achieving clinical remission and response at various intervals, specifically at Weeks 52 and 104.

Changes from baseline in the Total Mayo Score and Partial Mayo Score will be assessed at specified weeks to determine the impact of the treatment on ulcerative colitis symptoms.

5 endoscopic improvement

Endoscopic evaluations will be conducted to assess improvements in the condition of the colon lining at Weeks 52 and 104.

6 completion of the study

The study is estimated to conclude by June 19, 2029. The patient will continue to be monitored and assessed until the end of the study period.

Who Can Join the Study?

You must have been part of certain previous studies related to ulcerative colitis and meet specific conditions. For example, you should have completed certain visits in those studies or have a specific score from a test called an endoscopy.
If you are a woman who can have children, you need to have a negative pregnancy test and not be breastfeeding at the start of the study.
Women who can have children must agree to use a very effective birth control method during the study and for 30 days after. This can include certain hormonal methods, an intrauterine device (IUD), or other reliable methods. Men must agree to use condoms if their partner can have children.
You must be able to give written consent to participate in the study. If you are under 18, a parent or guardian must give consent, and you must agree to follow the study’s schedule. Participation of those under 18 is allowed only if it is acceptable by local laws.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who have had recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions to medications.
Patients with certain infections that are not well controlled.
Patients who have used certain medications that might affect the study results.
Patients with a history of drug or alcohol abuse.
Patients who have been diagnosed with cancer in the past five years, except for some types of skin cancer.
Patients with certain heart conditions that are not well controlled.
Patients with liver or kidney problems that are not well controlled.
Patients who have had a blood transfusion in the past three months.
Patients with a history of certain autoimmune diseases, which are conditions where the body’s immune system attacks its own tissues.
Patients who have been vaccinated with certain live vaccines in the past four weeks.
Patients who have a history of tuberculosis, a serious lung infection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Innomedica OÜ	Tallin	Estonia

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Azienda Sanitaria Locale Roma 2	Rome	Italy
Amicare Sp. z o.o. S.K.	Lodz	Poland
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Krankenhaus Waldfriede e.V.	Berlin	Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Delta Health Care S.R.L.	Bucharest	Romania
Fakultni Nemocnice Bulovka	Prague	Czechia
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
National Institute Of Gastroenterology Saverio De Bellis Research Hospital	Castellana Grotte	Italy
Alian s.r.o.	Bardejov	Slovakia
Centrum Medyczne Oporow	Wroclaw	Poland
Ip Clinic Sp. z o.o.	Lodz	Poland
DRC Kft.	Balatonfured	Hungary
University Multiprofessional Hospital For Active Treatment Kanev AD	Ruse	Bulgaria
Medical Center Medica Plus Ltd.	Veliko Tirnovo	Bulgaria
Respublikine Panevezio ligonine VšĮ	Panevezys	Lithuania
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Clinfan Kft.	Szekszard	Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Ospedale San Raffaele S.r.l.	Milan	Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Semmelweis University	Budapest	Hungary
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Laane-Tallinna Keskhaigla AS	Pohja-Tallinna Linnaosa	Estonia
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Dc-Med Michal Kowalski sp.k.	Swidnica	Poland
Kardiocentrum Nitra s.r.o.	Nitra	Slovakia
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Centrum Zdrowia MDM	Warsaw	Poland
North Estonia Medical Centre Foundation	Tallin	Estonia
University Hospital Ostrava	Ostrava	Czechia
Allmedica Badania Kliniczne Sp. z o.o.	Nowy Targ	Poland
Gastro Jeka s.r.o.	Klatovy	Czechia
Pannonia Maganorvosi Centrum Kft.	Budapest	Hungary
EMC Instytut Medyczny S.A.	Poznan	Poland
Spitalul de Oncologie Monza	Bucharest	Romania
Kiepury Clinic Małgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno-Położnicza	Sosnowiec	Poland
Pxjepocb gbcuikhvfvrurfgnkxw athgiztgi spzxzde Mcsca Zefxsd Vcx	Prostejov	Czechia
Noncv Togqxwaap – Cwpmrgn Bchcm Krhzkqskyau	Poznan	Poland
Utsvoamhyd Mhumi Gcgnues Ok Cjmxnjwvw	Catanzaro	Italy
Mrabhvhrrqrhldbkyprqryofwfhc	Remscheid	Germany
Acdadmj Orwjvsonurp Pht Lvlriypqsannkfcrt Cdklzzlzqd	Catania	Italy
Ijrvingk Uhc	Kaunas	Lithuania
Auvhcyg Svcxy Scravrfbk Ttftbulodkdi Rjzbrtzb	Rho	Italy
Mfgpitrs Suk z obuj	Oświęcim	Poland
Cerneu Hxqazczwfo E Urmthgomqgndf Dx Cnlosth Eqogsl	Coimbra	Portugal

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	09.03.2020
Bulgaria	Not recruiting	09.03.2020
Czechia	Not recruiting	09.03.2020
Estonia	Not recruiting	09.03.2020
France	Not recruiting	09.03.2020
Germany	Not recruiting	09.03.2020
Hungary	Not recruiting	09.03.2020
Italy	Not recruiting	09.03.2020
Lithuania	Not recruiting	09.03.2020
Poland	Not recruiting	09.03.2020
Portugal	Not recruiting	09.03.2020
Romania	Not recruiting	09.03.2020
Slovakia	Not recruiting	09.03.2020
Spain	Not recruiting	09.03.2020

Trial locations

Investigated drugs:

Etrasimod Arginine

Etrasimod is a medication being studied for its safety in long-term use for people with moderately to severely active ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the digestive tract. Etrasimod works by modulating the immune system to reduce inflammation, which may help manage the symptoms of ulcerative colitis. This study is an open-label extension, meaning all participants receive etrasimod, and the focus is on monitoring its safety over an extended period.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.

Trial ID:

2024-515156-21-00

Protocol code:

C5041012(APD334-303)

NCT ID:

NCT03950232

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Term Safety of Etrasimod Arginine for Patients with Moderately to Severely Active Ulcerative Colitis

What is this study about?

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