Study on the Long-Term Safety and Efficacy of Oral Ozanimod for Patients with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Ozanimod on individuals with Crohn’s Disease, which is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study aims to understand the long-term safety and effectiveness of Ozanimod for people who have moderate to severe forms of this disease. Ozanimod is taken orally in the form of a hard capsule.

Participants in the study will receive Ozanimod and will be monitored over a period to observe how their symptoms change. The study will look at various aspects, such as the reduction in abdominal pain and stool frequency, and improvements in the condition of the digestive tract. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ozanimod.

The study is designed to gather information over several years, providing insights into how Ozanimod can help manage Crohn’s Disease in the long term. Participants will be regularly assessed to track their progress and any changes in their condition. This research is important for developing better treatments for those living with Crohn’s Disease.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the long-term safety and effectiveness of ozanimod for treating moderately to severely active Crohn’s disease.

The patient will be required to provide written consent to participate in the study.

2 medication administration

The patient will receive ozanimod in the form of a hard capsule, taken orally.

The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.

3 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor the effectiveness and safety of the treatment.

These assessments may include measuring the Crohn’s Disease Activity Index (CDAI) score, which evaluates the severity of symptoms, and the Simple Endoscopic Score for Crohn’s Disease (SES-CD), which assesses the condition of the intestinal lining.

4 follow-up visits

The patient will attend scheduled follow-up visits to track progress and any changes in symptoms.

During these visits, the study team will collect data on the patient’s response to the treatment and any side effects experienced.

5 completion of the study

Upon completion of the study, the patient will have a final assessment to evaluate the overall impact of the treatment.

The study is estimated to conclude by March 24, 2031, at which point the patient will be informed of the study’s findings and any further recommendations.

Who Can Join the Study?

  • Patients must have moderately to severely active Crohn’s Disease. This means their condition is not mild and requires more intensive treatment.
  • Patients who did not respond or did not achieve remission after 12 weeks in specific previous studies, or those who experienced a relapse or completed certain studies, are eligible.
  • Patients must not have any restrictions according to local laws and must provide written consent before any study procedures begin.
  • Patients must be able to follow the study schedule and requirements.
  • Female patients of childbearing potential must agree to use a highly effective method of birth control during the study and until the 90-day follow-up visit. This includes methods like hormonal contraception, intrauterine devices, or complete abstinence.
  • Female patients must not have had a hysterectomy (removal of the uterus) or bilateral oophorectomy (removal of both ovaries), or must not have been postmenopausal for at least 24 months.
  • Both male and female patients are eligible to participate in the study.
  • The study includes patients from certain age groups, specifically those categorized as age range 3 and 4.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
PreventaMed s.r.o. Olomouc Czechia
Iscare a.s. Prague Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
San Camillo Forlanini Hospital Rome Italy
Santa Sp. z o.o. Lodz Poland
Hospital Beatriz Angelo Loures Portugal
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Eb Group Sp. z o.o. Warsaw Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Fondazione Poliambulanza Brescia Italy
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Medical Centre Synexus Sofia EOOD Sofia Bulgaria
Centrul De Diagnostic Si Tratament Provita S.A. Bucharest Romania
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Azienda Ospedaliera di Padova Padua Italy
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Clinfan Kft. Szekszard Hungary
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce Kielce Poland
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Semmelweis University Budapest Hungary
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Synexus Polska Sp. z o.o. Poznan Poland
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Poliklinika Solmed d.o.o. Zagreb Croatia
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Gastro LM s.r.o. Presov Slovakia
Beaumont Hospital Dublin Ireland
Universitaetsklinikum Leipzig AöR Leipzig Germany
UROMED Jakub Koteras Szczecin Poland
Gzbgb Bgoyjwg Knsdrmzzf Sjq z ogxy Klodzko Poland
Inebcvmpr Fqa Cmcqrfwb Aut Efieqypxzcdz Mkuwuwhy Prague Czechia
Hkvifxgk Ujkjbqwnsgunv Du La Pmxewutf Madrid Spain
Hirwolne Udacbgxfgurij Mogwzps Dx Vzidqxamlv Santander Spain
Cxweoxn Uzflg Mukocpvrpd Mdqpfb Bochnia Poland
Pkwjcofs Pptkfaud Lhpoqxpp lnem myki Mhfqgskd Fhf Jelenia Gora Poland
Pcowkpwr frh Gfweaqwrqvprgdrc aav Iypsufxd Msnxeysi Ludwigshafen Am Rhein Germany
Gtqzdjnhlpq svsavu Nove Zamky Slovakia
Suavmeelhalqsgv Pphcsrvk Lunpvcll dj mjxj Mlqxq Hrzcdssx Sopot Poland
Gpzgdijttgexpeqif Vxhhvvfmy Ptmc Ardwoe Exshsyht Otzecm Koiruu Gyor Hungary
Gwaqdy Ukjmvakius Fvsilxobc Frankfurt Germany
Mafakobiflldipfygknrnsxkrz Hublwhkhawgckaxs Halle (Saale) Germany
Fubhitbyo Pnbl Lg Iopwivitbyoum Biethaqdb Doc Hyqdzlpi Urlnexvckwizu Lr Pgm Madrid Spain
Ibgblsmo de Cvyytjushjah Hwwrtemgxto Uowktwpmrvqtf ds Sfbdr Ehpwmbn (awvijos Saint Priest En Jarez France
Whg Wzifxu Inw Ploiv Ppujbuib Kccrkoo Warsaw Poland
Mvbzofkw Svk z ojxp Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
14.11.2018
Croatia Croatia
Not recruiting
14.11.2018
Czechia Czechia
Not recruiting
14.11.2018
France France
Not recruiting
14.11.2018
Germany Germany
Not recruiting
14.11.2018
Hungary Hungary
Not recruiting
14.11.2018
Ireland Ireland
Not recruiting
14.11.2018
Italy Italy
Not recruiting
14.11.2018
Latvia Latvia
Not recruiting
14.11.2018
Poland Poland
Not recruiting
14.11.2018
Portugal Portugal
Not recruiting
14.11.2018
Romania Romania
Not recruiting
14.11.2018
Slovakia Slovakia
Not recruiting
14.11.2018
Spain Spain
Not recruiting
14.11.2018
The Netherlands The Netherlands
Not recruiting
14.11.2018

Trial locations

Investigated drugs:

Ozanimod is a medication being studied for its potential to treat moderately to severely active Crohn’s Disease. It is taken orally and is part of a long-term study to assess its safety and effectiveness in managing the symptoms of this condition.

Investigated diseases:

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can vary in severity, with some people experiencing mild symptoms and others having more severe manifestations. Over time, the inflammation can cause damage to the digestive tract, affecting its ability to function properly.

Trial ID:
2024-511553-22-00
Protocol code:
RPC01-3204
Trial Phase:
Therapeutic confirmatory (Phase III)

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