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EUCTR2017-004292-31 | SNCTP000003309

Induktionsstudie 1 – Studie zur Bestimmung der Wirkung von oralem Ozanimod als Induktionstherapie, im Vergleich zu einem Placebo, bei Patienten mit mittelschweren bis schweren aktiven Morbus Crohn

Data source: BASEC (Imported from 25.05.2020), WHO (Imported from 22.03.2020)
Changed: 22.05.2020
Disease category: Erkrankungen des Verdauungssystems (nicht Krebs)

Brief description of trial (Source of data: BASEC)

In dieser Studie soll herausgefunden werden, wie sicher und wirksam Ozanimod als mögliche Behandlung von Morbus Crohn ist. Die Studienteilnahme wird maximal ca. 12 Wochen dauern.
Diese Studie richtet sich an erwachsene Patienten oder erwachsene Patientinnen mit diagnostiziertem mittelschweren bis schweren, aktivem Morbus Crohn.
In dieser Studie wird ein Vergleich zwischen Patienten, die Ozanimod erhalten, und Patienten, die ein Placebo (ein Scheinmedikament, das so aussieht wie das wirkstoffhaltige Prüfpräparat, aber keinen Wirkstoff enthält) erhalten, angestellt. Die Wahrscheinlichkeit, dass das wirkstoffhaltige Prüfpräparat erhalten wird, beträgt 67 % (2/3), und die Wahrscheinlichkeit, dass Placebo erhalten wird, beträgt 33 % (1/3). Ozanimod wurde von den zuständigen Behörden bisher noch nicht für die Behandlung von Morbus Crohn zugelassen. Die im Rahmen dieser Studie durchgeführte Behandlung mit Ozanimod wird noch erprobt.
An dieser Studie werden weltweit ca. 675 Patienten an ca. 325 Prüfzentren teilnehmen. In der Schweiz ist die Teilnahme von 16 Patienten geplant.

Health conditions investigated (Source of data: BASEC)

Mittelschwerer bis schwerer aktiver Morbus Crohn

Health conditions (Source of data: WHO)

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Die Studie umfasst 4 Besuche im Prüfzentrum. Der Besuch an Tag 1 kann ca. 7-8 Stunden in Anspruch nehmen. Die weiteren Besuche können jeweils 2–4 Stunden dauern.
In dieser Studie werden unter anderem Blut-, Gewebe- und Stuhlproben auf Biomarker untersucht. Bei Biomarkern handelt es sich um Substanzen wie Proteine (Eiweissstoffe), die Aufschluss darüber geben, wie das Medikament im Körper wirkt. Biomarkeruntersuchungen sind in dieser Studie obligatorisch.

Interventions (Source of data: WHO)


Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Criteria for participation in trial (Source of data: BASEC)

1. Männliches oder weibliches Geschlecht, Alter 18–75 Jahre (zum Zeitpunkt des Einschlusses)
2. Zum Zeitpunkt der ersten Verabreichung des Prüfpräparats seit mindestens 3 Monaten bestehende Symptomatik in Einklang mit der Diagnose Morbus Crohn.
3. Schriftliche Einwilligung nach Aufklärung vor der Durchführung jeglicher studienbezogenen Verfahren und Fähigkeit, den Ablaufplan zu befolgen
4. Bei Patientinnen im gebärfähigen Alter:
Bereitschaft, während der Studie bis zum Abschluss des Besuchs nach der 90-tägigen Sicherheitsnachbeobachtung eine sichere Empfängnisverhütungsmethode anzuwenden.

