Study of Oral Ozanimod as Maintenance Treatment for Adults with Moderate to Severe Crohn’s Disease

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What is this study about?

This study focuses on Crohn’s Disease, specifically its moderate to severe form, which is a long-term condition causing inflammation of the digestive system. The study examines ozanimod, a medication taken by mouth in the form of capsules, to determine if it can help maintain improvement in patients who have already shown positive response to initial treatment.

The research aims to show how well ozanimod works compared to placebo in maintaining disease remission (a state where symptoms are minimal or absent) and improving the appearance of the intestinal lining when viewed through medical examination. The medication will be given as hard capsules that patients take by mouth. Some participants will receive ozanimod while others will receive placebo capsules that look identical to the real medication.

During the study, participants will be monitored for about one year to assess how well the treatment maintains control of their disease symptoms. The study will track various aspects of the disease, including stomach pain, bowel movements, and the condition of the intestinal lining. The maximum daily dose of ozanimod used in the study is 0.92 mg.

1 Initial assessment

After completing the 12-week induction study, your eligibility for the maintenance study will be evaluated based on your response to previous treatment.

You must show a reduction in Crohn’s Disease Activity Index (CDAI) of at least 100 points or have a score below 150 points.

Alternatively, you may qualify if you have an average daily stool frequency score of 3 or less and average abdominal pain score of 1 or less, with neither symptom worse than when you started treatment.

2 Treatment assignment

You will be randomly assigned to receive either ozanimod capsules or placebo capsules (capsules without active medication).

The capsules are to be taken by mouth.

Neither you nor your doctor will know which treatment you are receiving.

3 52-week treatment period

You will take the assigned medication for 52 weeks.

Regular assessments will monitor your CDAI score, abdominal pain, and stool frequency.

An examination of your intestines (endoscopy) will be performed to assess healing.

If you are taking corticosteroids, their use will be monitored during the last 12 weeks of the study.

4 Safety monitoring

Your health will be monitored throughout the study period.

Female participants must use effective birth control methods throughout the study and for 90 days after the last dose.

The study will track any worsening of symptoms, including an increase in CDAI score of 100 points or more above starting value and a score greater than 220.

5 Final evaluation

At week 52, final assessments will be conducted to evaluate the effectiveness of the treatment.

These include measuring your CDAI score, examining your intestines, and evaluating tissue samples if taken.

The study will assess whether you achieved remission (improvement) of your Crohn’s disease symptoms.

Who Can Join the Study?

  • Must have completed the 12-week initial treatment phase (Induction Study) and all required assessments at Week 12
  • Must be able to provide written informed consent and follow all study procedures and visits
  • Must have achieved one of the following responses after 12 weeks of initial treatment:
    • A reduction in CDAI (Crohn’s Disease Activity Index) score of at least 100 points
    • A CDAI score less than 150 points
    • An average daily stool frequency of 3 or fewer times per day
    • An average abdominal pain score of 1 or less (on a defined scale)
  • Women who can become pregnant must agree to use one of these effective birth control methods throughout the study and for 90 days after:
    • Combined hormonal contraception (pills, vaginal ring, or patch)
    • Progestogen-only contraception (pills, injection, or implant)
    • Intrauterine device (IUD)
    • Intrauterine hormone system (IUS)
    • Tubal ligation
    • Partner with vasectomy
    • Complete sexual abstinence
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • Current treatment with medications that suppress the immune system (such as cyclosporine, tacrolimus, or similar drugs)
  • History of severe allergic reactions to any medications
  • Active or untreated tuberculosis infection
  • Presence of serious heart conditions or irregular heart rhythm
  • Severe liver disease or abnormal liver function tests
  • Current or recent cancer diagnosis within the past 5 years
  • Active serious infections requiring treatment
  • History of certain neurological conditions like multiple sclerosis
  • Pregnancy or breastfeeding
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Recent major surgery within the past 3 months
  • Current participation in other clinical trials
  • Severe kidney disease requiring dialysis
  • History of organ transplantation
  • Active substance abuse or addiction
  • Inability to follow study procedures or attend scheduled visits

