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
Innomedica OÜ	Tallin	Estonia
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
University Hospital Ostrava	Ostrava	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Fakultni Nemocnice Bulovka	Prague	Czechia
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Allmedica Badania Kliniczne Sp. z o.o.	Nowy Targ	Poland
Dermastyle S.R.L.	Bucharest	Romania
Semmelweis University	Budapest	Hungary
Uvgqgensnt Mvawoobeijgy Hpkvqsgp Fkw Arceby Txzoqvheb Ayc Eoivtkztb Maxihbot N I Pjytftg	Sofia	Bulgaria
Dmypgfjtqonwpxmphqjwtxl chnadw “sjmvfgatiizqhod Eqev	Sofia	Bulgaria
Ndgko Exqwyld Mqzcaev Ctpyuv Fppbjapukx	Tallin	Estonia
Voesypje upzkiowfonml lnculovz Sqaoliad kkblztgb Vzm	Vilnius	Lithuania
Csqscf Hznvswuwjz E Uhbdbwvcigkjd Dl Clfymak Eoqtby	Coimbra	Portugal
Iqutjkfb Uzk	Kaunas	Lithuania
Afehyoee Zjkhuzahyy Dafff	Roeselare	Belgium
Dtqlx Hslwes Csya Sywcxd	Bucharest	Romania
Fvizh Vaucbdvhy Sfptd Garckxh Emngnrta Oamhwf Kjujde	Szekesfehervar	Hungary
Ddrelwvczus Agt Cjksqjqgwrot Ctgjpf Cmceea Lxmk	Sofia	Bulgaria
Cfwtzhd Kiuy	Szekszard	Hungary
Ahtubpl Sumrqqods Lqtrpo Rpdk 2	Rome	Italy
Polzshus givzwlzzepzchrmtfxc amxktpoxv swdqdbd Mqpvg Zcmtvn Vxn	Prostejov	Czechia
Nifhd Tljzlzdet – Cwbrxkc Bktew Kuwmdjtavdu	Poznan	Poland
Cjrvyzf Zsbkysb Mwd	Warsaw	Poland
Merujfdpkfcihdpjdxpbishzwerc	Remscheid	Germany
Apbidfs Ssp z oxbs Sudu	Lodz	Poland
Alrnnks Oezitaihrtu Pna Lkyouohtsatudmdyz Cwkcacwxry	Catania	Italy
Hfxsubtxzointjwcqlgfqnaq Hb shilsh	Hradec Kralove	Czechia
Lfspmfgzjqokxb Krhhmarqln Ax	Pohja-Tallinna Linnaosa	Estonia
Cvfzoqn Mriagosf Mfvpx Sai z onci	Rzeszow	Poland
Uefhdzoufr Mqrzd Gnfzqzr Of Cshkfrqsz	Catanzaro	Italy
Kngyyrgkjrx Wlfvtbqvzq eifb	Berlin	Germany
Tjzab Phoeiydoprc Siwclciiociu Ccnheca Mfejmlje Sox z oawl	Szczecin	Poland
Dauyfq Mbgzwt Kiemfzsk suhek	Swidnica	Poland
Kntgipvmmhtct Nlwpv stciqx	Nitra	Slovakia
Nkkvfrvx Iryjngrgp Ol Ghsbjcebnamktzle Sigznzo Dq Byxtfs Rxsialer Hbncwnqu	Castellana Grotte	Italy
Aedxg sfnizd	Bardejov	Slovakia
Cftwshl Mpyrvrns Owsxew	Wroclaw	Poland
Iy Cqvpat Sux z offf	Lodz	Poland
Dfd Knwd	Balatonfured	Hungary
Ufmzomreqx Mevcsfrhjcvwkepbr Hqtfyoot Fqb Adivtq Tehzbxkai Kwvlm At	Ruse	Bulgaria
Mrnkzrt Ciqxgb Masyvq Pdgd Ledj	Veliko Tirnovo	Bulgaria
Ramxlldannuc Pgknvjbwl lhkcdhkd Vjx	Panevezys	Lithuania
Gnvqsm Jhwz sfwjav	Klatovy	Czechia
Aaehovi Svnqa Seowaxzar Tipjjrrnyqxz Rnknffvu	Rho	Italy
Mrkvprna Smi z orju	Oświęcim	Poland
Pwglldtn Mrpvrqkaqhb Cwuskvb Kbgd	Budapest	Hungary
Krjtlsk Crlque Moiuprqgny Jzhnxd Siuhsnufohwjota Puxylkpo Gcbflgosiitezfrwettqhwgko	Sosnowiec	Poland
Bzntp Vypkjycvq Kdqzaciba Kpmvbt	Bekescsaba	Hungary
Cgjnsz Hxbzrzlfarc Uzyvwfcayjdtw Dh Nzhc	Nice	France
Egu Iekzcitr Mhoiotki Sdhh	Wroclaw	Poland

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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