Exclusion criteria (Source of data: BASEC)

1. Vorliegen irgendeiner klinisch relevanter Erkrankung der Leber, des Nervensystems, des Herzens oder der Lunge, des Auges, des Hormonsystems, psychiatrische Erkrankungen oder einer anderen bedeutenden systemischen Erkrankung, die die Teilnahme an der Studie negativ beeinflussen könnte
2. Bei Frauen: Schwangerschaft, Stillzeit oder positiver Schwangerschaftstest
3. Verdacht auf Vorliegen eines nicht angemessen behandelten Abszesses in der Bauchhöhle oder eines analen Abszesses
4. Bekannte Entzündung der mittleren Augenhaut (innerhalb des letzten Jahres) oder Ansammlung von Flüssigkeit im Auge
5. Operative Entfernung oder Teilentfernung des Dickdarms, Teilentfernung des Dünndarms oder Anlage eines künstlichen Darmausgangs
6. Aktive Krebserkrankung innerhalb von 5 Jahren
7. Impfung mit einem Lebendimpfstoff oder einem abgeschwächtem Lebendimpfstoff innerhalb von 4 Wochen vor der ersten Dosis des Prüfpräparats

Inclusion/Exclusion Criteria (Source of data: WHO)

Inclusion criteria:
1. Male or female subjects aged 12 to 75 years (at Screening), inclusive with adolescents (12 to 17) with a body weight = 45 kg
2. Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to 17 years) will only enroll subjects who are 18 years of age or older. Enrollment of adolescent subjects will begin only after the applicable regulatory requirements for enrolling subjects in that age group have been satisfied and the necessary health authority agreements have been granted. Where national or regional guidelines for the definition of adolescence differ from the definition stated above, the national or regional guidelines may be used to determine eligibility. Subjects should not have any constraints under local regulations and must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events. For adolescents, a parent/legal guardian of the adolescent must sign the informed consent form. In addition, adolescent subjects must also agree to participate in the study by signing an assent form. A parent or guardian must be willing to supervise adherence to the protocol requirements. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF themselves to acknowledge their willingness to continue in the study
3. Subject has signs and symptoms consistent with a diagnosis of CD for at least 3 months (prior to first IP administration). The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histology report. (Note: endoscopy and histopathology confirmation may be obtained during Screening if no prior report is readily available).
4. Subject has met each of the following 2 criteria:
- a CDAI score = 220 and = 450
- an average daily stool frequency = 4 points and/or an abdominal pain of = 2 points
5. Subject has a SES-CD score of = 6 (or SES-CD = 4 in subjects with isolated ileal disease).
6. Subject has an inadequate response or loss of response to or is intolerant of at least 1 of the following CD treatments: corticosteroids, immunomodulators, biologic therapy (eg, ustekinumab, TNFa antagonists, or vedolizumab)
7. If the subject is taking the following background therapies for CD, a stable dose must be maintained as indicated below:
- oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) with a stable dose for at least 3 weeks prior to Screening endoscopy
- prednisone (doses = 20 mg per day) or equivalent with a stable dose for at least 2 weeks prior to Screening endoscopy
- budesonide therapy (doses = 9 mg per day) or beclomethasone doses = 5 mg/day at a stable dose for at least 2 weeks prior to the Screening
endoscopy
8. Subject at high risk (ie, family history, CD duration) for colonic malignancy has documented evidence of having had a surveillance colonoscopy within the last 2 years or according to local and national medical guidelines to evaluate for polyps, dysplasia, or malignancy. If there is no recent history of surveillance colonoscopy, this can be done as part of the colonoscopy performed during Screening. Any visualized adenomatous polyps must be removed and any suspicious lesi
Exclusion criteria:
1. Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study. 2. Subject is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study. 3. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation. 4. Subject has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy. 5. Subject has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome, or subject requires total parenteral nutrition. 6. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated. 7. Subject has documentation of positive test for toxin producing C. difficile, or PCR examination of the stool. 8. Subject has documentation of positive examination for pathogens. 9. Subject is pregnant, lactating, or has a positive serum ß-hCG measured during Screening. 10. Subject has any condition that would make implementation of the protocol or interpretation of the study difficult. 11. Subject has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) > 9%, or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy. 12. Subject has a history of uveitis or clinically confirmed diagnosis of macular edema. 13. Subject has a known active bacterial, viral, fungal, mycobacterial infection (including tuberculosis or atypical mycobacterial disease) or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening. 14. History or known presence of recurrent or chronic infection (eg, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed. 15. Subject has a history of cancer within 5 years, including solid tumors and hematological malignancies or colonic dysplasia that has not been completely removed. 16. Subject has a history of alcohol or drug abuse within 1 year prior to initiation of Screening
17. Hypersensitivity to active ingredients or excipients of ozanimod or placebo. 18. Prior participation in an ozanimod clinical study. 19. Subject has a history of primary nonresponse to 2 or more approved biologic agents or has been treated with 4 or more biologics for CD. 20. Subject has been treated with a biologic agent within 8 weeks or 5 elimination half-lives (whichever is shorter) prior to the first dose of IP. 21. Subject has a history of treatment with an investigational agent within 5 elimination half-lives of that agent prior to the first dose of IP. 22. Subject has received a live or live attenuated vaccine within 4 weeks prior to the first dose of IP. 23. Subject has received previous treatment with lymphocyte-depleting therapies. 24. Subject has received previous treatment with D-penicillamine, leflunomide, orthalidomide 25. Subject has received previous treatment with natalizumab or fingolimod or other S1P receptor modu

