Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Phase 1

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

• Registration Number: EUCTR2017-004293-33-LT
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Male or female subjects aged 12 to 75 years (at Screening), inclusive
with adolescents in selected countries or sites (12 to 17) with a body
weight = 45 kg.
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.
2. 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.
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 systemic CD treatments:
corticosteroids, immunomodulators, biologic therapies (eg,
ustekinumab, TNFa antagonists, or vedolizumab)
7. If the subject is taking the following background therapies for CD, a
stable dose must be maintained throughout the study 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/per 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 lesion
confirmed free of cancer and/or dysplasia prior to randomization.
9. Female subjects of childbearing potential (FCPB):
Note: For the purposes of this study, a female patient is considered to be
of childbearing potential if she is = 12 years of age or has reached
menarche, whichever occurred first, and 1) has not undergone a
hysterectomy (the surgical removal of the uterus) or bilateral
oophorectomy (the surgical removal of both ovaries) or 2) has not been
postmenopausal for at least 24 consecutive months (that is, has had
menses at any time during the preceding 24 consecutive months).
Must

Exclusion Criteria

1. Subject has any clinically relevant cardiovascular hepatic,
neurological, pulmonary [severe respiratory disease (pulmonary fibrosis
or chronic obstructive pulmonary disease)], 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, ilealanal
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. •In the case
of prior SARS-CoV-2 infection, symptoms must have completely resolved
and based on Investigator assessment in consultation with the Clinical
Trial Physician / Medical Monitor, there are no sequelae that would place
the participant at a higher risk of receiving investigational treatment. 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 a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified