Continued study of ozanimod for severe Crohn’s Disease

Recruting new patients

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    What is this study about?

    This research is about an extended study on the use of an oral medication named Ozanimod for people suffering from Crohn’s disease. Crohn’s disease can make the stomach and intestines really uncomfortable, causing swellings and pain. The main aim of this study is to check if this medicine, Ozanimod, is safe for intake and how effective it is in easing these uncomfortable feelings in the stomach. The researchers will rate patients’ illnesses using the Crohn’s Disease Activity Index (a measurement tool).

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Leuven , Belgium

      Liege , Belgium

      Blagoevgrad , Bulgaria

      Ruse , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Brno , Czechia

      Brno , Czechia

      Hradec Kru00e1lovu00e9 , Czechia

      Olomouc , Czechia

      Pardubice , Czechia

      Prague , Czechia

      Praha 4 , Czechia

      Amiens cedex 1 , France

      Caen , France

      Creteil Cedex , France

      Dijon Cedex , France

      Nantes , France

      Neuilly-sur-Seine , France

      Pierre-Benite , France

      Rouen Cedex , France

      Saint Priest en Jarez , France

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Dachau , Germany

      Frankfurt am Main , Germany

      Frankfurt am Main , Germany

      Frankfurt , Germany

      Halle , Germany

      Halle , Germany

      Keil , Germany

      Leipzig , Germany

      Leipzig , Germany

      Ludwigshafen am Rhein , Germany

      Muenster , Germany

      Tuebingen , Germany

      Ulm , Germany

      Bekescsaba , Hungary

      Budapest , Hungary

      Gyor , Hungary

      Szekesfehervar , Hungary

      Szekszu00e1rd , Hungary

      Brescia , Italy

      Brescia , Italy

      Castellana Grotte , Italy

      Chieti , Italy

      Milano , Italy

      Milan , Italy

      Monza , Italy

      Padova , Italy

      Pavia , Italy

      Roma , Italy

      Rome , Italy

      Udine , Italy

      Amsterdam , Netherlands

      Groningen , Netherlands

      Nijmegen , Netherlands

      Sittard-Geleen , Netherlands

      Tilburg , Netherlands

      Zamosc , Poland

      Gdansk , Poland

      Gdynia , Poland

      Jelenia Gora , Poland

      Katowice , Poland

      Katowice , Poland

      Katowice , Poland

      Klodzko , Poland

      Krakow , Poland

      Krakow , Poland

      Ksawerow , Poland

      Lodz , Poland

      Lublin , Poland

      Nowy Targ , Poland

      Olsztyn , Poland

      Opole , Poland

      Oswiecim , Poland

      Poznan , Poland

      Poznan , Poland

      Sopot , Poland

      Sopot , Poland

      Szczecin , Poland

      Szczecin , Poland

      Tychy , Poland

      Ul. Piotrkowska 177 , Poland

      Warsaw , Poland

      Warsaw , Poland

      Warsaw , Poland

      Warszawa , Poland

      Wroclaw , Poland

      Wroclaw , Poland

      Wroclaw , Poland

      Loures , Portugal

      Viana do Castelo , Portugal

      Bucharest , Romania

      Bucharest , Romania

      Bucharest , Romania

      Napoca , Romania

      Bratislava , Slovakia

      Nove Zamky , Slovakia

      Presov , Slovakia

      Rimavska Sobota , Slovakia

      Alicante , Spain

      Girona , Spain

      La Laguna , Spain

      Madrid , Spain

      Madrid , Spain

      Santander , Spain

      Birmingham , United Kingdom

      Cardiff , United Kingdom

      Chorley , United Kingdom

      Corbridge Road , United Kingdom

      London , United Kingdom

      London , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In the clinical trial, patients will be taking a specified dose on specified days. The trial involves the administration of the oral drug Ozanimod. However, the exact dosage and schedule details haven’t been provided in the quoted section.

      For more detailed information on the dosage and the schedule, you may need to contact the central point of contact for the trial at Clinical.Trials@bms.com. They can provide you with the specific information regarding the dosage and frequency of administration that pertains to your participation in the trial.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, the relevant disease you need to have is Crohn’s Disease. More specifically, the inclusion criteria related to diseases are as follows:

      1. Not in clinical response or clinical remission after completing 12 weeks in the Induction Studies.
      2. Experience relapse or who complete the Maintenance Study.
      3. Complete a study of ozanimod for Crohn’s Disease and meet the criteria for participation.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is the list of conditions you must meet to join the study:

      1. Not in clinical response or clinical remission: After completing 12 weeks in the Induction Studies of the clinical trial for Crohn’s Disease, you must not be in clinical response or remission. Clinical response typically refers to a significant decrease in symptoms, whereas clinical remission means an absence of symptoms.
      2. Experience relapse or complete the Maintenance Study: You must have either experienced a relapse of symptoms after initial improvement or have completed the Maintenance Study phase of the clinical trial. A relapse means the return of disease symptoms after a period of improvement.
      3. Completion of a study of ozanimod for Crohn’s Disease: You must have completed a previous study of ozanimod, which is the drug being tested, specific to Crohn’s Disease treatment, and meet the criteria for participation in the current study.

      Please note that specific medical terminology such as “clinical response” and “clinical remission” refer to the measured improvement or the complete resolution of the condition being treated, which in this case is Crohn’s Disease.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude someone from participating in the study, along with explanations of the medical terms:

      1. Clinically relevant hepatic disease
      2. : This means having a liver disease that affects one’s health in a significant way and could interfere with the study or increase the risk to the participant.

      3. Neurological disease
      4. : Refers to disorders of the nervous system which might affect the implementation of the protocol or interpretation of the study results.

      5. Pulmonary disease
      6. : Lung-related illnesses that could impact the study or pose a risk to the participant.

      7. Ophthalmological disease
      8. : Eye conditions that could make it difficult to conduct the study or that could endanger the participant.

      9. Endocrine disease
      10. : Disorders of the glands that produce hormones, which could interfere with the study or the participant’s safety.

      11. Psychiatric disease
      12. : Mental health conditions that might affect how the study is carried out or how results are understood.

      13. Other major systemic disease
      14. : Any other significant illness involving the body’s systems that could complicate the study or pose a risk to the participant.

      15. Intra-abdominal or perianal abscess
      16. : These are collections of pus that have formed inside the abdominal cavity or around the anus that have not been treated properly.

      17. Treatment with CYP2C8 inducers
      18. : These are drugs that increase the activity of an enzyme in the liver, which could affect how other medications are processed in the body.

      19. Monoamine oxidase inhibitors
      20. : A class of drugs typically used to treat depression that could interact with the study medication or protocol.

      Please note that other criteria not listed here might also apply, as there are additional protocol-defined inclusion/exclusion conditions.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is Ozanimod. Here is a brief description of the active substance:

      1. Ozanimod: This is an oral medication that acts as a sphingosine 1-phosphate receptor modulator, which is used to influence the immune system and reduce inflammation.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial is studying the administration of oral Ozanimod in participants who have moderately to severely active Crohn’s Disease. Below is a list of the active substances and details about Ozanimod:

      1. Ozanimod: This is the active substance used in the trial for the treatment of Crohn’s Disease. Ozanimod is known to medicine and the medical literature, is currently being researched for its potential use in treating various conditions and is being administered orally in specified doses on specified days.

      Study ID

      CT-EU-00053616

      Recruitment status

      Recruting new patients

      Start of the trial

      6 years ago

      Study phase

      Phase
      III

      Medicinal Product