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004292-31

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004292-31-CZ

Further information on trial

Date trial registered

31.01.2018

Incorporation of the first participant

03.05.2018

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Source of data: WHO)

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Type of trial (Source of data: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Source of data: WHO)

Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Phase (Source of data: WHO)

Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Primary end point (Source of data: WHO)

Main Objective: Demonstrate the efficacy of ozanimod compared to placebo on the induction of clinical remission;Primary end point(s): Proportion of subjects with a CDAI score < 150 at Week 12;Timepoint(s) of evaluation of this end point: Subjects will be deemed a responder with respect to this endpoint if they meet the definition for CDAI Clinical Remission at Week 12.;
Secondary Objective: - Demonstrate the efficacy of ozanimod compared to placebo on induction of clinical response, endoscopic response, endoscopic
remission, and histologic improvement
- Evaluate the efficacy of ozanimod compared to placebo, in subjects who had previously received biologic therapy (eg, anti-IL-12, anti-IL-23, anti-TNF, or anti-integrin therapy)
- Demonstrate the efficacy of ozanimod compared to placebo on the induction of clinical remission and clinical response in adolescent subjects (aged 12 to 17 years, inclusive)
- Characterize the population pharmacokinetics (PK) and PK/pharmacodynamics (PD) relationship of ozanimod
- Demonstrate the safety and tolerability of ozanimod as induction therapy

Secundary end point (Source of data: WHO)


Secondary end point(s): Major Secondary Endpoints:
- Proportion of subjects with average daily abdominal pain score = 1
point, and average daily stool frequency score = 3 points with abdominal
pain and stool frequency no worse than baseline at Week 12
- Proportion of subjects with a Simple Endoscopic Score for Crohn's
Disease (SES-CD) score decrease from baseline of = 50% at Week 12
- Proportion of subjects with CDAI reduction from baseline of = 100
points or CDAI score < 150 at Week 12
- Proportion of subjects with CDAI reduction from baseline of = 100
points or CDAI score < 150 and SES-CD decrease from baseline of = 50%
at Week 12
;Timepoint(s) of evaluation of this end point: at Week 12

Contact information (Source of data: WHO)

Celgene International II Sàrl

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Bern, St Gallen, Zürich

Countries (Source of data: WHO)

Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Korea, Latvia, Moldova, New Zealand, Norway, Poland, Puerto Rico, Republic of, Republic of, Romania, Russian Federation, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Nicolas Horovitz, Celgence GmbH
+41 44 437 82 48
nhorovitz@celgene.com

Contact for general information (Source of data: WHO)

Barrett Levesque
3033 Science Park Road, Suite 300
Receptos Services, LLC
+18582917051
blevesque@celgene.com

Contact for scientific information (Source of data: WHO)

Barrett Levesque
3033 Science Park Road, Suite 300
Receptos Services, LLC
+18582917051
blevesque@celgene.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Celgene International II Sàrl

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2018-00850

Secondary ID (Source of data: WHO)

RPC01-3201;NCT03440372;2017-004292-31-LV