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
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
San Camillo Forlanini Hospital Rome Italy
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
Penta Hospitals SK a.s. Rimavska Sobota Slovakia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Centrul De Diagnostic Si Tratament Provita S.A. Bucharest Romania
Synexus Bulgaria EOOD Sofia Bulgaria
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
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
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
CHC MontLegia Liege Belgium
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centre Hospitalier Universitaire De Rennes Rennes France
Poliklinika Solmed d.o.o. Zagreb Croatia
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Hospital Universitario De Canarias La Laguna Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Universita Degli Studi Di Brescia Brescia Italy
Gastro LM s.r.o. Presov Slovakia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Centre Hospitalier Universitaire De Caen Normandie Caen France
Beaumont Hospital Dublin Ireland
UROMED Jakub Koteras Szczecin Poland
Gqcqf Biurpak Krwkvbnjt Son z osaz Klodzko Poland
Ikaegalap Fra Crayqaqr Ate Espakjykqclb Mgupdwbz Prague Czechia
Hlelfakf Uukwixstnqcoy Di Ly Pqbjgwbd Madrid Spain
Heokhdwl Uyqunugmdgbfd Maxurvj Dj Vyawbeykqg Santander Spain
Ggsfnskpfjp sovnkj Nove Zamky Slovakia
Pdogmysd Pfltngtu Lnanhsht lqfn mfdw Mctreeej Fga Jelenia Gora Poland
Skibqzugkiwafbv Puhftxhj Lefccayq du mloq Mvcmp Hxrqrgzm Sopot Poland
Pyoavuj Mzttgg Sua z Oinh Eye Prlgbaiwa Poniatowa Poland
Ciwdxr Hycrmunvtok Upzkphcrkyudv Dw Dojtt Dijon France
Feiickewm Piyz Lb Igqhiacydpnzh Bxkpgpacu Diu Hqrjtnsm Uaxykhpkxtpsb Lo Per Madrid Spain
Ithezlra dj Cxmffiwisvmr Hkkyqlnmykn Uvqmtbkwplyjl dt Sdwvs Eqjuhcn (rvfjsrs Saint Priest En Jarez France
Wzw Wlvjyq Imv Pktip Pizuwvxi Kixiwhr Warsaw Poland
Mgfepgdy Sqc z omsh Oświęcim Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
27.06.2018
Bulgaria Bulgaria
Not recruiting
27.06.2018
Croatia Croatia
Not recruiting
27.06.2018
Czechia Czechia
Not recruiting
27.06.2018
France France
Not recruiting
27.06.2018
Germany Germany
Not recruiting
27.06.2018
Hungary Hungary
Not recruiting
27.06.2018
Ireland Ireland
Not recruiting
27.06.2018
Italy Italy
Not recruiting
27.06.2018
Latvia Latvia
Not recruiting
27.06.2018
Poland Poland
Not recruiting
27.06.2018
Romania Romania
Not recruiting
27.06.2018
Slovakia Slovakia
Not recruiting
27.06.2018
Spain Spain
Not recruiting
27.06.2018

Trial locations

Investigated drugs:

Ozanimod is an oral medication used to treat moderate to severe Crohn’s disease. It works by modulating the immune system to reduce inflammation in the digestive tract. This medication helps maintain periods of remission (when symptoms are under control) and improves the appearance of the intestinal lining when viewed through an endoscope. It belongs to a class of drugs called sphingosine 1-phosphate receptor modulators, which help control inflammation by affecting how immune cells move through the body.

Investigated diseases:

Crohn’s Disease – A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly occurs in the small intestine and colon. The inflammation caused by Crohn’s disease often spreads deep into the layers of affected bowel tissue, creating patches of inflamed tissue surrounded by healthy areas. Common symptoms include abdominal pain, diarrhea, fatigue, weight loss, and reduced appetite. The disease typically develops gradually, with symptoms worsening over time if left untreated. The condition can lead to complications such as intestinal strictures, fistulas, and nutritional deficiencies.

Trial ID:
2023-510426-33-00
Protocol code:
RPC01-3203
Trial Phase:
Therapeutic confirmatory (Phase III)

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